Sample records for quality standards required

  1. 40 CFR 131.6 - Minimum requirements for water quality standards submission.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Minimum requirements for water quality standards submission. 131.6 Section 131.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS General Provisions § 131.6 Minimum requirements for water quality standards submission. The...

  2. 40 CFR 131.6 - Minimum requirements for water quality standards submission.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Minimum requirements for water quality standards submission. 131.6 Section 131.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS General Provisions § 131.6 Minimum requirements for water quality standards submission. The...

  3. Comparative Analysis of the Specifications on the Power Quality of the European Union and the Russian Federation

    NASA Astrophysics Data System (ADS)

    Ded, A. V.; Maltsev, V. N.; Sikorski, S. P.

    2018-04-01

    Since July 2014 the interstate standard GOST 32144-2013 is the only document that defines standard requirements for the power quality in the territory of the Russian Federation. The new standard preamble specifies that this document considers the requirements of the European regional standard EN 50160-2010. However, GOST authors established the degree of standards conformity as nonequivalent. In connection with Russia's accession to the World Trade Organization (WTO) all requirements for goods including electric energy should correspond the international standard requirements. The article analyzes the above standard requirements and assesses the requirements for the power quality standards used in the European Union and in the Russian Federation.

  4. 7 CFR 160.11 - Quality requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality requirements. 160.11 Section 160.11 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... STANDARDS FOR NAVAL STORES General § 160.11 Quality requirements. The several standards for spirits of...

  5. 21 CFR 900.11 - Requirements for certification.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MAMMOGRAPHY QUALITY STANDARDS ACT MAMMOGRAPHY Quality Standards and Certification § 900.11 Requirements for... FDA, facilities are required to meet the quality standards in § 900.12 and to be accredited by an...

  6. 15 CFR 996.11 - Development of standards for a hydrographic product or class.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality... adopt or reject the standard as the NOAA Quality Assurance Program Standard for the particular...

  7. 21 CFR 900.21 - Application for approval as a certification agency.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... description of the mammography quality standards the applicant will require facilities to meet and, for those... certification standards the applicant will require facilities to meet are the quality standards published under... SERVICES (CONTINUED) MAMMOGRAPHY QUALITY STANDARDS ACT MAMMOGRAPHY States as Certifiers § 900.21...

  8. 40 CFR 121.21 - When Administrator certifies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... activity requiring a license or permit will not violate applicable water quality standards will be required... respect to those water quality standards promulgated by him; or (b) Water quality standards have been... Section 121.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS STATE...

  9. 40 CFR 121.21 - When Administrator certifies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... activity requiring a license or permit will not violate applicable water quality standards will be required... respect to those water quality standards promulgated by him; or (b) Water quality standards have been... Section 121.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS STATE...

  10. 40 CFR 131.8 - Requirements for Indian Tribes to administer a water quality standards program.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Requirements for Indian Tribes to administer a water quality standards program. 131.8 Section 131.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS General Provisions § 131.8 Requirements for Indian Tribes to administer a wate...

  11. 40 CFR 131.8 - Requirements for Indian Tribes to administer a water quality standards program.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Requirements for Indian Tribes to administer a water quality standards program. 131.8 Section 131.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS General Provisions § 131.8 Requirements for Indian Tribes to administer a wate...

  12. Quality assurance tendering and awarding contracts

    NASA Astrophysics Data System (ADS)

    1994-12-01

    Standards relating to quality control can be significantly useful when tendering for and awarding contracts. However, because it is sometimes difficult to express these standards in palpable economic terms, they can (practically) never be applied as criteria for awarding contracts in accordance with U.A.R. (Uniform General Standards) 1986. Therefore it would be advisable in the future to regard the availability of a (certified) system of quality control as being a standard requirement. To this end, a paragraph setting requirements for a quality control plan should be included in the specification. A quality control plan will be required on awarding a contract. This envisaged scenario can best achieved through a transitional phase. During this period there will be opportunity enough for removing any shortcomings in the wording and for considering standards to be required and assessment procedures.

  13. 30 CFR 74.9 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... registration under ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements... ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements. The Director of... management audits. Upon request, applicants or approval holders must allow NIOSH to inspect the quality...

  14. 40 CFR 131.35 - Colville Confederated Tribes Indian Reservation.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.35 Colville Confederated Tribes Indian Reservation. The water quality standards applicable to the waters within the... these Federal water quality standards to prescribe minimum water quality requirements for the surface...

  15. 78 FR 49409 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... national ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit a plan...

  16. 48 CFR 46.202-4 - Higher-level contract quality requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... quality requirements. 46.202-4 Section 46.202-4 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-4 Higher-level contract quality requirements. (a) Requiring compliance with higher-level quality standards is appropriate in...

  17. 48 CFR 46.202-4 - Higher-level contract quality requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... quality requirements. 46.202-4 Section 46.202-4 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-4 Higher-level contract quality requirements. (a) Requiring compliance with higher-level quality standards is appropriate in...

  18. 48 CFR 46.202-4 - Higher-level contract quality requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... quality requirements. 46.202-4 Section 46.202-4 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-4 Higher-level contract quality requirements. (a) Requiring compliance with higher-level quality standards is appropriate in...

  19. 48 CFR 46.202-4 - Higher-level contract quality requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... quality requirements. 46.202-4 Section 46.202-4 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-4 Higher-level contract quality requirements. (a) Requiring compliance with higher-level quality standards is appropriate in...

  20. 78 FR 65593 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ...] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... revised national ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit...

  1. 78 FR 53709 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2008 Ozone National Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA... ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit a plan for the...

  2. 30 CFR 74.9 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... specifications and are reliable, safe, effective, and otherwise suitable for their intended use. To establish and... registration under ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements... ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements. The Director of...

  3. 30 CFR 74.9 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH COAL MINE... registration under ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements... ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements. The Director of...

  4. 77 FR 67366 - Federal Acquisition Regulation; Information Collection; Quality Assurance Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ..., acceptance, warranty, and other measures associated with quality requirements. Standard clauses related to...; Information Collection; Quality Assurance Requirements AGENCY: Department of Defense (DOD), General Services... requirement concerning quality assurance requirements. Public comments are particularly invited on: Whether...

  5. 78 FR 34964 - Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ...] Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan... Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements'' which published in the... the 2008 ozone national ambient air quality standards (NAAQS) (the ``2008 ozone NAAQS'') that were...

  6. 15 CFR 996.11 - Development of standards for a hydrographic product or class.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality... class. (a) NOAA shall work, to the extent practicable, through existing, recognized, standards bodies in...

  7. 15 CFR 996.11 - Development of standards for a hydrographic product or class.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality... class. (a) NOAA shall work, to the extent practicable, through existing, recognized, standards bodies in...

  8. 15 CFR 996.11 - Development of standards for a hydrographic product or class.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality... class. (a) NOAA shall work, to the extent practicable, through existing, recognized, standards bodies in...

  9. 15 CFR 996.11 - Development of standards for a hydrographic product or class.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality... class. (a) NOAA shall work, to the extent practicable, through existing, recognized, standards bodies in...

  10. 48 CFR 46.202-4 - Higher-level contract quality requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Higher-level contract... REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-4 Higher-level contract quality requirements. (a) Requiring compliance with higher-level quality standards is appropriate in...

  11. 42 CFR 488.301 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25... participation requirements subsequent to finding substandard quality of care during a standard survey. Facility... substandard quality of care during an abbreviated standard survey. Skilled nursing facility (SNF) means a...

  12. 42 CFR 488.301 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25... participation requirements subsequent to finding substandard quality of care during a standard survey. Facility... substandard quality of care during an abbreviated standard survey. Skilled nursing facility (SNF) means a...

  13. 42 CFR 488.301 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25... participation requirements subsequent to finding substandard quality of care during a standard survey. Facility... substandard quality of care during an abbreviated standard survey. Skilled nursing facility (SNF) means a...

  14. 42 CFR 488.301 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25... participation requirements subsequent to finding substandard quality of care during a standard survey. Facility... substandard quality of care during an abbreviated standard survey. Skilled nursing facility (SNF) means a...

  15. 42 CFR 488.301 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... requirements under § 483.13, Resident behavior and facility practices, § 483.15, Quality of life, or § 483.25... participation requirements subsequent to finding substandard quality of care during a standard survey. Facility... substandard quality of care during an abbreviated standard survey. Skilled nursing facility (SNF) means a...

  16. [Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

    PubMed

    Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

    2013-02-01

    The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  17. Air Quality Modeling | Air Quality Planning & Standards | US ...

    EPA Pesticide Factsheets

    2016-06-08

    The basic mission of the Office of Air Quality Planning and Standards is to preserve and improve the quality of our nation's air. One facet of accomplishing this goal requires that new and existing air pollution sources be modeled for compliance with the National Ambient Air Quality Standards (NAAQS).

  18. 15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality Assurance Program for Hydrographic Products § 996.12 Development of standards compliance tests for...

  19. 48 CFR 46.202-3 - Standard inspection requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-3 Standard inspection... and tests while work is in process; and (3) Require the contractor to keep complete, and make available to the Government, records of its inspection work. [48 FR 42415, Sept. 19, 1983. Redesignated at...

  20. 48 CFR 46.202-3 - Standard inspection requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-3 Standard inspection... and tests while work is in process; and (3) Require the contractor to keep complete, and make available to the Government, records of its inspection work. [48 FR 42415, Sept. 19, 1983. Redesignated at...

  1. 48 CFR 46.202-3 - Standard inspection requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-3 Standard inspection... and tests while work is in process; and (3) Require the contractor to keep complete, and make available to the Government, records of its inspection work. [48 FR 42415, Sept. 19, 1983. Redesignated at...

  2. 48 CFR 46.202-3 - Standard inspection requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-3 Standard inspection... and tests while work is in process; and (3) Require the contractor to keep complete, and make available to the Government, records of its inspection work. [48 FR 42415, Sept. 19, 1983. Redesignated at...

  3. 76 FR 38384 - Agency Information Collection Activities; Proposed Collection; Comment Request; Water Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... Activities; Proposed Collection; Comment Request; Water Quality Standards (Renewal) AGENCY: Environmental... States and certain authorized Indian Tribes that adopt water quality standards under the Clean Water Act; and water dischargers subject to certain requirements related to water quality standards in the Great...

  4. 7 CFR 58.446 - Quality requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality requirements. 58.446 Section 58.446... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese. The quality requirements for Cheddar cheese shall be in accordance with the U.S. Standards for Grades of...

  5. 40 CFR 131.4 - State authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS... reviewing, establishing, and revising water quality standards. As recognized by section 510 of the Clean Water Act, States may develop water quality standards more stringent than required by this regulation...

  6. Review and comparison of quality standards, guidelines and regulations for laboratories.

    PubMed

    Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

    2012-01-01

    The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

  7. 76 FR 54293 - Review of National Ambient Air Quality Standards for Carbon Monoxide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-31

    ...This rule is being issued at this time as required by a court order governing the schedule for completion of this review of the air quality criteria and the national ambient air quality standards (NAAQS) for carbon monoxide (CO). Based on its review, the EPA concludes the current primary standards are requisite to protect public health with an adequate margin of safety, and is retaining those standards. After review of the air quality criteria, EPA further concludes that no secondary standard should be set for CO at this time. EPA is also making changes to the ambient air monitoring requirements for CO, including those related to network design, and is updating, without substantive change, aspects of the Federal reference method.

  8. Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

    PubMed

    Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

    2006-06-01

    A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency assessments, and processes for identifying and addressing opportunities for improvement. Recommendations were developed for a stepwise approach towards achieving ISO 15189 standards, including 3 levels of quality components. The ISO 15189 standard provides a sound framework for veterinary laboratories aspiring to meet international quality standards.

  9. DEVELOPMENT OF A NATIONAL CONSENSUS STANDARD FOR QUALITY ASSURANCE FOR ENVIRONMENTAL PROGRAMS

    EPA Science Inventory

    Decisions on where and how to clean-up Federally-owned facilities contaminated by mixtures of hazardous chemical and radioactive wastes requires that quality environmental data be obtained. he Federal Government currently using several different standards or sets of requirements ...

  10. Lessons Learned on Quality (of) Standards

    NASA Astrophysics Data System (ADS)

    Gerlich, Rainer; Gerlich, Ralf

    2011-08-01

    Standards are used to describe and ensure the quality of products, services and processes throughout almost all branches of industry, including the field of software engineering. Contractors and suppliers are obligated by their customers and certification authorities to follow a certain set of standards during development. For example, a customer can easier actively participate in and control the contractor's process when enforcing a standard process..However, as with any requirement, a standard may also impede the contractor or supplier in assuring actual quality of the product in the sense of fitness for the purpose intended by the customer.This is the case when a standard defines specific quality assurance activities requiring a considerable amount of effort while other more efficient but equivalent or even superior approaches are blocked. Then improvement of the ratio between cost and quality exceeding miniscule advances is heavily impeded.While in some parts being too specific in defining the mechanisms of the enforced process, standards are sometimes too weak in defining the principles or goals on control of product quality.Therefore this paper addresses the following issues: (1) Which conclusions can be drawn on the quality and efficiency of a standard? (2) If and how is it possible to improve or evolve a standard? (3) How well does a standard guide a user towards high quality of the end product?One conclusion is that the analyzed standards do interfere with technological innovation, though the standards leave a lot of freedom for concretization and are understood as technology-independent.Another conclusion is that standards are not only a matter of quality but also a matter of competitiveness of the industry depending on resulting costs and time-to- market. When the costs induced by a standard are not adequate to the achievable quality, industry encounters a significant disadvantage.

  11. Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

    PubMed

    Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

    2015-04-01

    The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. 42 CFR 493.1425 - Standard; Testing personnel responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

  13. 77 FR 65478 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Indiana; Michigan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-29

    ... particle national ambient air quality standards (2006 PM 2.5 NAAQS). The infrastructure requirements are... 24- Hour Fine Particle (PM 2.5 ) National Ambient Air Quality Standards (NAAQS)'' (2009 Memo). The...

  14. 78 FR 63877 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ...] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection... ambient air quality standard (NAAQS). EPA is approving this SIP revision in accordance with the...

  15. 7 CFR 58.446 - Quality requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Monterey (Monterey Jack) Cheese. (d) Swiss cheese, Emmentaler cheese. The quality requirements for Swiss cheese, Emmentaler cheese shall be in accordance with the U.S. Standards for Grades for Swiss Cheese... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese. The...

  16. 7 CFR 58.446 - Quality requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Monterey (Monterey Jack) Cheese. (d) Swiss cheese, Emmentaler cheese. The quality requirements for Swiss cheese, Emmentaler cheese shall be in accordance with the U.S. Standards for Grades for Swiss Cheese... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese. The...

  17. 7 CFR 58.446 - Quality requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Monterey (Monterey Jack) Cheese. (d) Swiss cheese, Emmentaler cheese. The quality requirements for Swiss cheese, Emmentaler cheese shall be in accordance with the U.S. Standards for Grades for Swiss Cheese... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese. The...

  18. 7 CFR 58.446 - Quality requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Monterey (Monterey Jack) Cheese. (d) Swiss cheese, Emmentaler cheese. The quality requirements for Swiss cheese, Emmentaler cheese shall be in accordance with the U.S. Standards for Grades for Swiss Cheese... Products Bearing Usda Official Identification § 58.446 Quality requirements. (a) Cheddar cheese. The...

  19. AN APPROACH FOR EVALUATING THE EFFECTIVENESS OF VARIOUS OZONE AIR QUALITY STANDARDS FOR PROTECTING TREES

    EPA Science Inventory

    We demonstrate an approach for evaluating the level of protection attained using a variety of forms and levels of past, current, and proposed Air Quality Standards (AQSs). The U.S. Clean Air Act requires the establishment of ambient air quality standards to protect health and pub...

  20. 40 CFR 122.44 - Establishing limitations, standards, and other permit conditions (applicable to State NPDES...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CWA; (6) Ensure consistency with the requirements of a Water Quality Management plan approved by EPA..., or controls a pollutant or practice not limited in the permit. (d) Water quality standards and State... quality standards established under section 303 of the CWA, including State narrative criteria for water...

  1. [Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

    2011-12-01

    The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

  2. Review of Special Standards in Quality Management Systems Audits in Automotive Production

    NASA Astrophysics Data System (ADS)

    Šurinová, Yulia

    2013-12-01

    Quality management systems (QMS) in automotive industry generally have several differences in comparison with other industrial branches. Different customers have their own specific requirements, including requirements for quality audits. Audits are one of the coretools of quality management to make the PDCA (Plan - Do - Check - Act) cycle work. As a matter of fact, compliance with ISO/TS 16949:2009 requirements is a condition for supplying the automotive industry. However, there are some standards which co-exist together with the ISO 9001 based management systems and technical specification for QMS in automotive ISO/TS16949. Which are those specific standards in automotive industry and what standard to use and why - those are the questions to be answered in this paper. The aim of the paper is to review what standards are used for audits implementation in automotive industry in the Slovak Republic, and why the organizations keep following those "extra" standards even if certification for ISO/TS 16949 is required by all the car makers. The paper is structured as follows: after short introduction to the topic and related terms, presented is our methodology. . In the third section, the achieved results are discussed. And finally, the principal findings of the paper, limitations and conclusions are presented.

  3. 40 CFR 35.910-7 - Fiscal Year 1977 Supplemental Appropriations Act allotments.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (secondary treatment, more stringent treatment required to meet water quality standards, and interceptor..., and V (secondary treatment, more stringent treatment required to meet water quality standards... Mexico 3,272,000 New York 105,294,000 North Carolina 20,722,000 North Dakota 3,272,000 Ohio 55,522,000...

  4. 40 CFR 121.30 - Review and advice.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... determinations, definitions and interpretations with respect to the meaning and content of water quality... the application of all applicable water quality standards in particular cases and in specific... by dischargers with the conditions and requirements of applicable water quality standards. In cases...

  5. 40 CFR 121.30 - Review and advice.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... determinations, definitions and interpretations with respect to the meaning and content of water quality... the application of all applicable water quality standards in particular cases and in specific... by dischargers with the conditions and requirements of applicable water quality standards. In cases...

  6. 77 FR 42997 - Approval and Promulgation of Implementation Plans; Tennessee; 110(a)(1) and (2) Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ...-Hour Ozone National Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA). ACTION... ambient air quality standards (NAAQS). Section 110(a) of the CAA requires that each state adopt and submit... National Ambient Air Quality Standards.'' \\1\\ Two elements identified in section 110(a)(2) are not governed...

  7. 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.

  8. 42 CFR 410.143 - Requirements for approved accreditation organizations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Notice of any proposed changes in its accreditation standards and requirements or evaluation process. If... enforcement of its standards to a set of quality standards (described in § 410.144) and processes when any of the following conditions exist: (i) CMS imposes new requirements or changes its process for approving...

  9. 40 CFR 131.8 - Requirements for Indian Tribes to administer a water quality standards program.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the Tribe has previously qualified for eligibility or “treatment as a state” under a Clean Water Act or Safe Drinking Water Act program, the Tribe need only provide the required information which has... for Indian Tribes to administer a water quality standards program. (a) The Regional Administrator, as...

  10. 40 CFR 131.8 - Requirements for Indian Tribes to administer a water quality standards program.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the Tribe has previously qualified for eligibility or “treatment as a state” under a Clean Water Act or Safe Drinking Water Act program, the Tribe need only provide the required information which has... for Indian Tribes to administer a water quality standards program. (a) The Regional Administrator, as...

  11. 40 CFR 131.8 - Requirements for Indian Tribes to administer a water quality standards program.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the Tribe has previously qualified for eligibility or “treatment as a state” under a Clean Water Act or Safe Drinking Water Act program, the Tribe need only provide the required information which has... for Indian Tribes to administer a water quality standards program. (a) The Regional Administrator, as...

  12. Taking Stock: An Analysis of Delaware's High School Standards and Course Requirements

    ERIC Educational Resources Information Center

    Achieve, Inc., 2005

    2005-01-01

    Delaware's secretary of education and the president of the State Board of Education asked Achieve to provide an analysis of the quality of Delaware's high school content standards and its course-taking requirements. In assisting Delaware in its commitment to raising the quality of its expectations for high school graduates, Achieve examined the…

  13. The Benefits and Future of Standards: Metadata and Beyond

    NASA Astrophysics Data System (ADS)

    Stracke, Christian M.

    This article discusses the benefits and future of standards and presents the generic multi-dimensional Reference Model. First the importance and the tasks of interoperability as well as quality development and their relationship are analyzed. Especially in e-Learning their connection and interdependence is evident: Interoperability is one basic requirement for quality development. In this paper, it is shown how standards and specifications are supporting these crucial issues. The upcoming ISO metadata standard MLR (Metadata for Learning Resource) will be introduced and used as example for identifying the requirements and needs for future standardization. In conclusion a vision of the challenges and potentials for e-Learning standardization is outlined.

  14. Standard classification of software documentation

    NASA Technical Reports Server (NTRS)

    Tausworthe, R. C.

    1976-01-01

    General conceptual requirements for standard levels of documentation and for application of these requirements to intended usages. These standards encourage the policy to produce only those forms of documentation that are needed and adequate for the purpose. Documentation standards are defined with respect to detail and format quality. Classes A through D range, in order, from the most definitive down to the least definitive, and categories 1 through 4 range, in order, from high-quality typeset down to handwritten material. Criteria for each of the classes and categories, as well as suggested selection guidelines for each are given.

  15. 77 FR 35285 - Approval of Air Quality Implementation Plan; Arizona; Attainment Plan for 1997 8-Hour Ozone Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... Quality Implementation Plan; Arizona; Attainment Plan for 1997 8-Hour Ozone Standard AGENCY: U.S... 1997 8-hour ozone national ambient air quality standards (NAAQS) in the Phoenix-Mesa nonattainment area... required for ozone nonattainment areas under title I, part D, subpart 1 of the Clean Air Act (CAA) for the...

  16. Quality Manual

    NASA Astrophysics Data System (ADS)

    Koch, Michael

    The quality manual is the “heart” of every management system related to quality. Quality assurance in analytical laboratories is most frequently linked with ISO/IEC 17025, which lists the standard requirements for a quality manual. In this chapter examples are used to demonstrate, how these requirements can be met. But, certainly, there are many other ways to do this.

  17. ISO 9000 Quality Management System

    NASA Astrophysics Data System (ADS)

    Hadjicostas, Evsevios

    The ISO 9000 series describes a quality management system applicable to any organization. In this chapter we present the requirements of the standard in a way that is as close as possible to the needs of analytical laboratories. The sequence of the requirements follows that in the ISO 9001:2008 standard. In addition, the guidelines for performance improvement set out in the ISO 9004 are reviewed. Both standards should be used as a reference as well as the basis for further elaboration.

  18. Infrastructure SIP Requirements and Guidance

    EPA Pesticide Factsheets

    The Clean Air Act requires states to submit SIPs that implement, maintain, and enforce a new or revised national ambient air quality standard (NAAQS) within 3 years of EPA issuing the standard. The Infrastructure SIP is required for all states.

  19. 45 CFR 156.1120 - Quality rating system.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Quality rating system. 156.1120 Section 156.1120 Public Welfare Department of Health and Human Services REQUIREMENTS RELATING TO HEALTH CARE ACCESS HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES Quality...

  20. Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

    PubMed

    Fulga, Netta

    2013-06-01

    Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

  1. A Framework for Evaluating the Software Product Quality of Pregnancy Monitoring Mobile Personal Health Records.

    PubMed

    Idri, Ali; Bachiri, Mariam; Fernández-Alemán, José Luis

    2016-03-01

    Stakeholders' needs and expectations are identified by means of software quality requirements, which have an impact on software product quality. In this paper, we present a set of requirements for mobile personal health records (mPHRs) for pregnancy monitoring, which have been extracted from literature and existing mobile apps on the market. We also use the ISO/IEC 25030 standard to suggest the requirements that should be considered during the quality evaluation of these mPHRs. We then go on to design a checklist in which we contrast the mPHRs for pregnancy monitoring requirements with software product quality characteristics and sub-characteristics in order to calculate the impact of these requirements on software product quality, using the ISO/IEC 25010 software product quality standard. The results obtained show that the requirements related to the user's actions and the app's features have the most impact on the external sub-characteristics of the software product quality model. The only sub-characteristic affected by all the requirements is Appropriateness of Functional suitability. The characteristic Operability is affected by 95% of the requirements while the lowest degrees of impact were identified for Compatibility (15%) and Transferability (6%). Lastly, the degrees of the impact of the mPHRs for pregnancy monitoring requirements are discussed in order to provide appropriate recommendations for the developers and stakeholders of mPHRs for pregnancy monitoring.

  2. Assessment of Soil Environmental Quality in Huangguoshu Waterfalls Scenic Area

    NASA Astrophysics Data System (ADS)

    Luo, Rongbin; Feng, Kaiyu; Gu, Bo; Xu, Chengcheng

    2018-03-01

    This paper concentrates on five major heavy metal pollutants as soil environmental quality evaluation factors, respectively Lead (Pb), Cadmium (Cd), Mercury (Hg), Arsenic (As), Chromium (Cr), based on the National Soil Environmental Quality Standards (GB15618 - 1995), we used single factor index evaluation model of soil environmental quality and comprehensive index evaluation model to analyze surface soil environmental quality in the Huangguoshu Waterfalls scenic area. Based on surface soil analysis, our results showed that the individual contamination index, Pb, Hg, As and Cr in the Huangguoshu Waterfalls scenic area met class I according to requirements of National Soil Environmental Quality Standards, which indicated that Pb, Hg, As and Cr were not main heavy metal pollutants in this area, but the individual contamination index of Cd in soil was seriously exceeded National Soil Environmental Quality Standards’ requirement. Soil environmental quality in Shitouzhai, Luoshitan, Langgong Hongyan Power Plant have exceeded the requirement of National Soil Environmental Quality Standards “0.7< Pc≤ 1.0” (Alert Level), these soils had been slightly polluted; the classification of soil environmental quality assessment in Longgong downstream area was above “Alert Level”, it indicated that soil in this area was not polluted. Above all, relevant measures for soil remediation are put forward.

  3. [Laboratory accreditation and proficiency testing].

    PubMed

    Kuwa, Katsuhiko

    2003-05-01

    ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

  4. 40 CFR 52.275 - Particulate matter control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... National Ambient Air Quality Standards or any other applicable requirement of the Clean Air Act. (1) South Coast Air Quality Management District. (i) Rule 401, submitted on January 12, 1999. [43 FR 25675, June... interfere with the attainment and maintenance of the National Ambient Air Quality Standards. (1) Amador...

  5. 24 CFR 982.621 - Manufactured home: Housing quality standards.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

  6. 24 CFR 982.621 - Manufactured home: Housing quality standards.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

  7. 24 CFR 982.621 - Manufactured home: Housing quality standards.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

  8. 24 CFR 982.621 - Manufactured home: Housing quality standards.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

  9. 24 CFR 982.621 - Manufactured home: Housing quality standards.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Manufactured home: Housing quality... Types Manufactured Home § 982.621 Manufactured home: Housing quality standards. A manufactured home must meet all the HQS performance requirements and acceptability criteria in § 982.401. A manufactured home...

  10. 75 FR 65594 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards AGENCY: Environmental... in Ohio Administrative Code (OAC) Chapter 3745-17, ``Particulate Matter Standards.'' The revisions were submitted by Ohio EPA to satisfy the State's 5-year review requirements. The particulate matter...

  11. 42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: General laboratory systems quality... for Nonwaived Testing General Laboratory Systems § 493.1239 Standard: General laboratory systems... laboratory systems requirements specified at §§ 493.1231 through 493.1236. (b) The general laboratory systems...

  12. Software archeology: a case study in software quality assurance and design

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

    Macdonald, John M; Lloyd, Jane A; Turner, Cameron J

    2009-01-01

    Ideally, quality is designed into software, just as quality is designed into hardware. However, when dealing with legacy systems, demonstrating that the software meets required quality standards may be difficult to achieve. As the need to demonstrate the quality of existing software was recognized at Los Alamos National Laboratory (LANL), an effort was initiated to uncover and demonstrate that legacy software met the required quality standards. This effort led to the development of a reverse engineering approach referred to as software archaeology. This paper documents the software archaeology approaches used at LANL to document legacy software systems. A case studymore » for the Robotic Integrated Packaging System (RIPS) software is included.« less

  13. Infrastructure State Implementation Plan (SIP) Requirements and Guidance

    EPA Pesticide Factsheets

    The Clean Air Act requires states to submit SIPs that implement, maintain, and enforce a new or revised national ambient air quality standard (NAAQS) within 3 years of EPA issuing the standard. The Infrastructure SIP is required for all states.

  14. Monitoring design for assessing compliance with numeric nutrient standards for rivers and streams using geospatial variables.

    PubMed

    Williams, Rachel E; Arabi, Mazdak; Loftis, Jim; Elmund, G Keith

    2014-09-01

    Implementation of numeric nutrient standards in Colorado has prompted a need for greater understanding of human impacts on ambient nutrient levels. This study explored the variability of annual nutrient concentrations due to upstream anthropogenic influences and developed a mathematical expression for the number of samples required to estimate median concentrations for standard compliance. A procedure grounded in statistical hypothesis testing was developed to estimate the number of annual samples required at monitoring locations while taking into account the difference between the median concentrations and the water quality standard for a lognormal population. For the Cache La Poudre River in northern Colorado, the relationship between the median and standard deviation of total N (TN) and total P (TP) concentrations and the upstream point and nonpoint concentrations and general hydrologic descriptors was explored using multiple linear regression models. Very strong relationships were evident between the upstream anthropogenic influences and annual medians for TN and TP ( > 0.85, < 0.001) and corresponding standard deviations ( > 0.7, < 0.001). Sample sizes required to demonstrate (non)compliance with the standard depend on the measured water quality conditions. When the median concentration differs from the standard by >20%, few samples are needed to reach a 95% confidence level. When the median is within 20% of the corresponding water quality standard, however, the required sample size increases rapidly, and hundreds of samples may be required. Copyright © by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America, Inc.

  15. The case for regime-based water quality standards

    USGS Publications Warehouse

    Poole, Geoffrey C.; Dunham, J.B.; Keenan, D.M.; Sauter, S.T.; McCullough, D.A.; Mebane, Christopher; Lockwood, Jeffrey C.; Essig, Don A.; Hicks, Mark P.; Sturdevant, Debra J.; Materna, E.J.; Spalding, M.; Risley, John; Deppman, Marianne

    2004-01-01

    Conventional water quality standards have been successful in reducing the concentration of toxic substances in US waters. However, conventional standards are based on simple thresholds and are therefore poorly structured to address human-caused imbalances in dynamic, natural water quality parameters, such as nutrients, sediment, and temperature. A more applicable type of water quality standarda??a a??regime standarda??a??would describe desirable distributions of conditions over space and time within a stream network. By mandating the protection and restoration of the aquatic ecosystem dynamics that are required to support beneficial uses in streams, well-designed regime standards would facilitate more effective strategies for management of natural water quality parameters.

  16. A Contextual Analysis of the Quality Core Curriculum and the Georgia Performance Standards in Seventh Grade Social Studies: A Critical Race Perspective

    ERIC Educational Resources Information Center

    Candis, Matthew Reese

    2013-01-01

    In 1985 the state of Georgia introduced the Quality Core Curriculum (QCC) in accordance with the Quality Basic Education (QBE) Act. These learning standards identified the content knowledge that students were required to learn in each subject area at all grade levels. The QCC was replaced by the Georgia Performance Standards (GPS) to identify the…

  17. Quality assurance program requirements, Amendment 5 (9-26-79) to August 1973 issue

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

    Not Available

    This standard sets forth general requirements for planning, managing, conducting, and evaluating quality assurance programs for reactor development and test facility projects and associated processes, structures, components, and systems. These quality assurance requirements are based on proven practices and provide the means of control and verification whereby those responsible fo poject management can assure that the quality required for safe, reliable, and economical operation will be achieved. The objective of the program of the programs covered by this standard is to assure that structures, components, systems, and facilities are designed, developed, manufactured, constructed, operated, and maintained in compliance with establishedmore » engineering criteria. To achieve this objective, controls are to be established and implemented at predetermined points, and necessary action taken to prevent, detect, and correct any deficiencies.« less

  18. Review of the Primary National Ambient Air Quality Standard for Sulfur Oxides: Risk and Exposure Assessment

    EPA Science Inventory

    Sulfur oxides are one of the six major air pollutants for which EPA has issued air quality criteria and established national ambient air quality standards (NAAQS) based on those criteria. The Clear Air Act (CAA) requires EPA to periodically review and revise, as appropriate, exis...

  19. AMBIENT AIR MONITORING STRATEGY

    EPA Science Inventory

    The Clean Air Act requires EPA to establish national ambient air quality standards and to regulate as necessary, hazardous air pollutants. EPA uses ambient air monitoring to determine current air quality conditions, and to assess progress toward meeting these standards and relat...

  20. 75 FR 38023 - Approval and Promulgation of Air Quality Implementation Plans; California; Motor Vehicle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-01

    ... the enhanced program performance standard evaluations to address: (1) A different attainment year for... the enhanced program performance standard evaluations, we concluded that the 2009 I/M Revision met the... national ambient air quality standards (NAAQSs) or any other applicable requirement of the Act. In so doing...

  1. Standard Review Plan for Environmental Restoration Program Quality Management Plans. Revision 2

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

    Not Available

    1993-12-01

    The Department of Energy, Richland Operations Office (RL) Manual Environmental Restoration Program Quality System Requirements (QSR) for the Hanford Site, defines all quality requirements governing Hanford Environmental Restoration (ER) Program activities. The QSR requires that ER Program participants develop Quality Management Plans (QMPs) that describe how the QSR requirements will be implemented for their assigned scopes of work. This standard review plan (SRP) describes the ER program participant responsibilities for submittal of QMPs to the RL Environmental Restoration Division for review and the RL methodology for performing the reviews of participant QMPS. The SRP serves the following functions: acts asmore » a guide in the development or revision of QMPs to assure that the content is complete and adequate; acts as a checklist to be used by the RL staff in their review of participant QMPs; acts as an index or matrix between the requirements of the QSR and implementing methodologies described in the QMPs; decreases the time and subjectivity of document reviews; and provides a formal, documented method for describing exceptions, modifications, or waivers to established ER Program quality requirements.« less

  2. 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

  3. 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.

  4. 15 CFR 996.10 - Submission and selection of hydrographic products for the development of standards and compliance...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC...: Hydrographic Product Quality Assurance Program, Office of Coast Survey, NOAA, 1315 East West Highway, Silver...

  5. 15 CFR 996.10 - Submission and selection of hydrographic products for the development of standards and compliance...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC...: Hydrographic Product Quality Assurance Program, Office of Coast Survey, NOAA, 1315 East West Highway, Silver...

  6. 15 CFR 996.10 - Submission and selection of hydrographic products for the development of standards and compliance...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC...: Hydrographic Product Quality Assurance Program, Office of Coast Survey, NOAA, 1315 East West Highway, Silver...

  7. 15 CFR 996.10 - Submission and selection of hydrographic products for the development of standards and compliance...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC...: Hydrographic Product Quality Assurance Program, Office of Coast Survey, NOAA, 1315 East West Highway, Silver...

  8. 15 CFR 996.10 - Submission and selection of hydrographic products for the development of standards and compliance...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The Quality Assurance Program for Hydrographic Products § 996.10 Submission and...

  9. 42 CFR 493.1495 - Standard; Testing personnel responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... samples are tested in the same manner as patient specimens; (3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

  10. Ohio Uses Wetlands Program Development Grants to Protect Wetlands

    EPA Pesticide Factsheets

    The wetland water quality standards require the use of ORAM score to determine wetland quality. OEPA has also used these tools to evaluate wetland mitigation projects, develop performance standards for wetland mitigation banks and In Lieu Fee programs an.

  11. Minimum Essential Requirements and Standards in Medical Education.

    ERIC Educational Resources Information Center

    Wojtczak, Andrzej; Schwarz, M. Roy

    2000-01-01

    Reviews the definition of standards in general, and proposes a definition of standards and global minimum essential requirements for use in medical education. Aims to serve as a tool for the improvement of quality and international comparisons of basic medical programs. Explains the IIME (Institute for International Medical Education) project…

  12. Policy Assessment for the Review of the Primary National Ambient Air Quality Standard for Sulfur Oxides, External Review Draft

    EPA Science Inventory

    Sulfur oxides are one of the six major air pollutants for which EPA has issued air quality criteria and established national ambient air quality standards (NAAQS) based on those criteria. The Clear Air Act (CAA) requires EPA to periodically review and revise, as appropriate, exis...

  13. 40 CFR 131.6 - Minimum requirements for water quality standards submission.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...)(2) and 303(c)(2) of the Act. (b) Methods used and analyses conducted to support water quality... scientific basis of the standards which do not include the uses specified in section 101(a)(2) of the Act as...

  14. 40 CFR 131.6 - Minimum requirements for water quality standards submission.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...)(2) and 303(c)(2) of the Act. (b) Methods used and analyses conducted to support water quality... scientific basis of the standards which do not include the uses specified in section 101(a)(2) of the Act as...

  15. 40 CFR 131.6 - Minimum requirements for water quality standards submission.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...)(2) and 303(c)(2) of the Act. (b) Methods used and analyses conducted to support water quality... scientific basis of the standards which do not include the uses specified in section 101(a)(2) of the Act as...

  16. 78 FR 50360 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Infrastructure SIP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... National Ambient Air Quality Standards; Indiana PSD; Indiana State Board Requirements AGENCY: Environmental... from Indiana addressing EPA's requirements for the prevention of significant deterioration (PSD... (PSD elements), or EPA-R05-OAR-2012-0988 (state board requirements), by one of the following methods: 1...

  17. 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.

  18. 76 FR 58835 - Information Collection Activity: Revision for Subpart C, Pollution Prevention and Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... provisions ``for compliance with the National Ambient Air Quality Standards [NAAQS] pursuant to the Clean Air... affect the air quality of any State.'' Section 1843(b) calls for ``regulations requiring all materials... State air quality requirement that was inadvertently submitted to OMB previously under 30 CFR 250...

  19. Child Development Functionality Assessment Guide: Standards and Requirements for Developing Most Efficient Organizations.

    ERIC Educational Resources Information Center

    Department of the Army, Washington, DC.

    As part of its cost containment efforts, the U.S. Navy continues to evaluate its child development program to expand availability without compromising the high quality standards required by the 1989 Military Child Care Act. This manual provides guidelines for conducting Functionality Assessments (FA) and delineates the standards and requirements…

  20. 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.

  1. IS0 9000 Implementation and Assessment: A Guide to Developing and Evaluating Quality Management Systems

    NASA Technical Reports Server (NTRS)

    Navarro, Robert J.; Grimm, Barry

    1996-01-01

    The agency has developed this reference publication to aid NASA organizations and their suppliers in the transition to IS0 9000. This guide focuses on the standard s intent, clarifies its requirements, offers implementation examples and highlights interrelated areas. It can assist anyone developing or evaluating NASA or supplier quality management systems. The IS0 9000 standards contain the basic elements for managing those processes that affect an organization's ability to consistently meet customer requirements. IS0 9000 was developed through the International Organization for Standardization and has been adopted as the US. national standard. These standards define a flexible foundation for customer focused process measurement, management and improvement that is the hallmark of world class enterprises.

  2. Framework for establishing records control in hospitals as an ISO 9001 requirement.

    PubMed

    Al-Qatawneh, Lina

    2017-02-13

    Purpose The purpose of this paper is to present the process followed to control records in a Jordanian private community hospital as an ISO 9001:2008 standard requirement. Design/methodology/approach Under the hospital quality council's supervision, the quality management and development office staff were responsible for designing, planning and implementing the quality management system (QMS) using the ISO 9001:2008 standard. A policy for records control was established. An action plan for establishing the records control was developed and implemented. On completion, a coding system for records was specified to be used by hospital staff. Finally, an internal audit was performed to verify conformity to the ISO 9001:2008 standard requirements. Findings Successful certification by a neutral body ascertained that the hospital's QMS conformed to the ISO 9001:2008 requirements. A framework was developed that describes the records controlling process, which can be used by staff in any healthcare organization wanting to achieve ISO 9001:2008 accreditation. Originality/value Given the increased interest among healthcare organizations to achieve the ISO 9001 certification, the proposed framework for establishing records control is developed and is expected to be a valuable management tool to improve and sustain healthcare quality.

  3. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical... stability and storage; (F) The skills required to implement the quality control policies and procedures of... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

  4. 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...

  5. Oromucosal film preparations: classification and characterization methods.

    PubMed

    Preis, Maren; Woertz, Christina; Kleinebudde, Peter; Breitkreutz, Jörg

    2013-09-01

    Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included. This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected. Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.

  6. An empirical evaluation of software quality assurance practices and challenges in a developing country: a comparison of Nigeria and Turkey.

    PubMed

    Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo

    2016-01-01

    The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.

  7. MODELING TOOLS USED FOR MERCURY TMDLS IN GEORGIA RIVERS

    EPA Science Inventory

    The Clean Water Act and associated regulations require each State to identify waters not meeting water quality standards applicable to their designated uses. Total maximum daily loads (TMDLs) are required for pollutants violating these standards. The Consent Decree in the Georg...

  8. Setting and Reviewing Standards to Control Particulate Matter (PM) Pollution

    EPA Pesticide Factsheets

    The Clean Air Act requires EPA to set national air quality standards for particulate matter, and to periodically review the standards to ensure that they provide adequate health and environmental protection, updating those standards as necessary.

  9. 77 FR 64425 - Approval and Promulgation of Implementation Plans; Alaska: Infrastructure Requirements for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... Ambient Air Quality Standard AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY... the National Ambient Air Quality Standards (NAAQS) promulgated for ozone on July 18, 1997. EPA finds... measuring and monitoring ozone in ambient air, a general definition of ozone, federal Prevention of...

  10. ISO 9000 and Higher Education: Can This Approach to Quality Work on Campus?

    ERIC Educational Resources Information Center

    Bennett, Charles

    1997-01-01

    The most widely recognized quality management standard in the world, the International Organization for Standardization's ISO 9000, is considered by some in higher education to have much potential for college administration. Its advantages include its focus on organizational infrastructure, adaptability, articulation of tangible requirements for…

  11. TEQSA and Risk-Based Regulation: Considerations for University Governing Bodies

    ERIC Educational Resources Information Center

    Baird, Jeanette

    2013-01-01

    The advent of a new national regulatory and quality assurance regime in Australia, through the Tertiary Education Quality and Standards Agency (TEQSA), presents additional requirements to university governing bodies, for compliance with standards and for risk management. This paper discusses TEQSA's approach and potential vulnerabilities for TEQSA…

  12. 15 CFR 996.20 - Submission of a hydrographic product for certification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a...) Upon adoption by NOAA of standards and compliance tests, any non-Federal entity may submit a...

  13. 15 CFR 996.20 - Submission of a hydrographic product for certification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a...) Upon adoption by NOAA of standards and compliance tests, any non-Federal entity may submit a...

  14. 15 CFR 996.20 - Submission of a hydrographic product for certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a...) Upon adoption by NOAA of standards and compliance tests, any non-Federal entity may submit a...

  15. 15 CFR 996.20 - Submission of a hydrographic product for certification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a...) Upon adoption by NOAA of standards and compliance tests, any non-Federal entity may submit a...

  16. 7 CFR 51.475 - U.S. Fancy.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... meet the requirements of U.S. No. 1 grade except that the cantaloups have very good internal quality... shall not apply to the requirements relating to internal quality and uniformity of appearance: (1) At... Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing...

  17. 24 CFR 982.401 - Housing quality standards (HQS).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Elevators must be working and safe. (h) Interior air quality—(1) Performance requirement. The dwelling unit... environment; (E) Illumination and electricity; (F) Structure and materials; (G) Interior air quality; (H... dwelling unit. (e) Thermal environment—(1) Performance requirement. The dwelling unit must have and be...

  18. 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...

  19. 40 CFR 80.1611 - Standards and requirements for certified ethanol denaturant.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... certified ethanol denaturant. 80.1611 Section 80.1611 Protection of Environment ENVIRONMENTAL PROTECTION....1611 Standards and requirements for certified ethanol denaturant. Producers and importers of ethanol denaturant that is suitable for the manufacture of denatured fuel ethanol (DFE) meeting federal quality...

  20. Setting and Reviewing Standards to Control SO2 Pollution

    EPA Pesticide Factsheets

    EPA sets National Ambient Air Quality Standards (NAAQS) for SO2 to protect public health (primary standard) and to protect public welfare (secondary standard). The Clean Air Act also requires EPA to periodically review and revise them if appropriate.

  1. Setting and Reviewing Standards to Control NO2 Pollution

    EPA Pesticide Factsheets

    EPA sets National Ambient Air Quality Standards (NAAQS) for NO2 to protect public health (primary standard) and to protect public welfare (secondary standard). The Clean Air Act also requires EPA to periodically review and revise them if appropriate.

  2. A standard for measuring metadata quality in spectral libraries

    NASA Astrophysics Data System (ADS)

    Rasaiah, B.; Jones, S. D.; Bellman, C.

    2013-12-01

    A standard for measuring metadata quality in spectral libraries Barbara Rasaiah, Simon Jones, Chris Bellman RMIT University Melbourne, Australia barbara.rasaiah@rmit.edu.au, simon.jones@rmit.edu.au, chris.bellman@rmit.edu.au ABSTRACT There is an urgent need within the international remote sensing community to establish a metadata standard for field spectroscopy that ensures high quality, interoperable metadata sets that can be archived and shared efficiently within Earth observation data sharing systems. Metadata are an important component in the cataloguing and analysis of in situ spectroscopy datasets because of their central role in identifying and quantifying the quality and reliability of spectral data and the products derived from them. This paper presents approaches to measuring metadata completeness and quality in spectral libraries to determine reliability, interoperability, and re-useability of a dataset. Explored are quality parameters that meet the unique requirements of in situ spectroscopy datasets, across many campaigns. Examined are the challenges presented by ensuring that data creators, owners, and data users ensure a high level of data integrity throughout the lifecycle of a dataset. Issues such as field measurement methods, instrument calibration, and data representativeness are investigated. The proposed metadata standard incorporates expert recommendations that include metadata protocols critical to all campaigns, and those that are restricted to campaigns for specific target measurements. The implication of semantics and syntax for a robust and flexible metadata standard are also considered. Approaches towards an operational and logistically viable implementation of a quality standard are discussed. This paper also proposes a way forward for adapting and enhancing current geospatial metadata standards to the unique requirements of field spectroscopy metadata quality. [0430] BIOGEOSCIENCES / Computational methods and data processing [0480] BIOGEOSCIENCES / Remote sensing [1904] INFORMATICS / Community standards [1912] INFORMATICS / Data management, preservation, rescue [1926] INFORMATICS / Geospatial [1930] INFORMATICS / Data and information governance [1946] INFORMATICS / Metadata [1952] INFORMATICS / Modeling [1976] INFORMATICS / Software tools and services [9810] GENERAL OR MISCELLANEOUS / New fields

  3. Dishwashing water recycling system and related water quality standards for military use.

    PubMed

    Church, Jared; Verbyla, Matthew E; Lee, Woo Hyoung; Randall, Andrew A; Amundsen, Ted J; Zastrow, Dustin J

    2015-10-01

    As the demand for reliable and safe water supplies increases, both water quality and available quantity are being challenged by population growth and climate change. Greywater reuse is becoming a common practice worldwide; however, in remote locations of limited water supply, such as those encountered in military installations, it is desirable to expand its classification to include dishwashing water to maximize the conservation of fresh water. Given that no standards for dishwashing greywater reuse by the military are currently available, the current study determined a specific set of water quality standards for dishwater recycling systems for U.S. military field operations. A tentative water reuse standard for dishwashing water was developed based on federal and state regulations and guidelines for non-potable water, and the developed standard was cross-evaluated by monitoring water quality data from a full-scale dishwashing water recycling system using an innovative electrocoagulation and ultrafiltration process. Quantitative microbial risk assessment (QMRA) was also performed based on exposure scenarios derived from literature data. As a result, a specific set of dishwashing water reuse standards for field analysis (simple, but accurate) was finalized as follows: turbidity (<1 NTU), Escherichia coli (<50 cfu mL(-1)), and pH (6-9). UV254 was recommended as a surrogate for organic contaminants (e.g., BOD5), but requires further calibration steps for validation. The developed specific water standard is the first for dishwashing water reuse and will be expected to ensure that water quality is safe for field operations, but not so stringent that design complexity, cost, and operational and maintenance requirements will not be feasible for field use. In addition the parameters can be monitored using simple equipment in a field setting with only modest training requirements and real-time or rapid sample turn-around. This standard may prove useful in future development of civilian guidelines. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Total quality assurance

    NASA Astrophysics Data System (ADS)

    Louzon, E.

    1989-12-01

    Quality, cost, and schedule are three factors affecting the competitiveness of a company; they require balancing so that products of acceptable quality are delivered, on time and at a competitive cost. Quality costs comprise investment in quality maintenance and failure costs which arise from failure to maintain standards. The basic principle for achieving the required quality at minimum cost is that of prevention of failures, etc., through production control, attention to manufacturing practices, and appropriate management and training. Total quality control involves attention to the product throughout its life cycle, including in-service performance evaluation, servicing, and maintenance.

  5. Quality control and improvement of cancer care: what is needed? 4th European Roundtable Meeting (ERTM) May 5th, 2017, Berlin, Germany.

    PubMed

    Ortmann, Olaf; Helbig, Ulrike; Torode, Julie; Schreck, Stefan; Karjalainen, Sakari; Bettio, Manola; Ringborg, Ulrik; Klinkhammer-Schalke, Monika; Bray, Freddy

    2018-06-01

    National Cancer Control Plans (NCCPs) often describe structural requirements for high quality cancer care. During the fourth European Roundtable Meeting (ERTM) participants shared learnings from their own national setting to formulate best practice in optimizing communication strategies between parties involved in clinical cancer registries, cancer centers and guideline groups. A decentralized model of data collection close to the patient and caregiver enhances timely completion and the quality of the data captured. Nevertheless, central coordination is necessary to define datasets, indicators, standard settings, education, training and quality control to maintain standards across the network. In particular, interaction of parties in cancer care network has to be established and maintained on a regular basis. After establishing the structural requirements of cancer care networks, communication between the different components and parties is required to analyze outcome data, provide regular reporting to all and develop strategies for continuous improvement of quality across the network.

  6. Establishment of National Laboratory Standards in Public and Private Hospital Laboratories

    PubMed Central

    ANJARANI, Soghra; SAFADEL, Nooshafarin; DAHIM, Parisa; AMINI, Rana; MAHDAVI, Saeed; MIRAB SAMIEE, Siamak

    2013-01-01

    In September 2007 national standard manual was finalized and officially announced as the minimal quality requirements for all medical laboratories in the country. Apart from auditing laboratories, Reference Health Laboratory has performed benchmarking auditing of medical laboratory network (surveys) in provinces. 12th benchmarks performed in Tehran and Alborz provinces, Iran in 2010 in three stages. We tried to compare different processes, their quality and accordance with national standard measures between public and private hospital laboratories. The assessment tool was a standardized checklist consists of 164 questions. Analyzing process show although in most cases implementing the standard requirements are more prominent in private laboratories, there is still a long way to complete fulfillment of requirements, and it takes a lot of effort. Differences between laboratories in public and private sectors especially in laboratory personnel and management process are significant. Probably lack of motivation, plays a key role in obtaining less desirable results in laboratories in public sectors. PMID:23514840

  7. Air Quality Criteria for Lead (Final Report, 2006)

    EPA Science Inventory

    National Ambient Air Quality Standards (NAAQS) are promulgated by the United States Environmental Protection Agency (EPA) to meet requirements set forth in Sections 108 and 109 of the U.S. Clean Air Act. Those two Clean Air Act sections require the EPA Administrator (1) to list w...

  8. Analytical quality goals derived from the total deviation from patients' homeostatic set points, with a margin for analytical errors.

    PubMed

    Bolann, B J; Asberg, A

    2004-01-01

    The deviation of test results from patients' homeostatic set points in steady-state conditions may complicate interpretation of the results and the comparison of results with clinical decision limits. In this study the total deviation from the homeostatic set point is defined as the maximum absolute deviation for 95% of measurements, and we present analytical quality requirements that prevent analytical error from increasing this deviation to more than about 12% above the value caused by biology alone. These quality requirements are: 1) The stable systematic error should be approximately 0, and 2) a systematic error that will be detected by the control program with 90% probability, should not be larger than half the value of the combined analytical and intra-individual standard deviation. As a result, when the most common control rules are used, the analytical standard deviation may be up to 0.15 times the intra-individual standard deviation. Analytical improvements beyond these requirements have little impact on the interpretability of measurement results.

  9. 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...

  10. White Sands Missile Range 2011 Drinking Water Quality Report

    DTIC Science & Technology

    2012-01-01

    This Annual Drinking Water Quality Report, or the Consumer Confi dence Report, is required by the Safe Drinking Water Act (SDWA). The SDWA ensures...public drinking water systems meet national standards for the protection of your health. This report provides details about where your water comes...NMED). WSMR tap water meets all EPA and NMED drinking water standards. What is This Water Quality Report? Este informe contiene informacion importante

  11. The Legislative Requirements for Measuring Quality in Transnational Education: Understanding Divergence While Maintaining Standards

    ERIC Educational Resources Information Center

    Bentley, Duncan; Henderson, Fiona; Lim, Choon Boey

    2017-01-01

    Australian universities have been actively engaged in transnational education since the 1990s. The challenges of assuring quality have seen a changing regulatory framework increasingly designed to ensure equivalence of standards wherever a course of study is offered and however it is delivered. Transnational Higher Education has grown…

  12. 78 FR 50358 - Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule, Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... proposed action may significantly affect the quality of the human environment (21 CFR 25.22(b)) and... response to a microbial standard, may significantly affect the quality of the human environment. Similarly, comments received caused FDA to reevaluate the proposed requirements for biological soil amendments of...

  13. 40 CFR 121.25 - Adoption of new water quality standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Adoption of new water quality standards. 121.25 Section 121.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS STATE CERTIFICATION OF ACTIVITIES REQUIRING A FEDERAL LICENSE OR PERMIT Certification by the Administrator § 121.25 Adoption of new water...

  14. 40 CFR 121.25 - Adoption of new water quality standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Adoption of new water quality standards. 121.25 Section 121.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS STATE CERTIFICATION OF ACTIVITIES REQUIRING A FEDERAL LICENSE OR PERMIT Certification by the Administrator § 121.25 Adoption of new water...

  15. 42 CFR 493.1231 - Standard: Confidentiality of patient information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

  16. 42 CFR 493.1231 - Standard: Confidentiality of patient information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

  17. 42 CFR 493.1231 - Standard: Confidentiality of patient information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

  18. 42 CFR 493.1231 - Standard: Confidentiality of patient information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

  19. [Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control].

    PubMed

    Dong, Ling; Sun, Yu; Pei, Wen-Xuan; Dai, Jun-Dong; Wang, Zi-Yu; Pan, Meng; Chen, Jiang-Peng; Wang, Yun

    2017-12-01

    The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry. Copyright© by the Chinese Pharmaceutical Association.

  20. Impact of proposed Washington State water quality standards on Hanford

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

    Corley, J.P.; Selby, J.M.

    1967-11-03

    The proposed regulation relating to Water Quality Standards for Interstate and Coastal Waters of the State of Washington contains eight standards. Standards are established for Total Coliform Organisms, Dissolved Oxygen, Temperature, Radioactivity, pH, Turbidity, Toxic or Deleterious Material, and Aesthetic Values. The Columbia River from the Washington-Oregon border to Priest Rapids is designated as class A water. Additionally, special temperature requirements are defined for this reach of the river. This report reviews the measured and projected conditions in this reach of the river in relation to these standards. 4 figs.

  1. Microfilm Standards. Counties, Municipalities, School Districts.

    ERIC Educational Resources Information Center

    New Jersey State Dept. of Education, Trenton.

    This pamphlet contains the standards and requirements approved by the New Jersey State Records Committee on May 13, 1981, which bring the microfilm quality-control standards into conformity with national standards. Standards and guidelines are established for the selection of records to be microfilmed, the selection of equipment and vendors, the…

  2. Consistency Across Standards or Standards in a New Business Model

    NASA Technical Reports Server (NTRS)

    Russo, Dane M.

    2010-01-01

    Presentation topics include: standards in a changing business model, the new National Space Policy is driving change, a new paradigm for human spaceflight, consistency across standards, the purpose of standards, danger of over-prescriptive standards, a balance is needed (between prescriptive and general standards), enabling versus inhibiting, characteristics of success-oriented standards, characteristics of success-oriented standards, and conclusions. Additional slides include NASA Procedural Requirements 8705.2B identifies human rating standards and requirements, draft health and medical standards for human rating, what's been done, government oversight models, examples of consistency from anthropometry, examples of inconsistency from air quality and appendices of government and non-governmental human factors standards.

  3. 15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The... a hydrographic product or class. (a) NOAA shall work, to the extent practicable, through existing...

  4. 15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The... a hydrographic product or class. (a) NOAA shall work, to the extent practicable, through existing...

  5. 15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The... a hydrographic product or class. (a) NOAA shall work, to the extent practicable, through existing...

  6. 15 CFR 996.12 - Development of standards compliance tests for a hydrographic product or class.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES The... a hydrographic product or class. (a) NOAA shall work, to the extent practicable, through existing...

  7. A Functional Model of Quality Assurance for Psychiatric Hospitals and Corresponding Staffing Requirements.

    ERIC Educational Resources Information Center

    Kamis-Gould, Edna; And Others

    1991-01-01

    A model for quality assurance (QA) in psychiatric hospitals is described. Its functions (general QA, utilization review, clinical records, evaluation, management information systems, risk management, and infection control), subfunctions, and corresponding staffing requirements are reviewed. This model was designed to foster standardization in QA…

  8. 48 CFR 46.203 - Criteria for use of contract quality requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Criteria for use of contract quality requirements. 46.203 Section 46.203 Federal Acquisition Regulations System FEDERAL...) Commercial (described in commercial catalogs, drawings, or industrial standards; see part 2); or (2) Military...

  9. 48 CFR 46.203 - Criteria for use of contract quality requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Criteria for use of contract quality requirements. 46.203 Section 46.203 Federal Acquisition Regulations System FEDERAL...) Commercial (described in commercial catalogs, drawings, or industrial standards; see part 2); or (2) Military...

  10. 48 CFR 46.203 - Criteria for use of contract quality requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Criteria for use of contract quality requirements. 46.203 Section 46.203 Federal Acquisition Regulations System FEDERAL...) Commercial (described in commercial catalogs, drawings, or industrial standards; see part 2); or (2) Military...

  11. 48 CFR 46.203 - Criteria for use of contract quality requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Criteria for use of contract quality requirements. 46.203 Section 46.203 Federal Acquisition Regulations System FEDERAL...) Commercial (described in commercial catalogs, drawings, or industrial standards; see part 2); or (2) Military...

  12. 48 CFR 46.203 - Criteria for use of contract quality requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Criteria for use of contract quality requirements. 46.203 Section 46.203 Federal Acquisition Regulations System FEDERAL...) Commercial (described in commercial catalogs, drawings, or industrial standards; see part 2); or (2) Military...

  13. 42 CFR 422.504 - Contract provisions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... recognized standards of health care, all benefits covered by Medicare. (4) To disclose information to beneficiaries in the manner and the form prescribed by CMS as required under § 422.111; (5) To operate a quality assurance and performance improvement program and have an agreement for external quality review as required...

  14. Level of structural quality and process quality in rural preschool classrooms

    PubMed Central

    Hartman, Suzanne C.; Warash, Barbara G.; Curtis, Reagan; Hirst, Jessica Day

    2017-01-01

    Preschool classrooms with varying levels of structural quality requirements across the state of West Virginia were investigated for differences in measured structural and process quality. Quality was measured using group size, child-to-teacher/staff ratio, teacher education, and the Early Childhood Environmental Rating Scale-Revised (ECERS-R; Harms, T., Clifford, R. M., & Cryer, D. (2005). The early childhood environment rating scale-revised. New York, NY: Teachers College Press). Thirty-six classrooms with less structural quality requirements and 136 with more structural quality requirements were measured. There were significant differences between classroom type, with classrooms with more structural quality requirements having significantly higher teacher education levels and higher environmental rating scores on the ECERS-R subscales of Space and Furnishings, Activities, and Program Structure. Results support previous research that stricter structural state regulations are correlated with higher measured structural and process quality in preschool classrooms. Implications for preschool state quality standards are discussed. PMID:29056814

  15. Guidance on Developing Fee Programs Required by Clean Air Act Section 185 for the 1997 1-hour Ozone National Ambient Air Quality Standards (NAAQS)

    EPA Pesticide Factsheets

    This January 2010 memorandum provides additional guidance on fee collection programs for the 1997 1-hour ozone NAAQS, which are required as anti-backsliding measures during transition to the 1997 8-hour ozone standard.

  16. 40 CFR 51.918 - Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? 51.918... 8-hour Ozone National Ambient Air Quality Standard § 51.918 Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? Upon a...

  17. 40 CFR 51.918 - Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? 51.918... 8-hour Ozone National Ambient Air Quality Standard § 51.918 Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? Upon a...

  18. 45 CFR 156.1105 - Establishment of standards for HHS-approved enrollee satisfaction survey vendors for use by QHP...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Welfare Department of Health and Human Services REQUIREMENTS RELATING TO HEALTH CARE ACCESS HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES Quality...

  19. Analysis of DoD Usage of Multimedia Technology to Determine Requirements for Standards.

    DTIC Science & Technology

    1995-03-01

    1995 Accesion For NTIS CRA&I DTlC TAB Unannounced Justification By._ _ Distribution/ i D D Availability Codes Dist A-/ Avail...developing a standard architecture for their multimedia systems. When the DoD participants were asked to identify areas where standards are lack...are limited, they will sacrifice vid- eo quality in order to sustain audio quality. In order for desktop conferencing to become a market success

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

    PubMed

    Summers, Angela E

    2006-03-17

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

  1. Clinical laboratory accreditation in India.

    PubMed

    Handoo, Anil; Sood, Swaroop Krishan

    2012-06-01

    Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

  2. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

  3. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

  4. 78 FR 42482 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

    ... Promulgation of Air Quality Implementation Plans; Pennsylvania; Infrastructure Requirements for the 2008 Lead National Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule... Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg...

  5. 78 FR 52893 - Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 50, 51, 70 and 71 [EPA-HQ-OAR-2010-0885, FRL-9810-3] RIN 2060-AR34 Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements Correction In proposed rule document 2013-13233 appearing on pages 34178 through...

  6. 76 FR 9655 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    ... exempt sources of Oxides of Nitrogen (NO X ) in the Illinois portions of the Chicago-Gary-Lake County...) requirements for NO X Reasonably Available Control Technology (RACT) for purposes of attaining the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS or standard). This NO X RACT waiver is based on the...

  7. A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

    PubMed

    Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

    2017-03-01

    Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

  8. Quality assurance in military medical research and medical radiation accident management.

    PubMed

    Hotz, Mark E; Meineke, Viktor

    2012-08-01

    The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within the scope of external quality assurance, but also in the exchange of special diagnosis data among international research networks. In summary, the acknowledged standard for a quality management system to ensure quality assurance is the very generic standard ISO 9001.Health Phys. 103(2):221-225; 2012.

  9. Manufacture and quality control of interconnecting wire hardnesses, Volume 1

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A standard is presented for manufacture, installation, and quality control of eight types of interconnecting wire harnesses. The processes, process controls, and inspection and test requirements reflected are based on acknowledgment of harness design requirements, acknowledgment of harness installation requirements, identification of the various parts, materials, etc., utilized in harness manufacture, and formulation of a typical manufacturing flow diagram for identification of each manufacturing and quality control process, operation, inspection, and test. The document covers interconnecting wire harnesses defined in the design standard, including type 1, enclosed in fluorocarbon elastomer convolute, tubing; type 2, enclosed in TFE convolute tubing lines with fiberglass braid; type 3, enclosed in TFE convolute tubing; and type 5, combination of types 3 and 4. Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated.

  10. 48 CFR 970.1100-1 - Performance-based contracting.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... methods of accomplishing the work; use measurable (i.e., terms of quality, timeliness, quantity) performance standards and objectives and quality assurance surveillance plans; provide performance incentives... work and other documents used to establish work requirements. (d) Quality assurance surveillance plans...

  11. 48 CFR 970.1100-1 - Performance-based contracting.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... methods of accomplishing the work; use measurable (i.e., terms of quality, timeliness, quantity) performance standards and objectives and quality assurance surveillance plans; provide performance incentives... work and other documents used to establish work requirements. (d) Quality assurance surveillance plans...

  12. 48 CFR 970.1100-1 - Performance-based contracting.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... methods of accomplishing the work; use measurable (i.e., terms of quality, timeliness, quantity) performance standards and objectives and quality assurance surveillance plans; provide performance incentives... work and other documents used to establish work requirements. (d) Quality assurance surveillance plans...

  13. 77 FR 28423 - Final Rule To Implement the 1997 8-Hour Ozone National Ambient Air Quality Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ...The EPA is revising the rules for implementing the 1997 8-hour ozone national ambient air quality standards (NAAQS) to address certain limited portions of the rules vacated by the U.S. Court of Appeals for the District of Columbia Circuit. This final rule assigns Clean Air Act (CAA or Act) classifications and associated state planning and control requirements to selected ozone nonattainment areas. This final rule also addresses three vacated provisions of the 1997 8-hour NAAQS--Phase 1 Implementation Rule (April 30, 2004) that provided exemptions from the anti-backsliding requirements relating to nonattainment area New Source Review (NSR), CAA section 185 penalty fees, and contingency measures, as these three requirements applied for the 1-hour standard. This rule also reinstates the 1-hour contingency measures as applicable requirements that must be retained until the area attains the 1997 8- hour ozone standard. Finally, this rule deletes an obsolete provision that stayed the EPA's authority to revoke the 1-hour ozone standard pending the Agency's issuance of a final rule that revises or reinstates its revocation authority and considers and addresses certain other issues. That rule has now been issued.

  14. 42 CFR 493.1232 - Standard: Specimen identification and integrity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1232 Standard: Specimen identification and integrity. The laboratory must establish and follow written policies and procedures that ensure positive identification and...

  15. 42 CFR 493.1233 - Standard: Complaint investigations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1233 Standard: Complaint investigations. The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory...

  16. Does Teacher Testing Raise Teacher Quality? Evidence from State Certification Requirements

    ERIC Educational Resources Information Center

    Angrist, Joshua D.; Guryan, Jonathan

    2008-01-01

    The education reform movement includes efforts to raise teacher quality through stricter certification and licensing provisions. Most US states now require public school teachers to pass a standardized test such as the Praxis. Although any barrier to entry is likely to raise wages in the affected occupation, the theoretical effects of such…

  17. 78 FR 63437 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... the 2010 Sulfur Dioxide National Ambient Air Quality Standards AGENCY: Environmental Protection Agency... requirements for the 2010 sulfur dioxide (SO 2 ) NAAQS. This action proposes to approve portions of this... and unless it is reversed or otherwise modified by the Supreme Court, states are not required to...

  18. Competency-Based Education: A Framework for Measuring Quality Courses

    ERIC Educational Resources Information Center

    Krause, Jackie; Dias, Laura Portolese; Schedler, Chris

    2015-01-01

    The growth of competency-based education in an online environment requires the development and measurement of quality competency-based courses. While quality measures for online courses have been developed and standardized, they do not directly align with emerging best practices and principles in the design of quality competency-based online…

  19. 14 CFR 21.607 - Quality system.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Quality system. 21.607 Section 21.607... PROCEDURES FOR PRODUCTS AND PARTS Technical Standard Order Approvals § 21.607 Quality system. Each applicant for or holder of a TSO authorization must establish a quality system that meets the requirements of...

  20. RAPIDLY MEASURED INDICATORS OF RECREATIONAL WATER QUALITY ARE PREDICTIVE OF SWIMMING ASSOCIATED GASTROINTESTINAL ILLNESS

    EPA Science Inventory

    Standard methods to measure recreational water quality require at least 24 hours to obtain results making it impossible to assess the quality of water within a single day. Methods to measure recreational water quality in two hours or less have been developed. Application of rapid...

  1. CAN RAPID MEASURES OF RECREATIONAL WATER QUALITY PREDICT SWIMMING ASSOCIATED GASTROINTESTINAL ILLNESS?

    EPA Science Inventory

    Standard methods to measure recreational water quality require at least 24 hours to obtain results making it impossible to assess the quality of water within a single day. Methods to measure recreational water quality in two hours or less have been developed. Application of rapid...

  2. 42 CFR 493.1241 - Standard: Test request.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Preanalytic Systems § 493.1241 Standard: Test request...

  3. 42 CFR 493.1283 - Standard: Test records.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test records. 493.1283 Section 493.1283 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (...

  4. 42 CFR 493.1291 - Standard: Test report.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test report. 493.1291 Section 493.1291 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Postanalytic Systems § 493.1291 Standard: Test report....

  5. Dietary supplements quality analysis tools from the United States Pharmacopeia.

    PubMed

    Sarma, Nandakumara; Giancaspro, Gabriel; Venema, Jaap

    2016-01-01

    The United States Food and Drug Administration (FDA) issued the dietary supplement (DS) current good manufacturing practice (GMP) regulations in compliance with the mandate from the Dietary Supplements Health and Education Act (DSHEA), with the intention of protecting public health by ensuring the quality of DS. The GMP regulations require manufacturers to establish their own quality specifications for identity, purity, strength, composition, and absence of contaminants. Numerous FDA-conducted GMP inspections found that the private specifications set by these manufacturers are often insufficient to ensure adequate quality of dietary ingredients and DS. Wider use of the public standards developed by the United States Pharmacopeial Convention (USP), in conjunction with GMP compliance, can help ensure quality and consistency of DS as they do for medicines. Public health protection could be enhanced by strengthening the GMP provisions to require conformance with relevant United States Pharmacopeia-National Formulary (USP-NF) standards, or in the absence of USP standards, other public compendial standards. Another serious concern is the presence of synthetic drugs and drug analogues in products marketed as DS. Use of the new USP General Chapter Adulteration of Dietary Supplements with Drugs and Drug Analogs <2251> may reduce the exposure of consumers to dangerous drugs disguised as DS. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  6. Current status and standards for establishment of hemodialysis units in Korea

    PubMed Central

    Lee, Young-Ki; Kim, Kiwon

    2013-01-01

    The number of hemodialysis patients and dialysis facilities is increasing each year, but there are no surveillance programs validating that the services and equipment of each hemodialysis unit meet specified safety and quality standards. There is a concern that excessive competition and illegal activities committed by some dialysis facilities may violate patients' right to health. Contrastingly, developed countries often have their own survey program to provide initial certification and monitoring to ensure that these clinics continue to meet basic requirements. Because hemodialysis units provide renal replacement therapy to critical patients suffering from severe chronic renal failure, appropriate legal regulation is important for the provision of initial certification and maintenance of facility, equipment, and human resource quality. Therefore, several standards providing minimum requirements for the area of hemodialysis unit, equipment for emergency care, physician and nurse staffs, water purification and quality management are urgently needed. PMID:23682218

  7. [Standardization of cancer biobank in precision medicine era].

    PubMed

    Ji, Jiafu

    2016-05-25

    Tumor specimens have a great role in basic and clinical translational researches on cancer, especially in the era of precision medicine. Thus the standardization of cancer biobank is of high importance. The establishment and maintenance of cancer biobank require comprehensive quality management, so as to provide high quality service for basic and clinical researches. At present, sample-oriented collection and management, and clinical and pathological data annotation are the main focuses of biobank standardization in China.

  8. Testing and validation of computerized decision support systems.

    PubMed

    Sailors, R M; East, T D; Wallace, C J; Carlson, D A; Franklin, M A; Heermann, L K; Kinder, A T; Bradshaw, R L; Randolph, A G; Morris, A H

    1996-01-01

    Systematic, through testing of decision support systems (DSSs) prior to release to general users is a critical aspect of high quality software design. Omission of this step may lead to the dangerous, and potentially fatal, condition of relying on a system with outputs of uncertain quality. Thorough testing requires a great deal of effort and is a difficult job because tools necessary to facilitate testing are not well developed. Testing is a job ill-suited to humans because it requires tireless attention to a large number of details. For these reasons, the majority of DSSs available are probably not well tested prior to release. We have successfully implemented a software design and testing plan which has helped us meet our goal of continuously improving the quality of our DSS software prior to release. While requiring large amounts of effort, we feel that the process of documenting and standardizing our testing methods are important steps toward meeting recognized national and international quality standards. Our testing methodology includes both functional and structural testing and requires input from all levels of development. Our system does not focus solely on meeting design requirements but also addresses the robustness of the system and the completeness of testing.

  9. Software Formal Inspections Standard

    NASA Technical Reports Server (NTRS)

    1993-01-01

    This Software Formal Inspections Standard (hereinafter referred to as Standard) is applicable to NASA software. This Standard defines the requirements that shall be fulfilled by the software formal inspections process whenever this process is specified for NASA software. The objective of this Standard is to define the requirements for a process that inspects software products to detect and eliminate defects as early as possible in the software life cycle. The process also provides for the collection and analysis of inspection data to improve the inspection process as well as the quality of the software.

  10. WATER QUALITY CRITERIA DOCUMENTS

    EPA Science Inventory

    Background

    Water quality standards and criteria are the foundation for a wide range of programs under the Clean Water Act. Specifically, under section 304(a)(1) of the Clean Water Act it requires EPA to develop criteria for water quality that accurately re...

  11. 78 FR 13835 - Harmonization of Airworthiness Standards-Miscellaneous Structures Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-01

    ... requirements for critical and non-critical castings; add control system requirements that consider structural... of critical casting and Quality control, inspection, and testing requirements for critical and non... control, inspection, and testing requirements for critical and non-critical castings. The proposed rule...

  12. 42 CFR 493.1241 - Standard: Test request.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing...

  13. 42 CFR 493.1241 - Standard: Test request.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing...

  14. 42 CFR 493.1283 - Standard: Test records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (a) The laboratory must maintain an information or record system that includes the following: (1) The positive identification of the specimen. (2) The date and...

  15. MUSQA: a CS method to build a multi-standard quality management system

    NASA Astrophysics Data System (ADS)

    Cros, Elizabeth; Sneed, Isabelle

    2002-07-01

    CS Communication & Systèmes, through its long quality management experience, has been able to build and evolve its Quality Management System according to clients requirements, norms, standards and models (ISO, DO178, ECSS, CMM, ...), evolving norms (transition from ISO 9001:1994 to ISO 9001:2000) and the TQM approach, being currently deployed. The aim of this paper is to show how, from this enriching and instructive experience, CS has defined and formalised its method: MuSQA (Multi-Standard Quality Approach). This method allows to built a new Quality Management System or simplify and unify an existing one. MuSQA objective is to provide any organisation with an open Quality Management System, which is able to evolve easily and turns to be a useful instrument for everyone, operational as well as non-operational staff.

  16. Ensuring quality and safety.

    PubMed

    Reid, Jerry

    2010-01-01

    The certification model addresses quality and safety by directly targeting the qualifications of individuals. The practice accreditation model takes a more global approach to quality and safety and addresses the qualifications of individuals and standards for additional components of the quality chain. Although both certification and practice accreditation fundamentally are voluntary, the programs may become mandatory when enforcement mechanisms are linked to the programs via state or federal legislation or via private reimbursement policies, effectively resulting in mandatory standards. The CARE bill takes a certification approach to quality and safety by focusing on the qualifications of the individual. MIPPA takes an accreditation approach by focusing on the practice. MQSA is somewhat of a hybrid in that it takes an accreditation approach, but spells out standards for the individual that the accreditor must follow. If the practice accreditation standards require that all technologists employed in the practice be certified in the modalities performed, then the practice accreditation model and the certification model become functionally equivalent in terms of personnel qualifications. To the extent that practice accreditation models are less prescriptive regarding personnel standards, the certification model results in more stringent standards.

  17. Model for selecting quality standards for a salad bar through identifying elements of customer satisfaction.

    PubMed

    Ouellet, D; Norback, J P

    1993-11-01

    Continuous quality improvement is the new requirement of the Joint Commission on Accreditation of Healthcare Organizations. This means that meeting quality standards will not be enough. Dietitians will need to improve those standards and the way they are selected. Because quality is defined in terms of the customers, all quality improvement projects must start by defining what customers want. Using a salad bar as an example, this article presents and illustrates a technique developed in Japan to identify which elements in a product or service will satisfy or dissatisfy consumers. Using a model and a questionnaire format developed by Kano and coworkers, 273 students were surveyed to classify six quality elements of a salad bar. Four elements showed a dominant "must-be" characteristic: food freshness, labeling of the dressings, no spills in the food, and no spills on the salad bar. The two other elements (food easy to reach and food variety) showed a dominant one-dimensional characteristic. By better understanding consumer perceptions of quality elements, foodservice managers can select quality standards that focus on what really matters to their consumers.

  18. [How to establish a good acupuncture-moxibustion standard?].

    PubMed

    Wu, Xiao-dong; Xiao, Hui

    2014-10-01

    At the beginning of a standard item, the standardized objects and involved contents should be demonstrated thoroughly, which is the precondition of establishing a good standard. After the proposal of this standard, a high-level drafting group should be built, led by top specialists who also draft the standard, which is essential to guarantee the quality of the standard. Before drafting the standard, literature regarding this standard should be searched completely, and Directives for Standardization should be learned to understand the basic requirements of establishing a standard; in the meanwhile, selections on standardized contents and quantitative boundaries of technical indices should be comprehensively and deeply studied. At the stage of consultation, focus should be paid on the scope of the consultation departments, level and personnel quality. As for standard review, it should be precise and truth-seeking. At the stage of submitting and authorization, it is necessary to have timely communication. Only by full cooperations of all parties, and by strictly following the procedure, method and rule of standard establishment, can a high-quality acupuncture-moxibustion standard be established.

  19. Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

    PubMed

    Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

    2016-12-01

    Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  20. Analysis of Indoor Environment in Classroom Based on Hygienic Requirements

    NASA Astrophysics Data System (ADS)

    Javorček, Miroslav; Sternová, Zuzana

    2016-06-01

    The article contains the analysis of experimental ventilation measurement in selected classrooms of the Elementary School Štrba. Mathematical model of selected classroom was prepared according to in-situ measurements and air exchange was calculated. Interior air temperature and quality influences the students ´ comfort. Evaluated data were compared to requirements of standard (STN EN 15251,2008) applicable to classroom indoor environment during lectures, highlighting the difference between required ambiance quality and actually measured values. CO2 concentration refers to one of the parameters indicating indoor environment quality.

  1. Is Your Biobank Up to Standards? A Review of the National Canadian Tissue Repository Network Required Operational Practice Standards and the Controlled Documents of a Certified Biobank.

    PubMed

    Hartman, Victoria; Castillo-Pelayo, Tania; Babinszky, Sindy; Dee, Simon; Leblanc, Jodi; Matzke, Lise; O'Donoghue, Sheila; Carpenter, Jane; Carter, Candace; Rush, Amanda; Byrne, Jennifer; Barnes, Rebecca; Mes-Messons, Anne-Marie; Watson, Peter

    2018-02-01

    Ongoing quality management is an essential part of biobank operations and the creation of high quality biospecimen resources. Adhering to the standards of a national biobanking network is a way to reduce variability between individual biobank processes, resulting in cross biobank compatibility and more consistent support for health researchers. The Canadian Tissue Repository Network (CTRNet) implemented a set of required operational practices (ROPs) in 2011 and these serve as the standards and basis for the CTRNet biobank certification program. A review of these 13 ROPs covering 314 directives was conducted after 5 years to identify areas for revision and update, leading to changes to 7/314 directives (2.3%). A review of all internal controlled documents (including policies, standard operating procedures and guides, and forms for actions and processes) used by the BC Cancer Agency's Tumor Tissue Repository (BCCA-TTR) to conform to these ROPs was then conducted. Changes were made to 20/106 (19%) of BCCA-TTR documents. We conclude that a substantial fraction of internal controlled documents require updates at regular intervals to accommodate changes in best practices. Reviewing documentation is an essential aspect of keeping up to date with best practices and ensuring the quality of biospecimens and data managed by biobanks.

  2. AIR QUALITY CRITERIA FOR OZONE AND RELATED PHOTOCHEMICAL OXIDANTS

    EPA Science Inventory

    The Clean Air Act requires periodic (5-year) update revision of criteria and National Ambient Air Quality Standards (NAAQS) for Ozone. The previous revision of the criteria contained in the Air Quality Criteria Document (AQCD) for Ozone and Related Photochemical Oxidants was co...

  3. Clean air through transportation : challenges in meeting national air quality standards

    DOT National Transportation Integrated Search

    1993-08-01

    This report, required by Section 108(f)(3) of the Clean Air Act, as amended in 1990, addresses the issues of motor vehicles and air quality. The report discusses the challenges faced in attempting to improve air quality through transportation program...

  4. Common Core State Standards for English Language Arts & Literacy in History/Social Studies, Science, and Technical Subjects. Appendix B: Text Exemplars and Sample Performance Tasks

    ERIC Educational Resources Information Center

    Common Core State Standards Initiative, 2010

    2010-01-01

    The text samples presented in this document primarily serve to exemplify the level of complexity and quality that the Standards require all students in a given grade band to engage with. Additionally, they are suggestive of the breadth of texts that students should encounter in the text types required by the Standards. The choices should serve as…

  5. 40 CFR 51.918 - Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? 51.918 Section 51.918 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... 8-hour Ozone National Ambient Air Quality Standard § 51.918 Can any SIP planning requirements be...

  6. 40 CFR 51.918 - Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? 51.918 Section 51.918 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... 8-hour Ozone National Ambient Air Quality Standard § 51.918 Can any SIP planning requirements be...

  7. 40 CFR 51.918 - Can any SIP planning requirements be suspended in 8-hour ozone nonattainment areas that have air...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... suspended in 8-hour ozone nonattainment areas that have air quality data that meets the NAAQS? 51.918 Section 51.918 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... 8-hour Ozone National Ambient Air Quality Standard § 51.918 Can any SIP planning requirements be...

  8. HOW PROBABILITY SURVEY DATA CAN HELP INTEGRATE 305(B) AND 303(D MONITORING AND ASSESSMENT OF STATE WATERS

    EPA Science Inventory

    Section 305(b) of the Clean Water Act requires states to assess the overall quality of waters in the states, while Section 303(d) requires states to develop a list of the specific waters in their state not attaining water quality standards (a.k.a impaired waters). An integrate...

  9. 75 FR 76332 - Approval and Promulgation of Air Quality Implementation Plans; Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... Promulgation of Air Quality Implementation Plans; Illinois AGENCY: Environmental Protection Agency (EPA... attaining the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS). The State's NO X RACT waiver... classification of an area. The air quality planning and control requirements for the reduction of NO X emissions...

  10. 42 CFR 493.1254 - Standard: Maintenance and function checks.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Maintenance and function checks. 493.1254 Section 493.1254 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived...

  11. 42 CFR 493.1242 - Standard: Specimen submission, handling, and referral.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Specimen submission, handling, and referral. 493.1242 Section 493.1242 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System...

  12. 34 CFR 602.16 - Accreditation and preaccreditation standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Criteria for Recognition Required Standards and Their Application § 602.16 Accreditation and... quality of the institution or program in the following areas: (i) Success with respect to student...) An institution from developing and using institutional standards to show its success with respect to...

  13. 42 CFR 493.1234 - Standard: Communications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1234 Standard: Communications. The laboratory must have a system in place to... laboratory and an authorized person who orders or receives test results. [68 FR 3703, Jan. 24, 2003; 68 FR...

  14. Implementing Model-Check for Employee and Management Satisfaction

    NASA Technical Reports Server (NTRS)

    Jones, Corey; LaPha, Steven

    2013-01-01

    This presentation will discuss methods to which ModelCheck can be implemented to not only improve model quality, but also satisfy both employees and management through different sets of quality checks. This approach allows a standard set of modeling practices to be upheld throughout a company, with minimal interaction required by the end user. The presenter will demonstrate how to create multiple ModelCheck standards, preventing users from evading the system, and how it can improve the quality of drawings and models.

  15. Los Alamos National Laboratory Meteorology Monitoring Program: 2016 Data Completeness/ Quality Report

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

    Bruggeman, David Alan

    This report summarizes data completeness by tower and by instrument for 2016 and compares that data with the Los Alamos National Laboratory (LANL) and American National Standards Institute (ANSI) 2015 standards. This report is designed to make data users aware of data completeness and any data quality issues. LANL meteorology monitoring goals include 95% completeness for all measurements. The ANSI 2015 standard requires 90% completeness for all measurements. This report documents instrument/tower issues as they impact data completeness.

  16. 77 FR 71383 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... primary PM 2.5 , NO X and sulfur dioxide (SO 2 ) emissions inventories as satisfying the requirement in... Emission Standards for Vehicles and Gasoline Sulfur Standards. These emission control requirements result... also reduced the sulfur content of gasoline to 30 parts per million (ppm) beginning in January 2006...

  17. Physical Activity Stories: Assessing the "Meaning Standard" in Physical Education

    ERIC Educational Resources Information Center

    Johnson, Tyler G.

    2016-01-01

    The presence of the "meaning standard" in both national and state content standards suggests that professionals consider it an important outcome of a quality physical education program. However, only 10 percent of states require an assessment to examine whether students achieve this standard. The purpose of this article is to introduce…

  18. Quality in the molecular microbiology laboratory.

    PubMed

    Wallace, Paul S; MacKay, William G

    2013-01-01

    In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

  19. 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.

  20. Flow cytometry quality requirements for monitoring of minimal disease in plasma cell myeloma.

    PubMed

    Oldaker, Teri A; Wallace, Paul K; Barnett, David

    2016-01-01

    Current therapeutic approaches for plasma cell myeloma (PCM) attain an overall survival of more than 6 years for the majority of newly diagnosed patients. However, PFS and OS are the only accepted FDA clinical endpoints for demonstrating drug efficacy before they can be become frontline therapeutic options. There is, however, recognition that the increasing gap between drug development and approval for mainstream therapeutic use needs to be shortened. As such regulatory bodies such as the FDA are now considering whether biomarker response evaluation, as in measurement of minimal residual disease (MRD) as assessed by flow cytometry (FC), can provide an early, robust prediction of survival and therefore improve the drug approval process. Recently, FC MRD using a standardized eight-color antibody methodology has been shown to have a minimum sensitivity of 0.01% and an upper sensitivity of 0.001%. To ensure that all laboratories using this approach achieve the same levels of sensitivity it is crucially important to have standardized quality management procedures in place. This manuscript accompanies those published in this special issue and describes the minimum that is required for validating and quality monitoring of this highly specific test to ensure any laboratory, irrespective of location, will achieve the expected quality standards required. © 2015 International Clinical Cytometry Society.

  1. 40 CFR Appendix A to Subpart C of... - References

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...—References (1) American National Standard Quality Systems for Environmental Data and Technology Programs—Requirements with guidance for use, ANSI/ASQC E4-2004. Available from American Society for Quality, P.O. Box...

  2. 40 CFR Appendix A to Subpart C of... - References

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...—References (1) American National Standard Quality Systems for Environmental Data and Technology Programs—Requirements with guidance for use, ANSI/ASQC E4-2004. Available from American Society for Quality, P.O. Box...

  3. Region 7 States Air Quality Monitoring Plans - Iowa

    EPA Pesticide Factsheets

    National Ambient Air Quality Standard (NAAQS) - Iowa, Kansas, Missouri, and Nebraska; Annual Monitoring Network Plans, Five-Year Monitoring Network Assessments, and approval documentation. Each year, states are required to submit an annual monitoring netwo

  4. Region 7 States Air Quality Monitoring Plans - Missouri

    EPA Pesticide Factsheets

    National Ambient Air Quality Standard (NAAQS) - Iowa, Kansas, Missouri, and Nebraska; Annual Monitoring Network Plans, Five-Year Monitoring Network Assessments, and approval documentation. Each year, states are required to submit an annual monitoring netwo

  5. Region 7 States Air Quality Monitoring Plans - Nebraska

    EPA Pesticide Factsheets

    National Ambient Air Quality Standard (NAAQS) - Iowa, Kansas, Missouri, and Nebraska; Annual Monitoring Network Plans, Five-Year Monitoring Network Assessments, and approval documentation. Each year, states are required to submit an annual monitoring netwo

  6. Region 7 States Air Quality Monitoring Plans - Kansas

    EPA Pesticide Factsheets

    National Ambient Air Quality Standard (NAAQS) - Iowa, Kansas, Missouri, and Nebraska; Annual Monitoring Network Plans, Five-Year Monitoring Network Assessments, and approval documentation. Each year, states are required to submit an annual monitoring netwo

  7. 40 CFR Appendix A to Subpart A of... - References

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-1994. Available from American Society for Quality, P.O. Box 3005, Milwaukee, WI 53202 (http://qualitypress.asq.org). (2) American National Standard Quality Systems for Environmental Data and Technology Programs—Requirements with guidance for use, ANSI/ASQC E4-2004. Available from American Society for Quality...

  8. 30 CFR 75.1100 - Requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Requirements. 75.1100 Section 75.1100 Mineral... SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1100 Requirements. [Statutory Provision... conditions of the mine. The Secretary shall establish minimum requirements of the type, quality, and quantity...

  9. 30 CFR 75.1100 - Requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Requirements. 75.1100 Section 75.1100 Mineral... SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1100 Requirements. [Statutory Provision... conditions of the mine. The Secretary shall establish minimum requirements of the type, quality, and quantity...

  10. 30 CFR 75.1100 - Requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Requirements. 75.1100 Section 75.1100 Mineral... SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1100 Requirements. [Statutory Provision... conditions of the mine. The Secretary shall establish minimum requirements of the type, quality, and quantity...

  11. 30 CFR 75.1100 - Requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Requirements. 75.1100 Section 75.1100 Mineral... SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1100 Requirements. [Statutory Provision... conditions of the mine. The Secretary shall establish minimum requirements of the type, quality, and quantity...

  12. Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

    PubMed

    Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

    2009-12-01

    Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

  13. [Special aspects of quality of Tibetan medicines--insights from over 40 years of manufacturing experience in Switzerland].

    PubMed

    Schwabl, Alexandra; Gämperle, Erich

    2013-01-01

    Tibetan recipes are complex formulas from plant and mineral ingredients. Padma Inc. has been producing selected formulas from Tibetan Medicine in Switzerland since more than 40 years. Modern quality standards and Good Manufacturing Practice (GMP) guidelines are followed, ensuring the quality of the raw materials through the manufacturing processes to the finished product. The aim is to provide these valuable formulas to people in the West in a consistently high quality 'made in Switzerland'. The production according to modern quality standards is challenging, draws on many resources, and requires specialized expertise, e.g. in the procurement of raw materials and the quality analysis including pharmacognostic and botanical knowledge.

  14. Colposcopy audit for improving quality of service in areas with a high incidence of cervical cancer.

    PubMed

    Manopunya, Manatsawee; Suprasert, Prapaporn; Srisomboon, Jatupol; Kietpeerakool, Chumnan

    2010-01-01

    To audit routine colposcopy performance using 8 standard requirements of the National Health Service Cervical Screening Programme (NHSCSP). Records of women who underwent colposcopy for abnormal cervical cytology between January and December 2008 at Chiang Mai University Hospital, Thailand, were reviewed. The standard requirements were not achieved in 2 practices: (1) the proportion of women who had recordings of visibility of the transformation zone (96.6%) did not achieve the NHSCSP requirement of 100%; and (2) the rate of excisional biopsy (87.8%) was lower than the 95% minimum required. Colposcopic performance at Chiang Mai University Hospital was generally favorable. However, re-audit is necessary to ensure that unmet standards of performance are improved and achieved standards are maintained.

  15. Overview of the new National Near-Road Air Quality Monitoring Network

    EPA Science Inventory

    In 2010, EPA promulgated new National Ambient Air Quality Standards (NAAQS) for nitrogen dioxide (NO2). As part of this new NAAQS, EPA required the establishment of a national near-road air quality monitoring network. This network will consist of one NO2 near-road monitoring st...

  16. 77 FR 51686 - Specialty Crops; Import Regulations; New Pistachio Import Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... standards, thus promoting high quality product in the market place and fostering consumer satisfaction... designed to ensure that only high quality pistachios containing low levels of aflatoxin are shipped, thus promoting high quality product in the market place and fostering consumer satisfaction. The order, which was...

  17. 42 CFR 438.240 - Quality assessment and performance improvement program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Quality assessment and performance improvement... Performance Improvement Measurement and Improvement Standards § 438.240 Quality assessment and performance improvement program. (a) General rules. (1) The State must require, through its contracts, that each MCO and...

  18. Image quality metrics for volumetric laser displays

    NASA Astrophysics Data System (ADS)

    Williams, Rodney D.; Donohoo, Daniel

    1991-08-01

    This paper addresses the extensions to the image quality metrics and related human factors research that are needed to establish the baseline standards for emerging volume display technologies. The existing and recently developed technologies for multiplanar volume displays are reviewed with an emphasis on basic human visual issues. Human factors image quality metrics and guidelines are needed to firmly establish this technology in the marketplace. The human visual requirements and the display design tradeoffs for these prototype laser-based volume displays are addressed and several critical image quality issues identified for further research. The American National Standard for Human Factors Engineering of Visual Display Terminal Workstations (ANSIHFS-100) and other international standards (ISO, DIN) can serve as a starting point, but this research base must be extended to provide new image quality metrics for this new technology for volume displays.

  19. 76 FR 33647 - Approval and Promulgation of Determination of Attainment for the 1997 8-Hour Ozone Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-09

    ... Promulgation of Determination of Attainment for the 1997 8-Hour Ozone Standard: States of Missouri and Illinois... area has attained the 1997 8-hour National Ambient Air Quality Standard (NAAQS) for ozone. The St... with other requirements related to the attainment of the 1997 8-hour ozone standard are suspended...

  20. 42 CFR 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Test systems, equipment, instruments... REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1252 Standard: Test systems, equipment...) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in...

  1. 7 CFR 205.640 - Fees and other charges for accreditation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED... Marketing Service, through its Quality Systems Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization “General Requirements for Bodies...

  2. CSER-98-002: Criticality analysis for the storage of special nuclear material sources and standards in the WRAP facility

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

    GOLDBERG, H.J.

    1999-05-18

    The Waste Receiving and Processing (WRAP) Facility will store uranium and transuranic (TRU) sources and standards for certification that WRAP meets the requirements of the Quality Assurance Program Plan (QAPP) for the Waste Isolation Pilot Plant (WIPP). In addition, WRAP must meet internal requirements for testing and validation of measuring instruments for nondestructive assay (NDA). In order to be certified for WIPP, WRAP will participate in the NDA Performance Demonstration Program (PDP). This program is a blind test of the NDA capabilities for TRU waste. It is intended to ensure that the NDA capabilities of this facility satisfy the requirementsmore » of the quality assurance program plan for the WIPP. The PDP standards have been provided by the Los Alamos National Laboratory (LANL) for this program. These standards will be used in the WRAP facility.« less

  3. Using Clinical Data Standards to Measure Quality: A New Approach.

    PubMed

    D'Amore, John D; Li, Chun; McCrary, Laura; Niloff, Jonathan M; Sittig, Dean F; McCoy, Allison B; Wright, Adam

    2018-04-01

     Value-based payment for care requires the consistent, objective calculation of care quality. Previous initiatives to calculate ambulatory quality measures have relied on billing data or individual electronic health records (EHRs) to calculate and report performance. New methods for quality measure calculation promoted by federal regulations allow qualified clinical data registries to report quality outcomes based on data aggregated across facilities and EHRs using interoperability standards.  This research evaluates the use of clinical document interchange standards as the basis for quality measurement.  Using data on 1,100 patients from 11 ambulatory care facilities and 5 different EHRs, challenges to quality measurement are identified and addressed for 17 certified quality measures.  Iterative solutions were identified for 14 measures that improved patient inclusion and measure calculation accuracy. Findings validate this approach to improving measure accuracy while maintaining measure certification.  Organizations that report care quality should be aware of how identified issues affect quality measure selection and calculation. Quality measure authors should consider increasing real-world validation and the consistency of measure logic in respect to issues identified in this research. Schattauer GmbH Stuttgart.

  4. Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market.

    PubMed

    Merger, Eduard; Pistorius, Till

    2011-08-17

    In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a strong track record of successful projects. Project developers require clear, easily and practically applicable standards at lowest possible costs with a high potential in order to achieve good carbon prices, while buyers require that standards are legitimate, credible and that no public criticism arises when carbon credits are purchased from projects certified by a certain standard. Despite the fragmented and immature state of the OTC market, standards act as 'market-making' intermediaries and contribute to the quality and transparency of the OTC market. However, the variety of different standards imposes new hurdles for their efficiency and often creates confusion instead of confidence among potential buyers. Despite the lacking legitimacy of the standards, pressures from the institutional environment on standards ensure a minimum quality of carbon credits (including positive social and environmental impacts of carbon credits) that serves as an insurance mechanism for the integrity of standards. Its unregulated nature and the pressure from an increasingly competitive environment provides innovative space to deliver efficient certification procedures without imposing unreasonably high transaction costs on market actors. Furthermore, voluntary standards imply a more innovative certification approach, as one legal authority could do, because standards have to compete for adopters backed by civil society organisations. Thereby, the forest sector in OTC voluntary market bears great opportunities to provide the forest sector with crucial lessons for international climate policy and governmental institutions when designing regulation for forest regulation such as international and national REDDplus schemes.

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

    Voytchev, M; Radev, R; Chiaro, P

    The International Electrotechnical Commission (IEC) is the leading and oldest global organization with over 100 years history of developing and publishing international standards for all electrical, electronic and related technologies, including radiation detection instrumentation. Subcommittee 45B 'Radiation Protection Instrumentation' of the IEC has recently started the development of two standards on radiation-generating devices. IEC 62463 'Radiation protection instrumentation--X-ray Systems for the Screening of Persons for Security and the Carrying of Illicit Items' is applicable to X-ray systems designed for screening people to detect if they are carrying objects such as weapons, explosives, chemical and biological agents and other concealed itemsmore » that could be used for criminal purposes, e.g. terrorist use, drug smuggling, etc. IEC 62523 'Radiation protection instrumentation--Cargo/Vehicle radiographic inspection systems' applies to cargo/vehicle imaging inspection systems using accelerator produced X-ray or gamma radiation to obtain images of the screened objects (e.g. cargo containers, transport and passenger vehicles and railroad cars). The objective of both standards is to specify standard requirements and general characteristics and test procedures, as well as, radiation, electrical, environmental, mechanical, and safety requirements and to provide examples of acceptable methods to test these requirements. In particular the standards address the design requirements as they relate to the radiation protection of the people being screened, people who are in the vicinity of the equipment and the operators. The standard IEC 62463 does not deal with the performance requirements for the quality of the object detection. Compliance with the standards requirements will provide the manufacturers with internationally acceptable specifications and the device users with assurance of the rigorous quality and accuracy of the measurements in relation to the radiological safety of the equipment. The main characteristics of IEC 62463 and IEC 62523 standards are presented and as well as the IEC methodology of standard development and approval.« less

  6. KSC Center Director Bridges accepts an ISO 9001 certificate from DNV

    NASA Technical Reports Server (NTRS)

    1998-01-01

    Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

  7. KSC-98pc907

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

  8. KSC-98pc908

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

  9. US EPA Nonattainment Areas and Designations

    EPA Pesticide Factsheets

    This web service contains the following state level layers:Ozone 8-hr (1997 standard), Ozone 8-hr (2008 standard), Lead (2008 standard), SO2 1-hr (2010 standard), PM2.5 24hr (2006 standard), PM2.5 Annual (1997 standard), PM2.5 Annual (2012 standard), and PM10 (1987 standard). Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NonattainmentAreas/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each

  10. Quality assurance grading guidelines for research and development at DOE facilities

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

    Powell, T.B.; Morris, R.N.

    1993-01-01

    The quality assurance (QA) requirements for the US Department of Energy (DOE) are established in DOE Order 5700.6C. This order is applicable for all DOE departmental elements, management, and maintenance and operating contractors and requires that documented Quality Assurance Programs (QAPs) are prepared at all levels; it has one attachment. The DOE Office of Energy Research (DOE-ER) has issued a standard to ensure implementation of the full intent of this order in the ER community.

  11. The new national ambient air quality standards in transportation planning

    DOT National Transportation Integrated Search

    2004-03-01

    The purpose of this project is to identify the strategies adopted by several states around the country for preparing to adjust their transportation planning practices to the regulatory requirements associated with designation as an air quality nonatt...

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

    PubMed

    Lovgalev, A S

    1998-01-01

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

  13. Setting and Reviewing Standards to Control Carbon Monoxide (CO) Pollution in Outdoor Air

    EPA Pesticide Factsheets

    EPA sets National Ambient Air Quality Standards (NAAQS) for CO to protect public health and to protect public welfare. The Clean Air Act also requires EPA to periodically review and revise them if appropriate.

  14. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  15. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  16. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  17. 40 CFR 49.154 - Permit application requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., production rates and operating schedules. (vii) Identification and description of any existing air pollution... pollution prevention techniques, air pollution control devices, design standards, equipment standards, work... ASSISTANCE INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT General Federal Implementation Plan Provisions...

  18. 40 CFR 49.154 - Permit application requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., production rates and operating schedules. (vii) Identification and description of any existing air pollution... pollution prevention techniques, air pollution control devices, design standards, equipment standards, work... ASSISTANCE INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT General Federal Implementation Plan Provisions...

  19. 40 CFR 49.154 - Permit application requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., production rates and operating schedules. (vii) Identification and description of any existing air pollution... pollution prevention techniques, air pollution control devices, design standards, equipment standards, work... ASSISTANCE INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT General Federal Implementation Plan Provisions...

  20. 40 CFR 49.154 - Permit application requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., production rates and operating schedules. (vii) Identification and description of any existing air pollution... pollution prevention techniques, air pollution control devices, design standards, equipment standards, work... ASSISTANCE INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT General Federal Implementation Plan Provisions...

  1. Updated standards and processes for accreditation of echocardiographic laboratories from The European Association of Cardiovascular Imaging.

    PubMed

    Popescu, Bogdan A; Stefanidis, Alexandros; Nihoyannopoulos, Petros; Fox, Kevin F; Ray, Simon; Cardim, Nuno; Rigo, Fausto; Badano, Luigi P; Fraser, Alan G; Pinto, Fausto; Zamorano, Jose Luis; Habib, Gilbert; Maurer, Gerald; Lancellotti, Patrizio; Andrade, Maria Joao; Donal, Erwan; Edvardsen, Thor; Varga, Albert

    2014-07-01

    Standards for echocardiographic laboratories were proposed by the European Association of Echocardiography (now the European Association of Cardiovascular Imaging) 7 years ago in order to raise standards of practice and improve the quality of care. Criteria and requirements were published at that time for transthoracic, transoesophageal, and stress echocardiography. This paper reassesses and updates the quality standards to take account of experience and the technical developments of modern echocardiographic practice. It also discusses quality control, the incentives for laboratories to apply for accreditation, the reaccreditation criteria, and the current status and future prospects of the laboratory accreditation process. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  2. Standard requirements for GCP-compliant data management in multinational clinical trials.

    PubMed

    Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve; Lauritsen, Jens; Salas, Nader; Schade-Brittinger, Carmen; Wittenberg, Michael; McPherson, Gladys; McCourt, John; Gueyffier, Francois; Lorimer, Andrea; Torres, Ferràn

    2011-03-22

    A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.

  3. Ambient Air Quality Data Inventory

    EPA Pesticide Factsheets

    The Office of Air and Radiation's (OAR) Ambient Air Quality Data (Current) contains ambient air pollution data collected by EPA, other federal agencies, as well as state, local, and tribal air pollution control agencies. Its component data sets have been collected over the years from approximately 10,000 monitoring sites, of which approximately 5,000 are currently active. OAR's Office of Air Quality Planning and Standards (OAQPS) and other internal and external users, rely on this data to assess air quality, assist in Attainment/Non-Attainment designations, evaluate State Implementation Plans for Non-Attainment Areas, perform modeling for permit review analysis, and other air quality management functions. Air quality information is also used to prepare reports for Congress as mandated by the Clean Air Act. This data covers air quality data collected after 1980, when the Clean Air Act requirements for monitoring were significantly modified. Air quality data from the Agency's early years (1970s) remains available (see OAR PRIMARY DATA ASSET: Ambient Air Quality Data -- Historical), but because of technical and definitional differences the two data assets are not directly comparable. The Clean Air Act of 1970 provided initial authority for monitoring air quality for Conventional Air Pollutants (CAPs) for which EPA has promulgated National Ambient Air Quality Standards (NAAQS). Requirements for monitoring visibility-related parameters were added in 1977. Requiremen

  4. NAAQS IMPLEMENTATION

    EPA Science Inventory

    The Clean Air Act requires EPA to set National Ambient Air Quality Standards (NAAQS) for six criteria pollutants (lead, carbon monoxide, sulfur dioxide, nitrous oxides, ozone, and particulate matter). After setting NAAQS, there are several activities required to implement the st...

  5. Implementing a Quality Management System in the Medical Microbiology Laboratory.

    PubMed

    Carey, Roberta B; Bhattacharyya, Sanjib; Kehl, Sue C; Matukas, Larissa M; Pentella, Michael A; Salfinger, Max; Schuetz, Audrey N

    2018-07-01

    This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum. Copyright © 2018 American Society for Microbiology.

  6. 40 CFR 130.10 - State submittals to EPA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... QUALITY PLANNING AND MANAGEMENT § 130.10 State submittals to EPA. (a) The following must be submitted... the annual section 205(j) certification or update of the 305(b) water quality report; (Approved by OMB... water quality standards (WQS) (303(c)). (Approved by OMB under 2040-0049) (b) The Act also requires that...

  7. 40 CFR 130.10 - State submittals to EPA.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... QUALITY PLANNING AND MANAGEMENT § 130.10 State submittals to EPA. (a) The following must be submitted... the annual section 205(j) certification or update of the 305(b) water quality report; (Approved by OMB... water quality standards (WQS) (303(c)). (Approved by OMB under 2040-0049) (b) The Act also requires that...

  8. 40 CFR 130.10 - State submittals to EPA.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... QUALITY PLANNING AND MANAGEMENT § 130.10 State submittals to EPA. (a) The following must be submitted... the annual section 205(j) certification or update of the 305(b) water quality report; (Approved by OMB... water quality standards (WQS) (303(c)). (Approved by OMB under 2040-0049) (b) The Act also requires that...

  9. 40 CFR 130.10 - State submittals to EPA.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... QUALITY PLANNING AND MANAGEMENT § 130.10 State submittals to EPA. (a) The following must be submitted... the annual section 205(j) certification or update of the 305(b) water quality report; (Approved by OMB... water quality standards (WQS) (303(c)). (Approved by OMB under 2040-0049) (b) The Act also requires that...

  10. 40 CFR 130.10 - State submittals to EPA.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... QUALITY PLANNING AND MANAGEMENT § 130.10 State submittals to EPA. (a) The following must be submitted... the annual section 205(j) certification or update of the 305(b) water quality report; (Approved by OMB... water quality standards (WQS) (303(c)). (Approved by OMB under 2040-0049) (b) The Act also requires that...

  11. [Essential guidelines for Quality Management System].

    PubMed

    Daunizeau, A

    2013-06-01

    The guidelines describe the essential parts of the quality management system to fulfil the requirements of the standard EN ISO 15 189. It includes mainly the organisation, the definition of responsibilities, training of personnel, the document control, the quality control, identification and control of nonconformities, corrective actions, preventive actions and evaluation, as audits and the management review.

  12. Determining RNA quality for NextGen sequencing: some exceptions to the gold standard rule of 23S to 16S rRNA ratio

    USDA-ARS?s Scientific Manuscript database

    Using next-generation-sequencing technology to assess entire transcriptomes requires high quality starting RNA. Currently, RNA quality is routinely judged using automated microfluidic gel electrophoresis platforms and associated algorithms. Here we report that such automated methods generate false-n...

  13. Using TQM and ISO 9000 Principles in Assuring Education Service Quality.

    ERIC Educational Resources Information Center

    Kabashkin, Igor; Michnev, Boris; Utchin, Georgy

    1998-01-01

    Describes Riga Aviation University's movement from a controlled professional-education program to a system of contract relations with students as education service customers. Discusses a study of students' demands, requirements, and issues and the development of a quality assurance system based on Total Quality Management and ISO 9000 standards.…

  14. [Recommendations for implementing the quality policy and organisation of a quality management system].

    PubMed

    Daunizeau, A

    2013-06-01

    Preliminary issues to implement a quality management system are described. They include the definition of the structure, a hierarchical and functional organization chart and the engagement of the whole personnel to apply the requirements of the standard EN ISO 15189. The policy has to be translated into objectives.

  15. 42 CFR 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test systems, equipment, instruments, reagents, materials, and supplies. 493.1252 Section 493.1252 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived...

  16. A Double Standard and Dubious Ethics in Determining Quality Teaching

    ERIC Educational Resources Information Center

    Reardon, R. Martin

    2016-01-01

    "Double Standard" was created by the actors who appeared in the accompanying video in spring 2014, as part fulfillment of the requirements for a master's-level class highlighting ethics in education for future educational administrators. A double standard comes into focus as an incoming middle school principal establishes procedures she…

  17. 75 FR 3509 - Public Company Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-21

    ... Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No. 7, Engagement Quality... Accounting Oversight Board (the ``Board'' or the ``PCAOB'') filed with the Securities and Exchange Commission... standards for public company audits, including a requirement for each registered public accounting firm to...

  18. 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.

  19. Design of a medical and laboratory equipment management program for the new standards certification achievement in Mexico.

    PubMed

    Franco-Clark, D; Pimentel-Aguilar, A B; Rodriguez-Vera, R

    2010-01-01

    Certification for healthcare institutions in Mexico is ruled by 2009 standards homologated with the Joint Commission International criteria. Nowadays, healthcare requires of medical equipment and devices, so it has become necessary to implement guidelines for its adequate management in order to reach the highest level of quality and safety at the lowest cost. The objective of this work was to develop a Medical and Laboratory Equipment Management Program, oriented to the improvement of quality, effectiveness and efficiency of the technological resources in order to meet the certification requirements. The result of this work allows to have an auto evaluation tool that focuses the efforts of the National Institute for Respiratory Diseases to the achievement of the new requirements established for the certification.

  20. Emerging developments in the standardized chemical characterization of indoor air quality.

    PubMed

    Nehr, Sascha; Hösen, Elisabeth; Tanabe, Shin-Ichi

    2017-01-01

    Despite the fact that the special characteristics of indoor air pollution make closed environments quite different from outdoor environments, the conceptual ideas for assessing air quality indoors and outdoors are similar. Therefore, the elaboration of International Standards for air quality characterization in view of controlling indoor air quality should resort to this common basis. In this short review we describe the possibilities of standardization of tools dedicated to indoor air quality characterization with a focus on the tools permitting to study the indoor air chemistry. The link between indoor exposure and health as well as the critical processes driving the indoor air quality are introduced. Available International Standards for the assessment of indoor air quality are depicted. The standards comprise requirements for the sampling on site, the analytical procedures, and the determination of material emissions. To date, these standardized procedures assure that indoor air, settled dust and material samples are analyzed in a comparable manner. However, existing International Standards exclusively specify conventional, event-driven target-screening using discontinuous measurement methods for long-lived pollutants. Therefore, this review draws a parallel between physico-chemical processes in indoor and outdoor environments. The achievements in atmospheric sciences also improve our understanding of indoor environments. The community of atmospheric scientists can be both ideal and supporter for researchers in the area of indoor air quality characterization. This short review concludes with propositions for future standardization activities for the chemical characterization of indoor air quality. Future standardization efforts should focus on: (i) the elaboration of standardized measurement methods and measurement strategies for online monitoring of long-lived and short-lived pollutants, (ii) the assessment of the potential and the limitations of non-target screening, (iii) the paradigm shift from event-driven investigations to systematic approaches to characterize indoor environments, and (iv) the development of tools for policy implementation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. 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.

  2. Value-Based Requirements Traceability: Lessons Learned

    NASA Astrophysics Data System (ADS)

    Egyed, Alexander; Grünbacher, Paul; Heindl, Matthias; Biffl, Stefan

    Traceability from requirements to code is mandated by numerous software development standards. These standards, however, are not explicit about the appropriate level of quality of trace links. From a technical perspective, trace quality should meet the needs of the intended trace utilizations. Unfortunately, long-term trace utilizations are typically unknown at the time of trace acquisition which represents a dilemma for many companies. This chapter suggests ways to balance the cost and benefits of requirements traceability. We present data from three case studies demonstrating that trace acquisition requires broad coverage but can tolerate imprecision. With this trade-off our lessons learned suggest a traceability strategy that (1) provides trace links more quickly, (2) refines trace links according to user-defined value considerations, and (3) supports the later refinement of trace links in case the initial value consideration has changed over time. The scope of our work considers the entire life cycle of traceability instead of just the creation of trace links.

  3. Design Of Measurements For Evaluating Readiness Of Technoware Components To Meet The Required Standard Of Products

    NASA Astrophysics Data System (ADS)

    Fauzi, Ilham; Muharram Hasby, Fariz; Irianto, Dradjad

    2018-03-01

    Although government is able to make mandatory standards that must be obeyed by the industry, the respective industries themselves often have difficulties to fulfil the requirements described in those standards. This is especially true in many small and medium sized enterprises that lack the required capital to invest in standard-compliant equipment and machineries. This study aims to develop a set of measurement tools for evaluating the level of readiness of production technology with respect to the requirements of a product standard based on the quality function deployment (QFD) method. By combining the QFD methodology, UNESCAP Technometric model [9] and Analytic Hierarchy Process (AHP), this model is used to measure a firm’s capability to fulfill government standard in the toy making industry. Expert opinions from both the governmental officers responsible for setting and implementing standards and the industry practitioners responsible for managing manufacturing processes are collected and processed to find out the technological capabilities that should be improved by the firm to fulfill the existing standard. This study showed that the proposed model can be used successfully to measure the gap between the requirements of the standard and the readiness of technoware technological component in a particular firm.

  4. Identifying the Gaps in Practice for Combating Lead in Drinking Water in Hong Kong

    PubMed Central

    Lee, Wai Ling; Jia, Jie; Bao, Yani

    2016-01-01

    Excessive lead has been found in drinking water in Hong Kong in tests carried out in 2015. Investigations have identified that the problem in public rental housing estates was caused by the problematic solders used in the plumbing, and recommendations on enhancing the quality control system and strengthening the relevant water quality standards have been proposed. The cause for the same problem happening in other premises where soldering has not been adopted for water pipe connections is left unidentified. Considering the unidentified cause and the recommendations made, this study aims to identify the gaps in practice followed in Hong Kong for safeguarding the water quality of new installations. A holistic review of governing ordinances and regulations, products and materials used and the testing and commissioning requirements adopted in Hong Kong and elsewhere in the world were conducted. Based on international practices and parametric analysis, it was found that there are gaps in practices followed in Hong Kong, which are directly and indirectly leading to the lead-in-water crisis. Recommendations for improvement in the quality control system, and the water quality standards including the allowable lead content and leaching limit for products and materials and the testing and commissioning requirements on plumbing installations have been made. The review and the identified gaps would become useful reference for countries in strengthening their relevant water quality standards. PMID:27706062

  5. Identifying the Gaps in Practice for Combating Lead in Drinking Water in Hong Kong.

    PubMed

    Lee, Wai Ling; Jia, Jie; Bao, Yani

    2016-09-30

    Excessive lead has been found in drinking water in Hong Kong in tests carried out in 2015. Investigations have identified that the problem in public rental housing estates was caused by the problematic solders used in the plumbing, and recommendations on enhancing the quality control system and strengthening the relevant water quality standards have been proposed. The cause for the same problem happening in other premises where soldering has not been adopted for water pipe connections is left unidentified. Considering the unidentified cause and the recommendations made, this study aims to identify the gaps in practice followed in Hong Kong for safeguarding the water quality of new installations. A holistic review of governing ordinances and regulations, products and materials used and the testing and commissioning requirements adopted in Hong Kong and elsewhere in the world were conducted. Based on international practices and parametric analysis, it was found that there are gaps in practices followed in Hong Kong, which are directly and indirectly leading to the lead-in-water crisis. Recommendations for improvement in the quality control system, and the water quality standards including the allowable lead content and leaching limit for products and materials and the testing and commissioning requirements on plumbing installations have been made. The review and the identified gaps would become useful reference for countries in strengthening their relevant water quality standards.

  6. Ozone NAAQS Review: Policy Assessment

    EPA Science Inventory

    Ozone is one of the six major air pollutants for which EPA has issued air quality criteria and established national ambient air quality standards (NAAQS) based on those criteria. The Clean Air Act (CAA) requires EPA to periodically review and revise, as appropriate, existing air...

  7. Towards tributyltin quantification in natural water at the Environmental Quality Standard level required by the Water Framework Directive.

    PubMed

    Alasonati, Enrica; Fettig, Ina; Richter, Janine; Philipp, Rosemarie; Milačič, Radmila; Sčančar, Janez; Zuliani, Tea; Tunç, Murat; Bilsel, Mine; Gören, Ahmet Ceyhan; Fisicaro, Paola

    2016-11-01

    The European Union (EU) has included tributyltin (TBT) and its compounds in the list of priority water pollutants. Quality standards demanded by the EU Water Framework Directive (WFD) require determination of TBT at so low concentration level that chemical analysis is still difficult and further research is needed to improve the sensitivity, the accuracy and the precision of existing methodologies. Within the frame of a joint research project "Traceable measurements for monitoring critical pollutants under the European Water Framework Directive" in the European Metrology Research Programme (EMRP), four metrological and designated institutes have developed a primary method to quantify TBT in natural water using liquid-liquid extraction (LLE) and species-specific isotope dilution mass spectrometry (SSIDMS). The procedure has been validated at the Environmental Quality Standard (EQS) level (0.2ngL(-1) as cation) and at the WFD-required limit of quantification (LOQ) (0.06ngL(-1) as cation). The LOQ of the methodology was 0.06ngL(-1) and the average measurement uncertainty at the LOQ was 36%, which agreed with WFD requirements. The analytical difficulties of the method, namely the presence of TBT in blanks and the sources of measurement uncertainties, as well as the interlaboratory comparison results are discussed in detail. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

    PubMed Central

    Ho, Bella; Ho, Eric

    2012-01-01

    Introduction: ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Materials and methods: Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. Results: For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). Conclusion: Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories. PMID:22838190

  9. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria.

    PubMed

    Ho, Bella; Ho, Eric

    2012-01-01

    ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods - from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that 15015189 contributed to quality improvement of accredited laboratories.

  10. [Quality Management in Medicine: What the Surgeon Needs to Know].

    PubMed

    Holtel, M; Roßmüller, T; Frommhold, K

    2016-10-01

    Quality management (QM) is a method used in the field of economics that was adopted late by the medical sector. The coincidence of quality management and what is referred to as economisation in medicine frequently leads to QM being - incorrectly - perceived as part of the economisation problem rather than as part of its solution. Quality assurance defines and observes key performance indicators for the achievement of quality objectives. QM is a form of active management that intends to systematically exclude the effects of chance. It is supposed to enable those in charge of an institution to deal with complex processes, to influence them and achieve quality even under unfavourable circumstances. Clearly defined written standards are an important aspect of QM and allow for 80 % of patients to be treated faster and less labour-intensively and thus to create more capacity for the individual treatment of the 20 % of patients requiring other than routine care. Standards provide a framework to rely on for department heads and other staff alike. They reduce complexity, support processes in stress situations and prevent inconsistent decisions in the course of treatment. Document management ensures transparent and up-to-date in-house standards and creates continuity. Good documents are short, easy to use, and, at the same time, comply with requirements. Specifications describe in-house standards; validation documents provide a forensically sound documentation. Quality management has a broad impact on an institution. It helps staff reflect on their daily work, and it initiates a reporting and auditing system as well as the systematic management of responses to surveys and complaints. Risk management is another aspect of QM; it provides structures to identify, analyse, assess and modify risks and subject them to risk controlling. Quality management is not necessarily associated with certification. However, if certification is intended, it serves to define requirements, increase motivation for the implementation of measures to be taken, and provide long-term continuity in newly adopted processes. Specialist certificates issued by medical associations frequently emphasise an interdisciplinary treatment approach; however, their certification processes are often of poor quality. The effectiveness and efficiency is evident for individual QM instruments in medicine. It is very likely that quality management improves effectiveness in the whole field of medicine, but this has yet to be proved. Georg Thieme Verlag KG Stuttgart · New York.

  11. Accreditation the Education Development Centers of Medical-Sciences Universities: Another Step toward Quality Improvement in Education

    PubMed Central

    Haghdoost, AA; Momtazmanesh, N; Shoghi, F; Mohagheghi, M; Mehrolhassani, MH

    2013-01-01

    Background: In order to improve the quality of education in universities of medical sciences (UMS), and because of the key role of education development centers (EDCs), an accreditation scheme was developed to evaluate their performance. Method: A group of experts in the medical education field was selected based on pre-defined criteria by EDC of Ministry of Health and Medical education. The team, worked intensively for 6 months to develop a list of essential standards to assess the performance of EDCs. Having checked for the content validity of standards, clear and measurable indicators were created via consensus. Then, required information were collected from UMS EDCs; the first round of accreditation was carried out just to check the acceptability of this scheme, and make force universities to prepare themselves for the next factual round of accreditation. Results: Five standards domains were developed as the conceptual framework for defining main categories of indicators. This included: governing and leadership, educational planning, faculty development, assessment and examination and research in education. Nearly all of UMS filled all required data forms precisely with minimum confusion which shows the practicality of this accreditation scheme. Conclusion: It seems that the UMS have enough interest to provide required information for this accreditation scheme. However, in order to receive promising results, most of universities have to work intensively in order to prepare minimum levels in all required standards. However, it seems that in long term, implementation of a valid accreditation scheme plays an important role in improvement of the quality of medical education around the country. PMID:23865031

  12. Accreditation the Education Development Centers of Medical-Sciences Universities: Another Step toward Quality Improvement in Education.

    PubMed

    Haghdoost, Aa; Momtazmanesh, N; Shoghi, F; Mohagheghi, M; Mehrolhassani, Mh

    2013-01-01

    In order to improve the quality of education in universities of medical sciences (UMS), and because of the key role of education development centers (EDCs), an accreditation scheme was developed to evaluate their performance. A group of experts in the medical education field was selected based on pre-defined criteria by EDC of Ministry of Health and Medical education. The team, worked intensively for 6 months to develop a list of essential standards to assess the performance of EDCs. Having checked for the content validity of standards, clear and measurable indicators were created via consensus. Then, required information were collected from UMS EDCs; the first round of accreditation was carried out just to check the acceptability of this scheme, and make force universities to prepare themselves for the next factual round of accreditation. Five standards domains were developed as the conceptual framework for defining main categories of indicators. This included: governing and leadership, educational planning, faculty development, assessment and examination and research in education. Nearly all of UMS filled all required data forms precisely with minimum confusion which shows the practicality of this accreditation scheme. It seems that the UMS have enough interest to provide required information for this accreditation scheme. However, in order to receive promising results, most of universities have to work intensively in order to prepare minimum levels in all required standards. However, it seems that in long term, implementation of a valid accreditation scheme plays an important role in improvement of the quality of medical education around the country.

  13. Improving the Quality of Academic Services through Implementation of Internal Quality Assurance System in State Institute of Islamic Studies STS Jambi

    ERIC Educational Resources Information Center

    Iskandar

    2017-01-01

    Implementation of quality assurance systems in IAIN STS Jambi implemented in early 2012, through the build system of internal quality assurance based on ISO 9001: 2008, in the process of implementation required strong reasons behind not growing atmosphere of academic standards of accreditation of study programs and institutions that are reflected…

  14. Providing Data Quality Information for Remote Sensing Applications

    NASA Astrophysics Data System (ADS)

    Albrecht, F.; Blaschke, T.; Lang, S.; Abdulmutalib, H. M.; Szabó, G.; Barsi, Á.; Batini, C.; Bartsch, A.; Kugler, Zs.; Tiede, D.; Huang, G.

    2018-04-01

    The availability and accessibility of remote sensing (RS) data, cloud processing platforms and provided information products and services has increased the size and diversity of the RS user community. This development also generates a need for validation approaches to assess data quality. Validation approaches employ quality criteria in their assessment. Data Quality (DQ) dimensions as the basis for quality criteria have been deeply investigated in the database area and in the remote sensing domain. Several standards exist within the RS domain but a general classification - established for databases - has been adapted only recently. For an easier identification of research opportunities, a better understanding is required how quality criteria are employed in the RS lifecycle. Therefore, this research investigates how quality criteria support decisions that guide the RS lifecycle and how they relate to the measured DQ dimensions. Subsequently follows an overview of the relevant standards in the RS domain that is matched to the RS lifecycle. Conclusively, the required research needs are identified that would enable a complete understanding of the interrelationships between the RS lifecycle, the data sources and the DQ dimensions, an understanding that would be very valuable for designing validation approaches in RS.

  15. Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market

    PubMed Central

    2011-01-01

    Background In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. Results All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a strong track record of successful projects. Project developers require clear, easily and practically applicable standards at lowest possible costs with a high potential in order to achieve good carbon prices, while buyers require that standards are legitimate, credible and that no public criticism arises when carbon credits are purchased from projects certified by a certain standard. Conclusions Despite the fragmented and immature state of the OTC market, standards act as 'market-making' intermediaries and contribute to the quality and transparency of the OTC market. However, the variety of different standards imposes new hurdles for their efficiency and often creates confusion instead of confidence among potential buyers. Despite the lacking legitimacy of the standards, pressures from the institutional environment on standards ensure a minimum quality of carbon credits (including positive social and environmental impacts of carbon credits) that serves as an insurance mechanism for the integrity of standards. Its unregulated nature and the pressure from an increasingly competitive environment provides innovative space to deliver efficient certification procedures without imposing unreasonably high transaction costs on market actors. Furthermore, voluntary standards imply a more innovative certification approach, as one legal authority could do, because standards have to compete for adopters backed by civil society organisations. Thereby, the forest sector in OTC voluntary market bears great opportunities to provide the forest sector with crucial lessons for international climate policy and governmental institutions when designing regulation for forest regulation such as international and national REDDplus schemes. PMID:21849036

  16. The production and quality of tomato concentrates.

    PubMed

    Hayes, W A; Smith, P G; Morris, A E

    1998-10-01

    The standards and specifications for the quality and composition of tomato concentrates are reviewed. The main quality parameters of tomato puree and paste are color, consistency and flavor. Overall, there is an absence of standardization of methods and instruments to define quality. While color can now be measured objectively, there are currently no standard color requirements for tomato concentrates. Rheological measurements on both tomato juice and concentrates are reviewed; the power law finds wide applicability, although other rheological characteristics, particularly time dependency, have received far less attention and there has been little effort to relate rheological understanding to the commonly used empirical tests such as consistency measurements. The volatiles responsible for flavor and odor have been identified to the point where the natural odor of tomato paste can be imitated. Attempts to develop objective methods as a substitute for sensory assessment are reviewed.

  17. Implementing a Data Quality Strategy to Simplify Access to Data

    NASA Astrophysics Data System (ADS)

    Druken, K. A.; Trenham, C. E.; Evans, B. J. K.; Richards, C. J.; Wang, J.; Wyborn, L. A.

    2016-12-01

    To ensure seamless programmatic access for data analysis (including machine learning), standardization of both data and services is vital. At the Australian National Computational Infrastructure (NCI) we have developed a Data Quality Strategy (DQS) that currently provides processes for: (1) the consistency of data structures in the underlying High Performance Data (HPD) platform; (2) quality control through compliance with recognized community standards; and (3) data quality assurance through demonstrated functionality across common platforms, tools and services. NCI hosts one of Australia's largest repositories (10+ PBytes) of research data collections spanning datasets from climate, coasts, oceans and geophysics through to astronomy, bioinformatics and the social sciences. A key challenge is the application of community-agreed data standards to the broad set of Earth systems and environmental data that are being used. Within these disciplines, data span a wide range of gridded, ungridded (i.e., line surveys, point clouds), and raster image types, as well as diverse coordinate reference projections and resolutions. By implementing our DQS we have seen progressive improvement in the quality of the datasets across the different subject domains, and through this, the ease by which the users can programmatically access the data, either in situ or via web services. As part of its quality control procedures, NCI has developed a compliance checker based upon existing domain standards. The DQS also includes extensive Functionality Testing which include readability by commonly used libraries (e.g., netCDF, HDF, GDAL, etc.); accessibility by data servers (e.g., THREDDS, Hyrax, GeoServer), validation against scientific analysis and programming platforms (e.g., Python, Matlab, QGIS); and visualization tools (e.g., ParaView, NASA Web World Wind). These tests ensure smooth interoperability between products and services as well as exposing unforeseen requirements and dependencies. The results provide an important component of quality control within the DQS as well as clarifying the requirement for any extensions to the relevant standards that help support the uptake of data by broader international communities.

  18. Chiropractic quality assurance: standards and guidelines

    PubMed Central

    Gatterman, Meridel I; Dobson, Thomas P; LeFevbre, Ron

    2001-01-01

    Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.

  19. The Usefulness of Quality Assurance for University Management and Academic Staff: A Case Study of Finland and Iceland

    ERIC Educational Resources Information Center

    Haapakorpi, Arja; Geirsdóttir, Guðrún; Jóhannsdóttir, Gyða

    2013-01-01

    With quality assurance related to the Bologna goals, universities are required to fulfil internationally accepted standardized criteria of quality. This tends to reinforce control in assessment. However, control-oriented evaluations seem to lack meaning for academic staff. The article explored the possibilities and space for improvement-oriented…

  20. 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...

  1. 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...

  2. Measuring health care process quality with software quality measures.

    PubMed

    Yildiz, Ozkan; Demirörs, Onur

    2012-01-01

    Existing quality models focus on some specific diseases, clinics or clinical areas. Although they contain structure, process, or output type measures, there is no model which measures quality of health care processes comprehensively. In addition, due to the not measured overall process quality, hospitals cannot compare quality of processes internally and externally. To bring a solution to above problems, a new model is developed from software quality measures. We have adopted the ISO/IEC 9126 software quality standard for health care processes. Then, JCIAS (Joint Commission International Accreditation Standards for Hospitals) measurable elements were added to model scope for unifying functional requirements. Assessment (diagnosing) process measurement results are provided in this paper. After the application, it was concluded that the model determines weak and strong aspects of the processes, gives a more detailed picture for the process quality, and provides quantifiable information to hospitals to compare their processes with multiple organizations.

  3. [Status and suggestions for adjuvant standard for Chinese materia medica processing in China].

    PubMed

    Yang, Chun-Yu; Cao, Hui; Wang, Xiao-Tao; Tu, Jia-Sheng; Qian, Zhong-Zhi; Yu, Zhi-Ling; Shang, Yue; Zhang, Bao-Xian

    2017-04-01

    In this paper, the status of adjuvant standard for Chinese materia medica processing in the Chinese Pharmacopoeia 2015 edition, the National Specification of Chinese Materia Medica Processing, and the 29 provincial specification of Chinese materia medica was summarized, and the the status including general requirements, specific requirements, and quality standard in the three grade official specifications was collected and analyzed according to the "medicine-adjuvant homology" and "food-adjuvant homology" features of adjuvants. This paper also introduced the research situation of adjuvant standard for Chinese materia medica processing in China; In addition, analyzed and discussed the problems existing in the standard system of adjuvant for Chinese materia medica processing, such as lack of general requirements, low level of standard, inconsistent standard references, and lack of research on the standard, and provided suggestions for the further establishment of the national standards system of adjuvant for Chinese materia medica processing. Copyright© by the Chinese Pharmaceutical Association.

  4. Meeting the measurement uncertainty and traceability requirements of ISO/AEC standard 17025 in chemical analysis.

    PubMed

    King, B

    2001-11-01

    The new laboratory accreditation standard, ISO/IEC 17025, reflects current thinking on good measurement practice by requiring more explicit and more demanding attention to a number of activities. These include client interactions, method validation, traceability, and measurement uncertainty. Since the publication of the standard in 1999 there has been extensive debate about its interpretation. It is the author's view that if good quality practices are already in place and if the new requirements are introduced in a manner that is fit for purpose, the additional work required to comply with the new requirements can be expected to be modest. The paper argues that the rigour required in addressing the issues should be driven by customer requirements and the factors that need to be considered in this regard are discussed. The issues addressed include the benefits, interim arrangements, specifying the analytical requirement, establishing traceability, evaluating the uncertainty and reporting the information.

  5. Oral Proficiency Standards and Foreign Language Teacher Candidates: Current Findings and Future Research Directions

    ERIC Educational Resources Information Center

    Glisan, Eileen W.; Swender, Elvira; Surface, Eric A.

    2013-01-01

    The renewed national focus on teacher quality and effectiveness has resulted in more rigorous standards that describe the knowledge and skills required of teacher candidates across all disciplines. In the area of foreign languages, three sets of professional standards address the oral proficiency of teachers in the target languages they teach…

  6. Information System Life-Cycle And Documentation Standards (SMAP DIDS)

    NASA Technical Reports Server (NTRS)

    1990-01-01

    Although not computer program, SMAP DIDS written to provide systematic, NASA-wide structure for documenting information system development projects. Each DID (data item description) outlines document required for top-quality software development. When combined with management, assurance, and life cycle standards, Standards protect all parties who participate in design and operation of new information system.

  7. STEM Education on a Worldwide Voyage: Curriculum to College, Career, and Community Readiness

    ERIC Educational Resources Information Center

    Furuto, Linda H. L.

    2015-01-01

    This article addresses issues in equitable and quality STEM education, and comes at a significant time as students, educators, and policymakers strive to meet federal and state standards such as the Mathematics Common Core State Standards (CCSS) and Next Generation Science Standards (NGSS). CCSS and NGSS require significantly higher levels of…

  8. Meeting the Solid Wood Needs of the Furniture and Cabinet Industries: Standard-Size Hardwood Blanks

    Treesearch

    Philip A. Araman; Charles J Gatchell; Hugh W. Reynolds

    1982-01-01

    Standard-size, kiln-dried hardwood blanks (panels) of specified lengths, widths, thicknesses, and qualities can be used instead of lumber to produce rough dimension furniture parts. Standard sizes were determined by analyzing thousands of part requirements from 20 furniture and 12 kitchen cabinet companies. The International Woodworking Machinery and Furniture Supply...

  9. Development of reclaimed potable water quality criteria

    NASA Technical Reports Server (NTRS)

    Flory, D. A.; Weir, F. W.

    1979-01-01

    In order to minimize launch requirements necessary to meet the demands of long-term spaceflight, NASA will reuse water reclaimed from various on-board sources including urine, feces, wash water and humidity condensate. Development of reclamation systems requires the promulgation of water quality standards for potable reuse of the reclaimed water. Existing standards for domestic U.S. potable water consumption were developed, but do not consider the peculiar problems associated with the potable reuse of recycled water. An effort was made to: (1) define a protocol by which comprehensive reclaimed water potability/palatability criteria can be established and updated; and (2) continue the effort to characterize the organic content of reclaimed water in the Regenerative Life Support Evaluation.

  10. 43 CFR 3802.3-2 - Requirements for environmental protection.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... prevent adverse impact upon plants, fish, and wildlife, including threatened or endangered species, and... GENERAL MINING LAWS Exploration and Mining, Wilderness Review Program § 3802.3-2 Requirements for... quality standards, including the requirements of the Clean Air Act (42 U.S.C. 1857 et seq.). (b) Water...

  11. 43 CFR 3802.3-2 - Requirements for environmental protection.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... prevent adverse impact upon plants, fish, and wildlife, including threatened or endangered species, and... GENERAL MINING LAWS Exploration and Mining, Wilderness Review Program § 3802.3-2 Requirements for... quality standards, including the requirements of the Clean Air Act (42 U.S.C. 1857 et seq.). (b) Water...

  12. 43 CFR 3802.3-2 - Requirements for environmental protection.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... prevent adverse impact upon plants, fish, and wildlife, including threatened or endangered species, and... GENERAL MINING LAWS Exploration and Mining, Wilderness Review Program § 3802.3-2 Requirements for... quality standards, including the requirements of the Clean Air Act (42 U.S.C. 1857 et seq.). (b) Water...

  13. 43 CFR 3802.3-2 - Requirements for environmental protection.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... prevent adverse impact upon plants, fish, and wildlife, including threatened or endangered species, and... GENERAL MINING LAWS Exploration and Mining, Wilderness Review Program § 3802.3-2 Requirements for... quality standards, including the requirements of the Clean Air Act (42 U.S.C. 1857 et seq.). (b) Water...

  14. 78 FR 16184 - Revision to Ambient Nitrogen Dioxide Monitoring Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... Revision to Ambient Nitrogen Dioxide Monitoring Requirements AGENCY: Environmental Protection Agency (EPA... ambient air quality standard (NAAQS) for nitrogen dioxide (NO 2 ) for the near-road component of the NO 2... Nitrogen Dioxide Monitoring Requirements Docket, Docket ID No. EPA-HQ-OAR-2012- 0486, EPA Docket Center...

  15. 40 CFR 51.1007 - Attainment demonstration and modeling requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... requirements. 51.1007 Section 51.1007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Implementation of PM2.5 National Ambient Air Quality Standards § 51.1007 Attainment demonstration and modeling requirements. (a) For any area designated as nonattainment for the PM2.5 NAAQS, the State must submit an...

  16. 40 CFR 51.1007 - Attainment demonstration and modeling requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... requirements. 51.1007 Section 51.1007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Implementation of PM2.5 National Ambient Air Quality Standards § 51.1007 Attainment demonstration and modeling requirements. (a) For any area designated as nonattainment for the PM2.5 NAAQS, the State must submit an...

  17. 40 CFR 51.1007 - Attainment demonstration and modeling requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... requirements. 51.1007 Section 51.1007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Implementation of PM2.5 National Ambient Air Quality Standards § 51.1007 Attainment demonstration and modeling requirements. (a) For any area designated as nonattainment for the PM2.5 NAAQS, the State must submit an...

  18. 40 CFR 51.1011 - Requirements for mid-course review.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Requirements for mid-course review. 51.1011 Section 51.1011 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... PM2.5 National Ambient Air Quality Standards § 51.1011 Requirements for mid-course review. (a) Any...

  19. 40 CFR 51.1011 - Requirements for mid-course review.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Requirements for mid-course review. 51.1011 Section 51.1011 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... PM2.5 National Ambient Air Quality Standards § 51.1011 Requirements for mid-course review. (a) Any...

  20. 40 CFR 51.1007 - Attainment demonstration and modeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... requirements. 51.1007 Section 51.1007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Implementation of PM2.5 National Ambient Air Quality Standards § 51.1007 Attainment demonstration and modeling requirements. (a) For any area designated as nonattainment for the PM2.5 NAAQS, the State must submit an...

  1. 40 CFR 51.1011 - Requirements for mid-course review.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Requirements for mid-course review. 51.1011 Section 51.1011 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... PM2.5 National Ambient Air Quality Standards § 51.1011 Requirements for mid-course review. (a) Any...

  2. 40 CFR 125.68 - Special conditions for section 301(h) modified permits.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS CRITERIA AND STANDARDS FOR THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM Criteria for Modifying the Secondary Treatment Requirements Under Section 301(h) of the Clean Water Act...: (1) Biomonitoring requirements of § 125.63(b); (2) Water quality requirements of § 125.63(c); (3...

  3. 40 CFR 125.68 - Special conditions for section 301(h) modified permits.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) WATER PROGRAMS CRITERIA AND STANDARDS FOR THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM Criteria for Modifying the Secondary Treatment Requirements Under Section 301(h) of the Clean Water Act...: (1) Biomonitoring requirements of § 125.63(b); (2) Water quality requirements of § 125.63(c); (3...

  4. 40 CFR 51.1012 - Requirement for contingency measures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Requirement for contingency measures... Implementation of PM2.5 National Ambient Air Quality Standards § 51.1012 Requirement for contingency measures... contingency measures to be undertaken if the area fails to make reasonable further progress, or fails to...

  5. Harmonization of good laboratory practice requirements and laboratory accreditation programs.

    PubMed

    Royal, P D

    1994-09-01

    Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

  6. [Quality standards for epidemiologic cohort studies : An evaluated catalogue of requirements for the conduct and preparation of cohort studies].

    PubMed

    Schmidt, Carsten Oliver; Krabbe, Christine E M; Schössow, Janka; Berger, Klaus; Enzenbach, Cornelia; Kamtsiuris, Panagiotis; Schöne, Gina; Houben, Robin; Meisinger, Christa; Bamberg, Fabian; Hendel, Thomas; Selder, Sonja; Nonnemacher, Michael; Moebus, Susanne; Stausberg, Jürgen

    2018-01-01

    Cohort studies are a longitudinal observational study type. They are firmly established within epidemiology to assess the course of diseases and risk factors. Yet, standards to describe and evaluate quality characteristics of cohort studies need further development. Within the TMF ("Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.") project "Quality management standards in cohort studies", a catalogue of requirements was compiled and evaluated, focusing on the preparation and conduct of epidemiologic cohort studies. The catalogue of requirements was established based on a consensus process between representatives of seven German epidemiologic cohort studies. For this purpose, a set of expert meetings (telephone, face-to-face, web-based) was conducted and the importance of each element of the catalogue was assessed as well as its implementation. A catalogue of requirements with 138 requirements was consented. It is structured into ten sections: 1. Study documentation; 2. Selection of instruments; 3. Study implementation, 4. Organizational structure; 5. Qualification and certification; 6. Participant recruitment; 7. Preparation, conduct and follow-up processing of examinations; 8. Study logistics and maintenance, 9. Data capture and data management; 10. Reporting and monitoring. In total, 41 elements were categorized as being essential, 91 as important, and 6 as less important. The catalogue of requirements provides a guideline to improve the preparation and operation of cohort studies. The evaluation of the importance and degree of implementation of requirements depended on the study design. With adaptations, the catalogue might be transferable to other study types.

  7. Satellite-Friendly Protocols and Standards

    NASA Astrophysics Data System (ADS)

    Koudelka, O.; Schmidt, M.; Ebert, J.; Schlemmer, H.; Kastner, S.; Riedler, W.

    2002-01-01

    We are currently observing a development unprecedented with other services, the enormous growth of the Internet. Video, voice and data applications can be supported via this network in high quality. Multi-media applications require high bandwidth which may not be available in many areas. When making proper use of the broadcast feature of a communications satellite, the performance of the satellite-based system can compare favourably to terrestrial solutions. Internet applications are in many cases highly asymmetric, making them very well suited to applications using small and inexpensive terminals. Data from one source may be used simultaneously by a large number of users. The Internet protocol suite has become the de-facto standard. But this protocol family in its original form has not been designed to support guaranteed quality of service, a prerequisite for real-time, high quality traffic. The Internet Protocol has to be adapted for the satellite environment, because long roundtrip delays and the error behaviour of the channel could make it inefficient over a GEO satellite. Another requirement is to utilise the satellite bandwidth as efficiently as possible. This can be achieved by adapting the access system to the nature of IP frames, which are variable in length. In the framework of ESA's ARTES project a novel satellite multimedia system was developed which utilises Multi-Frequency TDMA in a meshed network topology. The system supports Quality of Service (QoS) by reserving capacity with different QoS requirements. The system is centrally controlled by a master station with the implementation of a demand assignment (DAMA) system. A lean internal signalling system has been adopted. Network management is based on the SNMP protocol and industry-standard network management platforms, making interfaces to standard accounting and billing systems easy. Modern communication systems will have to be compliant to different standards in a very flexible manner. The developed system is based on a hardware architecture using FPGAs (Field-Programmable Gate Arrays). This provides means to configure the satellite gateway for different standards and to optimise the transmission parameters for varying user traffic, thus increasing the efficiency significantly. The paper describes the flexible system architecture and focuses particularly on the DAMA access scheme and the chosen quality-of-service implementation. Emphasis has been put on the support of IP Version 6. Different standards (e.g. RCS and possible follow-ups) and the possibility to support them are discussed.

  8. American Osteopathic Association Commitment to Quality and Lifelong Learning

    ERIC Educational Resources Information Center

    Tunanidas, Amelia G.; Burkhart, Diane N.

    2005-01-01

    The American Osteopathic Association (AOA) initiated programs to enhance quality for 54, 000 doctors of osteopathic medicine (DOs) practicing in the United States. Seven core competencies are required in undergraduate and graduate medical education standards. They include osteopathic philosophy and osteopathic manipulative medicine, medical…

  9. 75 FR 60013 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compounds Emissions... Maryland's Volatile Organic Compounds from Specific Processes Regulation. Maryland has adopted standards... (RACT) requirements for sources of volatile organic compounds (VOCs) covered by control techniques...

  10. NO2 NAAQS Review: Policy Assessment

    EPA Science Inventory

    NO2 is one of the six major air pollutants for which EPA has issued air quality criteria and established national ambient air quality standards (NAAQS) based on those criteria. The Clean Air Act (CAA) requires EPA to periodically review and revise, as appropriate, existing air qu...

  11. Fact Sheets and Additional Information Regarding the Primary National Ambient Air Quality Standards (NAAQS) for Nitrogen Dioxide (NO2)

    EPA Pesticide Factsheets

    Find tools for primary standards for Nitrogen Dioxide, maps of monitoring areas, an overview of the proposal, monitor requirements, design values for counties, and a presentation on the 2010 NO2 primary NAAQS revision.

  12. The Economic Impact on the Construction Industry of Additional Demands Caused by New Environmental Protection Standards (1972)

    EPA Pesticide Factsheets

    New facilities and additions to existing facilities will be required to meet the EPA's new (early 1970s) environmental quality standards. The report examines extent of these additional demands for construction and their economic impacts.

  13. 76 FR 19292 - Approval and Promulgation of Implementation Plans; Oregon; Interstate Transport of Pollution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-07

    ...EPA is proposing to approve a portion of the State Implementation Plan (SIP) revision submitted by the State of Oregon for the purpose of addressing the interstate transport provisions of Clean Air Act (CAA) section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and the 1997 fine particulate matter (PM2.5) NAAQS. Section 110(a)(2)(D)(i) of the CAA requires that each State have adequate provisions to prohibit air emissions from adversely affecting air quality in other States through interstate transport. EPA is proposing to approve Oregon's SIP revision for the 1997 8-hour ozone and 1997 PM2.5 NAAQS as meeting the requirements of CAA section 110(a)(2)(D)(i)(I) to prohibit emissions that will contribute significantly to nonattainment of the these standards in any other State and to prohibit emissions that will interfere with maintenance of these standards by any other State.

  14. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

    PubMed

    Kroes, Burt H

    2014-12-02

    In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Optimization of Collision Detection in Surgical Simulations

    NASA Astrophysics Data System (ADS)

    Custură-Crăciun, Dan; Cochior, Daniel; Neagu, Corneliu

    2014-11-01

    Just like flight and spaceship simulators already represent a standard, we expect that soon enough, surgical simulators should become a standard in medical applications. A simulations quality is strongly related to the image quality as well as the degree of realism of the simulation. Increased quality requires increased resolution, increased representation speed but more important, a larger amount of mathematical equations. To make it possible, not only that we need more efficient computers, but especially more calculation process optimizations. A simulator executes one of the most complex sets of calculations each time it detects a contact between the virtual objects, therefore optimization of collision detection is fatal for the work-speed of a simulator and hence in its quality

  16. Beam uniformity of flat top lasers

    NASA Astrophysics Data System (ADS)

    Chang, Chao; Cramer, Larry; Danielson, Don; Norby, James

    2015-03-01

    Many beams that output from standard commercial lasers are multi-mode, with each mode having a different shape and width. They show an overall non-homogeneous energy distribution across the spot size. There may be satellite structures, halos and other deviations from beam uniformity. However, many scientific, industrial and medical applications require flat top spatial energy distribution, high uniformity in the plateau region, and complete absence of hot spots. Reliable standard methods for the evaluation of beam quality are of great importance. Standard methods are required for correct characterization of the laser for its intended application and for tight quality control in laser manufacturing. The International Organization for Standardization (ISO) has published standard procedures and definitions for this purpose. These procedures have not been widely adopted by commercial laser manufacturers. This is due to the fact that they are unreliable because an unrepresentative single-pixel value can seriously distort the result. We hereby propose a metric of beam uniformity, a way of beam profile visualization, procedures to automatically detect hot spots and beam structures, and application examples in our high energy laser production.

  17. Improving data quality in the linked open data: a survey

    NASA Astrophysics Data System (ADS)

    Hadhiatma, A.

    2018-03-01

    The Linked Open Data (LOD) is “web of data”, a different paradigm from “web of document” commonly used today. However, the huge LOD still suffers from data quality problems such as completeness, consistency, and accuracy. Data quality problems relate to designing effective methods both to manage and to retrieve information at various data quality levels. Based on review from papers and journals, addressing data quality requires some standards functioning to (1) identification of data quality problems, (2) assessment of data quality for a given context, and (3) correction of data quality problems. However, mostly the methods and strategies dealing with the LOD data quality were not as an integrative approach. Hence, based on those standards and an integrative approach, there are opportunities to improve the LOD data quality in the term of incompleteness, inaccuracy and inconsistency, considering to its schema and ontology, namely ontology refinement. Moreover, the term of the ontology refinement means that it copes not only to improve data quality but also to enrich the LOD. Therefore, it needs (1) a standard for data quality assessment and evaluation which is more appropriate to the LOD; (2) a framework of methods based on statistical relational learning that can improve the correction of data quality problems as well as enrich the LOD.

  18. KSC Center Director Bridges accepts an ISO 9001 certification plaque from DNV

    NASA Technical Reports Server (NTRS)

    1998-01-01

    Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world- class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

  19. KSC-98pc909

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges speaks to KSC employees at the ISO certification ceremony held at the Training Auditorium. Bridges was presented an ISO 9001 certificate and plaque awarded to KSC by Det Norske Veritas (DNV), Inc., an international ISO certification organization. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification. Next to Bridges is Heidi Hollingsworth, with the Center for Independent Living, who uses American Sign Language for any hearing-impaired employees in the audience

  20. Solving the Problem: Genome Annotation Standards before the Data Deluge.

    PubMed

    Klimke, William; O'Donovan, Claire; White, Owen; Brister, J Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D; Tatusova, Tatiana

    2011-10-15

    The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries.

  1. Solving the Problem: Genome Annotation Standards before the Data Deluge

    PubMed Central

    Klimke, William; O'Donovan, Claire; White, Owen; Brister, J. Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D.; Tatusova, Tatiana

    2011-01-01

    The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries. PMID:22180819

  2. Quality specifications for articles of botanical origin from the United States Pharmacopeia.

    PubMed

    Ma, Cuiying; Oketch-Rabah, Hellen; Kim, Nam-Cheol; Monagas, Maria; Bzhelyansky, Anton; Sarma, Nandakumara; Giancaspro, Gabriel

    2018-06-01

    In order to define appropriate quality of botanical dietary supplements, botanical drugs, and herbal medicines, the United States Pharmacopeia (USP) and the Herbal Medicines Compendium (HMC) contain science-based quality standards that include multiple interrelated tests to provide a full quality characterization for each article in terms of its identity, purity, and content. To provide a comprehensive description of the pharmacopeial tests and requirements for articles of botanical origin in the aforementioned compendia. Selective chromatographic procedures, such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC), are used as Identification tests in pharmacopeial monographs to detect species substitution or other confounders. HPLC quantitative tests are typically used to determine the content of key constituents, i.e., the total or individual amount of plant secondary metabolites that are considered bioactive constituents or analytical marker compounds. Purity specifications are typically set to limit the content of contaminants such as toxic elements, pesticides, and fungal toxins. Additional requirements highlight the importance of naming, definition, use of reference materials, and packaging/storage conditions. Technical requirements for each section of the monographs were illustrated with specific examples. Tests were performed on authentic samples using pharmacopeial reference standards. The chromatographic analytical procedures were validated to provide characteristic profiles for the identity and/or accurate determination of the content of quality markers. The multiple tests included in each monograph complement each other to provide an appropriate pharmacopeial quality characterization for the botanicals used as herbal medicines and dietary supplements. The monographs provide detailed specifications for identity, content of bioactive constituents or quality markers, and limits of contaminants, adulterants, and potentially toxic substances. Additional requirements such as labeling and packaging further contribute to preserve the quality of these products. Compliance with pharmacopeial specifications should be required to ensure the reliability of botanical articles used for health care purposes. Copyright © 2018. Published by Elsevier GmbH.

  3. A web tool for STORET/WQX water quality data retrieval and Best Management Practice scenario suggestion.

    PubMed

    Park, Youn Shik; Engel, Bernie A; Kim, Jonggun; Theller, Larry; Chaubey, Indrajeet; Merwade, Venkatesh; Lim, Kyoung Jae

    2015-03-01

    Total Maximum Daily Load is a water quality standard to regulate water quality of streams, rivers and lakes. A wide range of approaches are used currently to develop TMDLs for impaired streams and rivers. Flow and load duration curves (FDC and LDC) have been used in many states to evaluate the relationship between flow and pollutant loading along with other models and approaches. A web-based LDC Tool was developed to facilitate development of FDC and LDC as well as to support other hydrologic analyses. In this study, the FDC and LDC tool was enhanced to allow collection of water quality data via the web and to assist in establishing cost-effective Best Management Practice (BMP) implementations. The enhanced web-based tool provides use of water quality data not only from the US Geological Survey but also from the Water Quality Portal for the U.S. via web access. Moreover, the web-based tool identifies required pollutant reductions to meet standard loads and suggests a BMP scenario based on ability of BMPs to reduce pollutant loads, BMP establishment and maintenance costs. In the study, flow and water quality data were collected via web access to develop LDC and to identify the required reduction. The suggested BMP scenario from the web-based tool was evaluated using the EPA Spreadsheet Tool for the Estimation of Pollutant Load model to attain the required pollutant reduction at least cost. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Products cooked in preheated versus non-preheated ovens. Baking times, calculated energy consumption, and product quality compared.

    PubMed

    Odland, D; Davis, C

    1982-08-01

    Plain muffins, yellow cake, baked custard, apple pie, tuna casserole, frozen tuna casserole, cheese soufflé, and meat loaf were baked in preheated and non-preheated standard gas, continuous-clean gas, standard electric, and self-cleaning electric ovens. Products generally required 5 min. or less extra baking time when cooked in non-preheated rather than in preheated ovens. The variability in baking times often was less between preheated and non-preheated ovens than among oven types. Calculated energy consumption values showed that usually less energy was required to bake products in non-preheated than in preheated ovens; savings averaged about 10 percent. Few significant differences were found in physical measurements or eating quality either between preheated and non-preheated ovens or among oven types. Overall, for the products tested, findings confirmed that preheating the oven is not essential for good product quality and, therefore, is an unnecessary use of energy.

  5. DCSC (Defense Construction Supply Center) Total Quality Management Master Plan

    DTIC Science & Technology

    1989-07-01

    job while allowing them to establish a better balance between work and personal needs. 29 TQM SHORT-MID-LONG RANGE INITIATIVES MID RANGE (3 YEARS...all performance standards. IMPROVE THE QUALITY OF WORKLIFE - Projects requiring engineering support throughout FY 90 and beyond are: Construction of

  6. Characterizing the Exposure of Regional-Scale Air Quality in the Northeastern United States

    EPA Science Inventory

    The Clean Air Act (CAA) requires that the United States (U.S.) Environmental Protection Agency (EPA) set National Ambient Air Quality Standards (NAAQS) for pollutants considered harmful to human health and the environment. Previous research has shown that high ambient ozone leve...

  7. 38 CFR 36.4348 - Servicer Appraisal Processing Program.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

  8. 38 CFR 36.4348 - Servicer Appraisal Processing Program.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

  9. 38 CFR 36.4348 - Servicer Appraisal Processing Program.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

  10. 38 CFR 36.4348 - Servicer Appraisal Processing Program.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

  11. Expert database system for quality control

    NASA Astrophysics Data System (ADS)

    Wang, Anne J.; Li, Zhi-Cheng

    1993-09-01

    There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

  12. VARED: Verification and Analysis of Requirements and Early Designs

    NASA Technical Reports Server (NTRS)

    Badger, Julia; Throop, David; Claunch, Charles

    2014-01-01

    Requirements are a part of every project life cycle; everything going forward in a project depends on them. Good requirements are hard to write, there are few useful tools to test, verify, or check them, and it is difficult to properly marry them to the subsequent design, especially if the requirements are written in natural language. In fact, the inconsistencies and errors in the requirements along with the difficulty in finding these errors contribute greatly to the cost of the testing and verification stage of flight software projects [1]. Large projects tend to have several thousand requirements written at various levels by different groups of people. The design process is distributed and a lack of widely accepted standards for requirements often results in a product that varies widely in style and quality. A simple way to improve this would be to standardize the design process using a set of tools and widely accepted requirements design constraints. The difficulty with this approach is finding the appropriate constraints and tools. Common complaints against the tools available include ease of use, functionality, and available features. Also, although preferable, it is rare that these tools are capable of testing the quality of the requirements.

  13. Deriving Chesapeake Bay Water Quality Standards

    USGS Publications Warehouse

    Tango, Peter J.; Batiuk, Richard A.

    2013-01-01

    Achieving and maintaining the water quality conditions necessary to protect the aquatic living resources of the Chesapeake Bay and its tidal tributaries has required a foundation of quantifiable water quality criteria. Quantitative criteria serve as a critical basis for assessing the attainment of designated uses and measuring progress toward meeting water quality goals of the Chesapeake Bay Program partnership. In 1987, the Chesapeake Bay Program partnership committed to defining the water quality conditions necessary to protect aquatic living resources. Under section 303(c) of the Clean Water Act, States and authorized tribes have the primary responsibility for adopting water quality standards into law or regulation. The Chesapeake Bay Program partnership worked with U.S. Environmental Protection Agency to develop and publish a guidance framework of ambient water quality criteria with designated uses and assessment procedures for dissolved oxygen, water clarity, and chlorophyll a for Chesapeake Bay and its tidal tributaries in 2003. This article reviews the derivation of the water quality criteria, criteria assessment protocols, designated use boundaries, and their refinements published in six addendum documents since 2003 and successfully adopted into each jurisdiction's water quality standards used in developing the Chesapeake Bay Total Maximum Daily Load.

  14. Guidelines for External Reviews of Quality Assurance Agencies in the European Higher Education Area. ENQA Occasional Papers 19

    ERIC Educational Resources Information Center

    ENQA (European Association for Quality Assurance in Higher Education), 2012

    2012-01-01

    In accordance with the ENQA (European Association for Quality Assurance in Higher Education) membership criteria laid down in the Statutes of ENQA, member agencies are required to undergo external reviews against the membership criteria, and thereby the Standards and Guidelines for Quality Assurance in the European Higher Education Area (ESG) as…

  15. Water Quality of Hills Water, Supply Water and RO Water Machine at Ulu Yam Selangor

    NASA Astrophysics Data System (ADS)

    Ngadiman, N.; ‘I Bahari, N.; Kaamin, M.; Hamid, N. B.; Mokhtar, M.; Sahat, S.

    2016-07-01

    The rapid development resulted in the deterioration of the quality of drinking water in Malaysia. Recognizing the importance of water quality, new alternatives for drinking water such as mineral water processing from reverse osmosis (RO) machine become more popular. Hence, the demand for mineral water, natural spring water or water from the hills or mountains rose lately. More consumers believed the quality of these spring water better than other source of drinking water. However, the quality of all the drinking water sources is to meet the required quality standard. Therefore, this paper aims to measure the quality of the waters from hills, from RO machine and the water supply in Ulu Yam, Selangor Batang Kali, Malaysia. The water quality was determined based on following parameters: ammoniacal nitrogen (NH3), iron (Fe), turbidity (NTU) and pH. The results show that the water from hills has better quality compared to water supply and water from RO machine. The value of NH3 ranged from 0.03 mg/L- 0.67 mg/L; Fe was from 0.03mg/L - 0.12 mg/L, turbidity at 0.42 NTU - 0.88 NTU and pH is at 6.60 - 0.71. Based on the studied parameters, all three types of water are fit for drinking and have met the required national drinking water quality standard.

  16. Standard requirements for GCP-compliant data management in multinational clinical trials

    PubMed Central

    2011-01-01

    Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. Conclusions The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres. PMID:21426576

  17. Quality standards for bone conduction implants.

    PubMed

    Gavilan, Javier; Adunka, Oliver; Agrawal, Sumit; Atlas, Marcus; Baumgartner, Wolf-Dieter; Brill, Stefan; Bruce, Iain; Buchman, Craig; Caversaccio, Marco; De Bodt, Marc T; Dillon, Meg; Godey, Benoit; Green, Kevin; Gstoettner, Wolfgang; Hagen, Rudolf; Hagr, Abdulrahman; Han, Demin; Kameswaran, Mohan; Karltorp, Eva; Kompis, Martin; Kuzovkov, Vlad; Lassaletta, Luis; Li, Yongxin; Lorens, Artur; Martin, Jane; Manoj, Manikoth; Mertens, Griet; Mlynski, Robert; Mueller, Joachim; O'Driscoll, Martin; Parnes, Lorne; Pulibalathingal, Sasidharan; Radeloff, Andreas; Raine, Christopher H; Rajan, Gunesh; Rajeswaran, Ranjith; Schmutzhard, Joachim; Skarzynski, Henryk; Skarzynski, Piotr; Sprinzl, Georg; Staecker, Hinrich; Stephan, Kurt; Sugarova, Serafima; Tavora, Dayse; Usami, Shin-Ichi; Yanov, Yuri; Zernotti, Mario; Zorowka, Patrick; de Heyning, Paul Van

    2015-01-01

    Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

  18. Standardized Estimates of Time Required and Quality of Various Tasks in Household Employment. Final Report.

    ERIC Educational Resources Information Center

    Vaughn, Janet L.

    The pricing of household work can be based on standardized times established for component parts of the job. Techniques for determining these standardized times and the component parts were developed in a study conducted at Purdue University and supported by a federal grant. After a preliminary survey of homemaker practices in cleaning living…

  19. The Council on Accreditation of Park, Recreation, Tourism, and Related Professions: 2013 Standards-- The Importance of Outcome-Based Assessment and the Connection to Student Learning

    ERIC Educational Resources Information Center

    Blazey, Michael A.

    2014-01-01

    The Council for Higher Education Accreditation (CHEA) adopted recognition standards in 2006 requiring regional and professional accreditors such as the Council on Accreditation of Park, Recreation, Tourism, and Related Professions (COAPRT) to adopt standards and practices advancing academic quality, demonstrating accountability, and encouraging…

  20. 76 FR 59090 - Approval and Promulgation of Implementation Plans; Oregon: New Source Review/Prevention of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ...EPA is proposing to approve a portion of the State Implementation Plan (SIP) revision submitted by the State of Oregon for the purpose of addressing the third element of the interstate transport provisions of Clean Air Act (CAA or the Act) section 110(a)(2)(D)(i)(II) for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and the 1997 and 2006 fine particulate matter (PM2.5) NAAQS. The third element of CAA section 110(a)(2)(D)(i)(II) requires that a State not interfere with any other State's required measures to prevent significant deterioration (PSD) of its air quality. EPA is also proposing to approve numerous revisions to the Oregon SIP that were submitted to EPA by the State of Oregon on October 8, 2008; October 10, 2008; March 17, 2009; June 23, 2010; December 22, 2010 and May 5, 2011. The revisions include updating Oregon's new source review (NSR) rules to be consistent with current Federal regulations and streamlining Oregon's air quality rules by clarifying requirements, removing duplicative rules, and correcting errors. The revisions were submitted in accordance with the requirements of section 110 and part D of the Act).

  1. 77 FR 71568 - Approval and Promulgation of Implementation Plans; Tennessee; Interstate Transport Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... Promulgation of Implementation Plans; Tennessee; Interstate Transport Infrastructure Requirements (Prevention of Significant Deterioration) for the 2008 8-Hour Ozone National Ambient Air Quality Standards AGENCY... Clean Air Act (CAA) requirements pertaining to prevention of significant deterioration (PSD) (concerning...

  2. 10 CFR 72.122 - Overall requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... § 72.122 Overall requirements. (a) Quality Standards. Structures, systems, and components important to... natural phenomena. (1) Structures, systems, and components important to safety must be designed to... accidents. (2)(i) Structures, systems, and components important to safety must be designed to withstand the...

  3. Alternative Renewable Biomass Tracking Program Document under the Renewable Fuel Standard Program

    EPA Pesticide Factsheets

    The approval letters that EPA approves a company's biomass tracking program meeting all the requirements outlined in 40 CFR part 80.1454, including elements determined necessary to achieve the level of quality assurance required under the regulation list.

  4. Elevating the quality of disability and rehabilitation research: mandatory use of the reporting guidelines.

    PubMed

    Chan, Leighton; Heinemann, Allen W; Roberts, Jason

    2014-01-01

    Note from the AJOT Editor-in-Chief: Since 2010, the American Journal of Occupational Therapy (AJOT) has adopted reporting standards based on the Consolidated Standards of Reporting Trials (CONSORT) Statement and American Psychological Association (APA) guidelines in an effort to publish transparent clinical research that can be easily evaluated for methodological and analytical rigor (APA Publications and Communications Board Working Group on Journal Article Reporting Standards, 2008; Moher, Schulz, & Altman, 2001). AJOT has now joined 28 other major rehabilitation and disability journals in a collaborative initiative to enhance clinical research reporting standards through adoption of the EQUATOR Network reporting guidelines, described below. Authors will now be required to use these guidelines in the preparation of manuscripts that will be submitted to AJOT. Reviewers will also use these guidelines to evaluate the quality and rigor of all AJOT submissions. By adopting these standards we hope to further enhance the quality and clinical applicability of articles to our readers. Copyright © 2014 by the American Occupational Therapy Association, Inc.

  5. A PRELIMINARY EVALUATION OF MODELS-3 CMAQ USING PARTICULATE MATTER DATA FROM THE IMPROVE NETWORK

    EPA Science Inventory

    The Clean Air Act and its Amendments require the United States Environmental Protection Agency (EPA) to establish National Ambient Air Quality Standards for Particulate Matter (PM) and to assess current and future air quality regulations designed to protect human health and wel...

  6. Faculty Sufficiency and AACSB Accreditation Compliance within a Global University: A Mathematical Modeling Approach

    ERIC Educational Resources Information Center

    Boronico, Jess; Murdy, Jim; Kong, Xinlu

    2014-01-01

    This manuscript proposes a mathematical model to address faculty sufficiency requirements towards assuring overall high quality management education at a global university. Constraining elements include full-time faculty coverage by discipline, location, and program, across multiple campus locations subject to stated service quality standards of…

  7. 21 CFR 900.4 - Standards for accreditation bodies.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images... review by the accreditation body demonstrates that a problem does exist with respect to image quality or... program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure...

  8. 21 CFR 900.4 - Standards for accreditation bodies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images... review by the accreditation body demonstrates that a problem does exist with respect to image quality or... program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure...

  9. 21 CFR 900.4 - Standards for accreditation bodies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images... review by the accreditation body demonstrates that a problem does exist with respect to image quality or... program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure...

  10. 21 CFR 900.4 - Standards for accreditation bodies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images... review by the accreditation body demonstrates that a problem does exist with respect to image quality or... program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure...

  11. 9 CFR 381.21 - Refusal of inspection.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless... required in connection with an application for inspection granted after April 3, 1970, for facilities...

  12. 75 FR 62401 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ... collection; Title of Information Collection: Clinical Laboratory Improvement Amendment (CLIA) of 1988 and... laboratories that perform testing on human beings to meet performance requirements (quality standards) in order... functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity...

  13. 42 CFR § 512.413 - Quality measures and reporting for SHFFT model.

    Code of Federal Regulations, 2010 CFR

    2017-10-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS EPISODE PAYMENT MODEL... 42 Public Health 5 2017-10-01 2017-10-01 false Quality measures and reporting for SHFFT model. Â... reporting for SHFFT model. (a) Required measures. (1) Hospital-Level Risk-Standardized Complication Rate...

  14. Quality control ranges for testing broth microdilution susceptibility of Flavobacterium columnare and F. psychrophilium to nine antimicrobials

    USDA-ARS?s Scientific Manuscript database

    A multi-laboratory broth microdilution method trial was performed to standardize the specialized test conditions required for fish pathogens Flavobacterium columnare and F. pyschrophilum. Nine laboratories tested the quality control (QC) strains Escherichia coli ATCC 25922 and Aeromonas salmonicid...

  15. Role of Clinical Practice in Teacher Preparation: Perceptions of Elementary Teacher Candidates

    ERIC Educational Resources Information Center

    Singh, Delar K.

    2017-01-01

    The Council for Accreditation of Teacher Education Programs (CAEP) has established five standards to measure the effectiveness of teacher preparation programs. Clinical partnerships and practice represent "Standard 2." The CAEP requires that teacher education programs design high quality clinical practice that is central to preparation…

  16. Potential Predictors of Student Teaching Performance: Considering Emotional Intelligence

    ERIC Educational Resources Information Center

    Hall, P. Cougar; West, Joshua H.

    2011-01-01

    Efforts to increase teacher quality have focused on increasing both the admission and graduation standards required for students entering the profession. This study examined the relationship between common standards, such as college GPA, ACT scores, and Praxis exam scores, with student teacher performance as measured by an assessment rubric based…

  17. Data Acceptance Criteria for Standardized Human-Associated Fecal Source Identification Quantitative Real-Time PCR Methods

    EPA Science Inventory

    There is a growing interest in the application of human-associated fecal sourceidentification quantitative real-time PCR (qPCR) technologies for water quality management. The transition from a research tool to a standardized protocol requires a high degree of confidence in data q...

  18. 75 FR 16837 - Public Review of Draft United States Thoroughfare, Landmark, and Postal Address Data Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... the structure of their address information but have not defined the elements that constitute an address. Knowledge of structure, content, and quality is required to successfully share information in a... discrete elements of address information and provides standardized terminology and definitions to alleviate...

  19. Effects of State Minimum Staffing Standards on Nursing Home Staffing and Quality of Care

    PubMed Central

    Park, Jeongyoung; Stearns, Sally C

    2009-01-01

    Objective To investigate the impact of state minimum staffing standards on the level of staffing and quality of nursing home care. Data Sources Online Survey and Certification Reporting System (OSCAR) merged with the Area Resource File from 1998 through 2001. Study Design Between 1998 and 2001, 16 states implemented or expanded staffing standards in excess of federal requirements, creating a natural experiment in comparison with facilities in states without new standards. Difference-in-differences models using facility fixed effects were estimated to determine the effect of state standards. Data Collection/Extraction Methods OSCAR data were linked to the data on market conditions and state policies. A total of 55,248 facility-year observations from 15,217 freestanding facilities were analyzed. Principal Findings Increased standards resulted in small staffing increases for facilities with staffing initially below or close to new standards. Yet the standards were associated with reductions in restraint use and the number of total deficiencies at all types of facilities. Conclusions Mandated staffing standards affect only low-staff facilities facing potential for penalties, and effects are small. Selected facility-level outcomes may show improvement at all facilities due to a general response to increased standards or to other quality initiatives implemented at the same time as staffing standards. PMID:18823448

  20. Design considerations for computationally constrained two-way real-time video communication

    NASA Astrophysics Data System (ADS)

    Bivolarski, Lazar M.; Saunders, Steven E.; Ralston, John D.

    2009-08-01

    Today's video codecs have evolved primarily to meet the requirements of the motion picture and broadcast industries, where high-complexity studio encoding can be utilized to create highly-compressed master copies that are then broadcast one-way for playback using less-expensive, lower-complexity consumer devices for decoding and playback. Related standards activities have largely ignored the computational complexity and bandwidth constraints of wireless or Internet based real-time video communications using devices such as cell phones or webcams. Telecommunications industry efforts to develop and standardize video codecs for applications such as video telephony and video conferencing have not yielded image size, quality, and frame-rate performance that match today's consumer expectations and market requirements for Internet and mobile video services. This paper reviews the constraints and the corresponding video codec requirements imposed by real-time, 2-way mobile video applications. Several promising elements of a new mobile video codec architecture are identified, and more comprehensive computational complexity metrics and video quality metrics are proposed in order to support the design, testing, and standardization of these new mobile video codecs.

  1. 33 CFR 337.2 - State requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... to achieve consistency to the maximum degree practicable with an approved coastal zone management... be made aware that additional costs to meet state standards or the requirements of the coastal zone... its intent to deny water quality certification or does not concur regarding coastal zone consistency...

  2. 33 CFR 337.2 - State requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... to achieve consistency to the maximum degree practicable with an approved coastal zone management... be made aware that additional costs to meet state standards or the requirements of the coastal zone... its intent to deny water quality certification or does not concur regarding coastal zone consistency...

  3. 40 CFR 51.900 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... higher or lower, classifications are ranked from lowest to highest as follows: classification under... National Ambient Air Quality Standard § 51.900 Definitions. The following definitions apply for purposes of... 42 U.S.C. 7401-7671q (2003). (f) Applicable requirements means for an area the following requirements...

  4. 40 CFR 51.900 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... higher or lower, classifications are ranked from lowest to highest as follows: classification under... National Ambient Air Quality Standard § 51.900 Definitions. The following definitions apply for purposes of... 42 U.S.C. 7401-7671q (2003). (f) Applicable requirements means for an area the following requirements...

  5. 24 CFR 983.155 - Completion of housing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... with local requirements (such as code and zoning requirements); and (ii) An architect's certification that the housing complies with: (A) HUD housing quality standards; (B) State, local, or other building codes; (C) Zoning; (D) The rehabilitation work write-up (for rehabilitated housing) or the work...

  6. 24 CFR 983.155 - Completion of housing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... with local requirements (such as code and zoning requirements); and (ii) An architect's certification that the housing complies with: (A) HUD housing quality standards; (B) State, local, or other building codes; (C) Zoning; (D) The rehabilitation work write-up (for rehabilitated housing) or the work...

  7. 24 CFR 983.155 - Completion of housing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... with local requirements (such as code and zoning requirements); and (ii) An architect's certification that the housing complies with: (A) HUD housing quality standards; (B) State, local, or other building codes; (C) Zoning; (D) The rehabilitation work write-up (for rehabilitated housing) or the work...

  8. 24 CFR 983.155 - Completion of housing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... with local requirements (such as code and zoning requirements); and (ii) An architect's certification that the housing complies with: (A) HUD housing quality standards; (B) State, local, or other building codes; (C) Zoning; (D) The rehabilitation work write-up (for rehabilitated housing) or the work...

  9. MODELING POTENTIAL PATHOGEN INFECTED WATERS UTILIZING LANDSCAPE INDICES

    EPA Science Inventory

    The federal Clean Water Act (CWA) requires states, territories and tribal lands to assess their waters on a biennial schedule and identify, list and prioritize impaired waters not meeting water quality standards. Once a water body is listed, the state is required to develop Tota...

  10. 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...

  11. 24 CFR 983.155 - Completion of housing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... with local requirements (such as code and zoning requirements); and (ii) An architect's certification that the housing complies with: (A) HUD housing quality standards; (B) State, local, or other building codes; (C) Zoning; (D) The rehabilitation work write-up (for rehabilitated housing) or the work...

  12. Water for haemodialysis and related therapies: recent standards and emerging issues.

    PubMed

    Hoenich, Nicholas A; Levin, Robert; Ronco, Claudio

    2010-01-01

    Dialysis is a well-established and widely used procedure. For a number of years, the focus has been on ensuring that water used in the preparation of dialysis fluid meets the required chemical and microbiological quality and complies with national or international standards which have recently been updated. Continued vigilance is required, in particular when new chemicals such as silver-stabilized hydrogen peroxide and chlorine dioxide are used to prevent growth of Legionella bacteria in hospital water systems, since residues are harmful to patients receiving dialysis. To achieve the required quality, large volumes of water are processed, and a substantial portion is sent to waste via the municipal sewer systems with little attempt to reuse such water on site. In view of concern about global warming and climate change, there is a need to adopt a more environmentally conscious attitude requiring dialysis providers to focus on this aspect of water usage. Copyright (c) 2010 S. Karger AG, Basel.

  13. Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

    PubMed

    Crandall, Phil; Van Loo, Ellen J; O'Bryan, Corliss A; Mauromoustakos, Andy; Yiannas, Frank; Dyenson, Natalie; Berdnik, Irina

    2012-09-01

    International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required improved company food safety practices and increased employee training. Adoption of a GFSI benchmarked scheme resulted in fewer audits, i.e., one less per year. An educational opportunity exists to acquaint retailers and suppliers worldwide with the benefits of having an internationally recognized certification program such as that recognized by the GFSI.

  14. The Students' Viewpoint on Quality of Educational Services in Iran.

    PubMed

    Siamian, Hasan; Rostami, Farideh; Ghara, Aliasghar Nadi; Abedi, Ghassem

    2017-03-01

    Recently, focusing on higher education quality has got increasingly critical. The novel managerial attitudes have defined the customer-demanded quality. Based on this, recognizing the receivers' perception of the quality of the services offered and evaluating the quality of the service is considered of the basic measures taken in order to develop quality promotion programs. Therefore, this is a qualitative research conducted for students' viewpoint on quality of educational services. This qualitative study has been performed by the phenomenological method. The samples have been selected based on goal-oriented approach. In this qualitative research, the required data have been collected in two phases (90 individual interviews and 30 focus group discussions) at Mazandaran University of Medical Sciences during which the participants have conveyed their experiences and expectations encountering the educational quality topic. All the interviews have been recorded and implemented. The interviews analysis has been carried out simultaneously with the implementation and using theme analysis by Smith method. According to the findings regarding the definition of quality, the students have emphasized two important aspects including "educational services standards by the teacher "and "the students' satisfaction". Thus the final education quality resulted from the students' experiences and perception is this way: "Presenting the students educational services in class and out of class compatible with the educational services standards so that it results in the students' satisfaction". When a person views her/him-self rightful as a customer, whatever seems necessary to them appears like a requirement. Then regarding paying attention and reflecting on the customers' perceived needs, it is possible to determine their expectations limit to some extent. Therefore, designing educational quality standards in order to evaluate the teachers' function without taking the stakeholders' perspective into account is not practical. This research-extracted finding can present the stakeholders' perspective encountering the educational quality.

  15. The Students’ Viewpoint on Quality of Educational Services in Iran

    PubMed Central

    Siamian, Hasan; Rostami, Farideh; Ghara, Aliasghar Nadi; Abedi, Ghassem

    2017-01-01

    Background: Recently, focusing on higher education quality has got increasingly critical. The novel managerial attitudes have defined the customer-demanded quality. Based on this, recognizing the receivers’ perception of the quality of the services offered and evaluating the quality of the service is considered of the basic measures taken in order to develop quality promotion programs. Therefore, this is a qualitative research conducted for students’ viewpoint on quality of educational services. Material and Methods: This qualitative study has been performed by the phenomenological method. The samples have been selected based on goal-oriented approach. In this qualitative research, the required data have been collected in two phases (90 individual interviews and 30 focus group discussions) at Mazandaran University of Medical Sciences during which the participants have conveyed their experiences and expectations encountering the educational quality topic. All the interviews have been recorded and implemented. The interviews analysis has been carried out simultaneously with the implementation and using theme analysis by Smith method. Results: According to the findings regarding the definition of quality, the students have emphasized two important aspects including “educational services standards by the teacher “and “the students’ satisfaction”. Thus the final education quality resulted from the students’ experiences and perception is this way: “Presenting the students educational services in class and out of class compatible with the educational services standards so that it results in the students’ satisfaction”. When a person views her/him-self rightful as a customer, whatever seems necessary to them appears like a requirement. Then regarding paying attention and reflecting on the customers’ perceived needs, it is possible to determine their expectations limit to some extent. Conclusion: Therefore, designing educational quality standards in order to evaluate the teachers’ function without taking the stakeholders’ perspective into account is not practical. This research-extracted finding can present the stakeholders’ perspective encountering the educational quality. PMID:28484355

  16. The quest for quality blood banking program in the new millennium the American way.

    PubMed

    Kim, Dae Un

    2002-08-01

    For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in implementing practices that assure quality and compliance with cGMP. AABB and CAP are granted "deemed status" as accrediting organizations under the CLIA '88 program by CMS, as well as JCAHO and some states. The International Standards Organization (ISO) has established international standards in most fields. The U.S. is represented in ISO by the American National Standards Institute (ANSI), and the National Committee for Clinical Laboratory Standards (NCCLS), as a global organization headquartered in the U.S., is a member of ANSI. The FDA and the AABB had begun incorporating many ISO principles into their own regulations and standards. The AABB's 10 QSEs are rooted in the 20 clauses of ISO 9000 series and compatible with their standards. In a Maslow-type model quality hierarchy by Tsiakals, so far the bottom three of the five progressive levels, Quality Control for method control, Quality Assurance for process control, and Quality System for system control have been implemented just to meet the regulatory and accrediting requirements. The next higher level, Quality Management for financial control, and the ultimate highest level, Total Quality Management for strategic control, should be our quest in this new millennium, and with the help of the AABB, ISO, FDA and all other organizations, we will achieve it. We should change our approach to quality issues from detection to prevention. We should improve the quality in transfusion practice itself by effective utilization of blood as a therapeutic resource with clear indication, maximum surgical blood order schedule, alternative transfusion such as autologous transfusion, hemodilution, and intra/post-operative blood salvage, surgical hemostasis, pharmacological hemostasis, and synthetic erythropoietin. Most importantly, implementation of the Quality Program should be something that we want to do rather than simply a burden that we have to do. A well-managed Quality Program is an effective and cost-efficient operation for the blood banks and transfusion services, and will enable us to better serve the patients for whom we exist.

  17. Quality factors in interventional neuroradiology.

    PubMed

    Lasjaunias, P

    2001-01-01

    The interest we take in medical economics and strategy is like the one we take in politics: we may scorn politics, but it cannot be denied that it commands our entire life. For this reason, we must try to determine the conditions required to evaluate the quality of interventional neuroradiology, its operators, its practice, its advances, its teaching, and to maintain this quality. It is probably vital to the freedom of our future therapeutic decisions that we contribute effectively to this discussion before the standard is forced upon us by an exclusively economical or administrative logic. On the other hand, any advance can only be turned into progress if it is diffused and applied. There is no doubt that several levels of quality are acceptable, thus the best approach will be to look for and identify the minimum standard for quality or the limits of non-quality. We shall refrain from suggesting that the level of excellence at a given moment should be imposed upon all operators and constitute the standard level of practice. Practice is based on knowledge and competence. The most skilled surgical act cannot guarantee safe medical treatment if it is not supported by sufficient knowledge about the diseases and their symptoms. Mastership of the decision process requires a thorough vision of the therapeutic decision tree involved. Quality is a composition of global view and detailed analysis to allow a fuzzy gestion of the performance. Regardless of the plan chosen, openmindedness should be kept to allow adaptation, correction or interruption of a given therapeutic process in view of unpredicted pieces of information. Such input is a predictable possibility that should be explained to the patient prior to starting the procedure. Dealing with human beings, the attitude along with the technical management will be of paramount importance in the overall quality assessment.

  18. Hearing Aid–Related Standards and Test Systems

    PubMed Central

    Ravn, Gert; Preves, David

    2015-01-01

    Many documents describe standardized methods and standard equipment requirements in the field of audiology and hearing aids. These standards will ensure a uniform level and a high quality of both the methods and equipment used in audiological work. The standards create the basis for measuring performance in a reproducible manner and independent from how and when and by whom parameters have been measured. This article explains, and focuses on, relevant acoustic and electromagnetic compatibility parameters and describes several test systems available. PMID:27516709

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

    PubMed

    Rout, John; Brown, Jackie

    2012-06-01

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

  20. Photogrammetry and Remote Sensing: New German Standards (din) Setting Quality Requirements of Products Generated by Digital Cameras, Pan-Sharpening and Classification

    NASA Astrophysics Data System (ADS)

    Reulke, R.; Baltrusch, S.; Brunn, A.; Komp, K.; Kresse, W.; von Schönermark, M.; Spreckels, V.

    2012-08-01

    10 years after the first introduction of a digital airborne mapping camera in the ISPRS conference 2000 in Amsterdam, several digital cameras are now available. They are well established in the market and have replaced the analogue camera. A general improvement in image quality accompanied the digital camera development. The signal-to-noise ratio and the dynamic range are significantly better than with the analogue cameras. In addition, digital cameras can be spectrally and radiometrically calibrated. The use of these cameras required a rethinking in many places though. New data products were introduced. In the recent years, some activities took place that should lead to a better understanding of the cameras and the data produced by these cameras. Several projects, like the projects of the German Society for Photogrammetry, Remote Sensing and Geoinformation (DGPF) or EuroSDR (European Spatial Data Research), were conducted to test and compare the performance of the different cameras. In this paper the current DIN (Deutsches Institut fuer Normung - German Institute for Standardization) standards will be presented. These include the standard for digital cameras, the standard for ortho rectification, the standard for classification, and the standard for pan-sharpening. In addition, standards for the derivation of elevation models, the use of Radar / SAR, and image quality are in preparation. The OGC has indicated its interest in participating that development. The OGC has already published specifications in the field of photogrammetry and remote sensing. One goal of joint future work could be to merge these formerly independent developments and the joint development of a suite of implementation specifications for photogrammetry and remote sensing.

  1. Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study

    PubMed Central

    Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

    2016-01-01

    Background The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)–enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user’s experience. Objective The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. Methods This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods (“protocols”) of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. Results A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. Conclusions In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. PMID:27793791

  2. Natural Language Processing-Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study.

    PubMed

    Kaufman, David R; Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

    2016-10-28

    The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)-enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user's experience. The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods ("protocols") of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. ©David R. Kaufman, Barbara Sheehan, Peter Stetson, Ashish R. Bhatt, Adele I. Field, Chirag Patel, James Mark Maisel. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 28.10.2016.

  3. 75 FR 232 - Finding of Failure To Submit Certain State Implementation Plans Required for the 1-Hour Ozone NAAQS

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... Failure To Submit Certain State Implementation Plans Required for the 1-Hour Ozone NAAQS AGENCY...) for three ozone nonattainment areas to satisfy certain requirements of the Clean Air Act (CAA) for the 1-hour ozone National Ambient Air Quality Standards (NAAQS). To accompany this action we are issuing...

  4. 40 CFR 51.1011 - Requirements for mid-course review.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Requirements for mid-course review. 51... PM2.5 National Ambient Air Quality Standards § 51.1011 Requirements for mid-course review. (a) Any... attainment date of nine or ten years from the date of designation also must submit to EPA a mid-course review...

  5. 40 CFR 51.1011 - Requirements for mid-course review.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Requirements for mid-course review. 51... PM2.5 National Ambient Air Quality Standards § 51.1011 Requirements for mid-course review. (a) Any... attainment date of nine or ten years from the date of designation also must submit to EPA a mid-course review...

  6. General Conformity

    EPA Pesticide Factsheets

    The General Conformity requirements ensure that the actions taken by federal agencies in nonattainment and maintenance areas do not interfere with a state’s plans to meet national standards for air quality.

  7. 9 CFR 113.50 - Ingredients of biological products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently...

  8. Software for improving the quality of project management, a case study: international manufacture of electrical equipment

    NASA Astrophysics Data System (ADS)

    Preradović, D. M.; Mićić, Lj S.; Barz, C.

    2017-05-01

    Production conditions in today’s world require software support at every stage of production and development of new products, for quality assurance and compliance with ISO standards. In addition to ISO standards such as usual metrics of quality, companies today are focused on other optional standards, such as CMMI (Capability Maturity Model Integrated) or prescribing they own standards. However, while there is intensive progress being made in the PM (project management), there is still a significant number of projects, at the global level, that are failures. These have failed to achieve their goals, within budget or timeframe. This paper focuses on checking the role of software tools through the rate of success in projects implemented in the case of internationally manufactured electrical equipment. The results of this research show the level of contribution of the project management software used to manage and develop new products to improve PM processes and PM functions, and how selection of the software tools affects the quality of PM processes and successfully completed projects.

  9. Are the defined substrate-based methods adequate to determine the microbiological quality of natural recreational waters?

    PubMed

    Valente, Marta Sofia; Pedro, Paulo; Alonso, M Carmen; Borrego, Juan J; Dionísio, Lídia

    2010-03-01

    Monitoring the microbiological quality of water used for recreational activities is very important to human public health. Although the sanitary quality of recreational marine waters could be evaluated by standard methods, they are time-consuming and need confirmation. For these reasons, faster and more sensitive methods, such as the defined substrate-based technology, have been developed. In the present work, we have compared the standard method of membrane filtration using Tergitol-TTC agar for total coliforms and Escherichia coli, and Slanetz and Bartley agar for enterococci, and the IDEXX defined substrate technology for these faecal pollution indicators to determine the microbiological quality of natural recreational waters. ISO 17994:2004 standard was used to compare these methods. The IDEXX for total coliforms and E. coli, Colilert, showed higher values than those obtained by the standard method. Enterolert test, for the enumeration of enterococci, showed lower values when compared with the standard method. It may be concluded that more studies to evaluate the precision and accuracy of the rapid tests are required in order to apply them for routine monitoring of marine and freshwater recreational bathing areas. The main advantages of these methods are that they are more specific, feasible and simpler than the standard methodology.

  10. Data collection automation and total quality management: case studies in the health-service industry.

    PubMed

    Smith, Alan D; Offodile, O Felix

    2008-01-01

    The limitations, immeasurable, and seemly unquantifiable aspects of the healthcare service industry, make it imperative that quality assurance programs include total quality management (TQM) and automatic identification and data capture (AIDC)-related technologies. Most of standards used in TQM and AIDC require data, to measure improvement and achieve standardization. Major difference between managing a service firm and managing a product-manufacturing firm is the difficulty of achieving consistently high quality. Examination of two different healthcare service providers in the Pittsburgh, Pennsylvania area offers different views as to the implementation and practice of total quality management techniques and AIDC integration. Since the healthcare service industry must take into account its high customization needs, there are positive steps to make the hospital structure itself more patient friendly and quality related; hence improving its heath-marketing strategies to the general public.

  11. Quality Control Review of Coopers & Lybrand L.L.P. Polytechnic University. Fiscal Year Ended June 30, 1996

    DTIC Science & Technology

    1998-05-18

    The objective of a quality control review is to assure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-I 33. As the cognizant Federal agency for the University, we conducted a quality control review of the audit working...papers. We focused our review on the following qualitative aspects of the audit : due professional care, planning, supervision, independence, quality

  12. Integrating sentinel watershed-systems into the monitoring and assessment of Minnesota's (USA) waters quality.

    PubMed

    Magner, J A; Brooks, K N

    2008-03-01

    Section 303(d) of the Clean Water Act requires States and Tribes to list waters not meeting water quality standards. A total maximum daily load must be prepared for waters identified as impaired with respect to water quality standards. Historically, the management of pollution in Minnesota has been focused on point-source regulation. Regulatory effort in Minnesota has improved water quality over the last three decades. Non-point source pollution has become the largest driver of conventional 303(d) listings in the 21st century. Conventional pollutants, i.e., organic, sediment and nutrient imbalances can be identified with poor land use management practices. However, the cause and effect relationship can be elusive because of natural watershed-system influences that vary with scale. Elucidation is complex because the current water quality standards in Minnesota were designed to work best with water quality permits to control point sources of pollution. This paper presents a sentinel watershed-systems approach (SWSA) to the monitoring and assessment of Minnesota waterbodies. SWSA integrates physical, chemical, and biological data over space and time using advanced technologies at selected small watersheds across Minnesota to potentially improve understanding of natural and anthropogenic watershed processes and the management of point and non-point sources of pollution. Long-term, state-of-the-art monitoring and assessment is needed to advance and improve water quality standards. Advanced water quality or ecologically-based standards that integrate physical, chemical, and biological numeric criteria offer the potential to better understand, manage, protect, and restore Minnesota's waterbodies.

  13. Transforming an EPA QA/R-2 quality management plan into an ISO 9002 quality management system.

    PubMed

    Kell, R A; Hedin, C M; Kassakhian, G H; Reynolds, E S

    2001-01-01

    The Environmental Protection Agency's (EPA) Office of Emergency and Remedial Response (OERR) requires environmental data of known quality to support Superfund hazardous waste site projects. The Quality Assurance Technical Support (QATS) Program is operated by Shaw Environmental and Infrastructure, Inc. to provide EPA's Analytical Operations Center (AOC) with performance evaluation samples, reference materials, on-site laboratory auditing capabilities, data audits (including electronic media data audits), methods development, and other support services. The new QATS contract awarded in November 2000 required that the QATS Program become ISO 9000 certified. In a first for an EPA contractor, the QATS staff and management successfully transformed EPA's QA/R-2 type Quality Management Plan into a Quality Management System (QMS) that complies with the requirements of the internationally recognized ISO 9002 standard and achieved certification in the United States, Canada, and throughout Europe. The presentation describes how quality system elements of ISO 9002 were implemented on an already existing quality system. The psychological and organizational challenges of the culture change in QATS' day-to-day operations will be discussed for the benefit of other ISO 9000 aspirants.

  14. External quality assessment programs in the context of ISO 15189 accreditation.

    PubMed

    Sciacovelli, Laura; Secchiero, Sandra; Padoan, Andrea; Plebani, Mario

    2018-05-23

    Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

  15. Marketing and Distribution: Michigan Program Standards Mean Improved Quality in DE

    ERIC Educational Resources Information Center

    Daenzer, John A.

    1977-01-01

    Various program activities are described which the State of Michigan requires its local education agencies to be involved in as the basis for making program adjustments that would improve program quality, e.g., occupational advisory committees, placement services, followup studies, performance based education, and annual and long-range planning.…

  16. Factors Affecting Success of Training Companies

    ERIC Educational Resources Information Center

    Rogala, Piotr; Batko, Roman; Wawak, Slawomir

    2017-01-01

    This study aims to identify the key factors which influence the functioning quality and success of training companies. Based on an analysis of the requirements included in the quality management system standards for providers of education and training services, a set of twenty factors has been developed. This was followed by a survey for…

  17. 76 FR 63909 - Draft Programmatic Environmental Impact Statement (EIS) for Modernization of Training...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... the training requirements of military units in Hawai`i. This modernization would improve the quality... at PTA are old, are operating beyond their useful life and do not meet current DoD design standards... with the possible effects to air quality, historic resources, and threatened and endangered species...

  18. 45 CFR 98.51 - Activities to improve the quality of child care.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... applicable State, local, and tribal child care standards, including applicable health and safety requirements... 45 Public Welfare 1 2012-10-01 2012-10-01 false Activities to improve the quality of child care. 98.51 Section 98.51 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

  19. 45 CFR 98.51 - Activities to improve the quality of child care.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... applicable State, local, and tribal child care standards, including applicable health and safety requirements... 45 Public Welfare 1 2010-10-01 2010-10-01 false Activities to improve the quality of child care. 98.51 Section 98.51 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

  20. 45 CFR 98.51 - Activities to improve the quality of child care.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... applicable State, local, and tribal child care standards, including applicable health and safety requirements... 45 Public Welfare 1 2011-10-01 2011-10-01 false Activities to improve the quality of child care. 98.51 Section 98.51 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

  1. 45 CFR 98.51 - Activities to improve the quality of child care.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... applicable State, local, and tribal child care standards, including applicable health and safety requirements... 45 Public Welfare 1 2014-10-01 2014-10-01 false Activities to improve the quality of child care. 98.51 Section 98.51 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION...

  2. 45 CFR 98.51 - Activities to improve the quality of child care.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... applicable State, local, and tribal child care standards, including applicable health and safety requirements... 45 Public Welfare 1 2013-10-01 2013-10-01 false Activities to improve the quality of child care. 98.51 Section 98.51 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

  3. Quality Assurance for Digital Learning Object Repositories: Issues for the Metadata Creation Process

    ERIC Educational Resources Information Center

    Currier, Sarah; Barton, Jane; O'Beirne, Ronan; Ryan, Ben

    2004-01-01

    Metadata enables users to find the resources they require, therefore it is an important component of any digital learning object repository. Much work has already been done within the learning technology community to assure metadata quality, focused on the development of metadata standards, specifications and vocabularies and their implementation…

  4. 42 CFR § 512.411 - Quality measures and reporting for AMI model.

    Code of Federal Regulations, 2010 CFR

    2017-10-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS EPISODE PAYMENT MODEL... 42 Public Health 5 2017-10-01 2017-10-01 false Quality measures and reporting for AMI model. Â... reporting for AMI model. (a) Required measures. (1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality...

  5. 42 CFR § 512.412 - Quality measures and reporting for CABG model.

    Code of Federal Regulations, 2010 CFR

    2017-10-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS EPISODE PAYMENT MODEL... 42 Public Health 5 2017-10-01 2017-10-01 false Quality measures and reporting for CABG model. Â... reporting for CABG model. (a) Required measures. (1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality...

  6. (PRESENTED IN ALBERTA, CANADA) A PERFORMANCE EVALUATION OF THE 2004 RELEASE OF MODELS-3 CMAQ

    EPA Science Inventory

    The Clean Air Act and its Amendments require that the U.S. Environmental Protection Agency (EPA) establish National Ambient Air Quality Standards for O3 and particulate matter and to assess current and future air quality regulations designed to protect human health and...

  7. Implementing Total Quality Management in Vocational Education.

    ERIC Educational Resources Information Center

    Navaratnam, K. K.; Mountney, Peter

    In an internationally competitive training environment, implementation of Total Quality Management (TQM) in vocational education can provide a comparative advantage in preparing the type of work force required for micro and macro economic reforms. The concept of TQM can be used as a management tool to improve the standards of vocational training.…

  8. Alternative Strategies for Control of Sulfur Dioxide Emissions

    ERIC Educational Resources Information Center

    MacDonald, Bryce I.

    1975-01-01

    Achievement of air quality goals requires careful consideration of alternative control strategies in view of national concerns with energy and the economy. Three strategies which might be used by coal fired steam electric plants to achieve ambient air quality standards for sulfur dioxide have been compared and the analysis presented. (Author/BT)

  9. Implementation of Quality Systems in Nuclear Medicine: Why It Matters. An Outcome Analysis (Quality Management Audits in Nuclear Medicine Part III).

    PubMed

    Dondi, Maurizio; Paez, Diana; Torres, Leonel; Marengo, Mario; Delaloye, Angelika Bischof; Solanki, Kishor; Van Zyl Ellmann, Annare; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Giammarile, Francesco; Pascual, Thomas

    2018-05-01

    The International Atomic Energy Agency (IAEA) developed a comprehensive program-Quality Management Audits in Nuclear Medicine (QUANUM). This program covers all aspects of nuclear medicine practices including, but not limited to, clinical practice, management, operations, and services. The QUANUM program, which includes quality standards detailed in relevant checklists, aims at introducing a culture of comprehensive quality audit processes that are patient oriented, systematic, and outcome based. This paper will focus on the impact of the implementation of QUANUM on daily routine practices in audited centers. Thirty-seven centers, which had been externally audited by experts under IAEA auspices at least 1 year earlier, were invited to run an internal audit using the QUANUM checklists. The external audits also served as training in quality management and the use of QUANUM for the local teams, which were responsible of conducting the internal audits. Twenty-five out of the 37 centers provided their internal audit report, which was compared with the previous external audit. The program requires that auditors score each requirement within the QUANUM checklists on a scale of 0-4, where 0-2 means nonconformance and 3-4 means conformance to international regulations and standards on which QUANUM is based. Our analysis covering both general and clinical areas assessed changes on the conformance status on a binary manner and the level of conformance scores. Statistical analysis was performed using nonparametric statistical tests. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P < 0.01). The evaluation of the requirements by checklist also showed a significant improvement in all, with the exception of Hormones and Tumor marker determinations, where changes were not significant. Of the 25 evaluated institutions, 88% (22 of 25) and 92% (23 of 25) improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. In 8 key areas, the number of improved requirements was well above the average: Administration & Management (checklist 2); Radiation Protection & Safety (checklist 4); General Quality Assurance system (checklist 6); Imaging Equipment Quality Assurance or Quality Control (checklist 7); General Diagnostic (checklist 9); General Therapeutic (checklist 12); Radiopharmacy Level 1 (checklist 14); and Radiopharmacy Level 2 (checklist 15). Analysis of results related to clinical activities showed an overall positive impact on both the status and the level of conformance to international standards. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures. Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program has a positive impact on nuclear medicine practices. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  10. 77 FR 71371 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Redesignation of the Ohio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ....5 , NO X and sulfur dioxide (SO 2 ) emissions inventories as satisfying the requirement in section... control measures include the following. Tier 2 Emission Standards for Vehicles and Gasoline Sulfur... vehicles replace older vehicles. The Tier 2 standards also reduced the sulfur content of gasoline to 30...

  11. 76 FR 73777 - Guidance on Due Diligence Requirements in Determining Whether Investment Securities Are Eligible...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... quality will meet this standard. National banks will have to meet this new standard before purchasing... at 12 U.S.C. 1831e(d)(1), which currently limits savings associations to purchasing corporate debt... explaining the due diligence national banks and Federal savings associations should conduct in purchasing...

  12. 78 FR 8448 - Streamlining Inspection and Warranty Requirements for Federal Housing Administration (FHA) Single...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... jurisdiction did not already perform its own inspections for new construction, and issue building permits and... expected to be minimal. The increased quality of construction materials and the standardization of building... governments that have adopted building codes to regulate and standardize the construction of residential and...

  13. 78 FR 48103 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Redesignation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... Redesignation Request ii. Subpart 4 Requirements and Illinois' Redesignation Request iii. Subpart 4 and Control... due to permanent and enforceable emission reductions? 1. Permanent and Enforceable Controls a. Federal Emission Control Measures i. Tier 2 Emission Standards for Vehicles and Gasoline Sulfur Standards ii. Heavy...

  14. The National Map seamless digital elevation model specifications

    USGS Publications Warehouse

    Archuleta, Christy-Ann M.; Constance, Eric W.; Arundel, Samantha T.; Lowe, Amanda J.; Mantey, Kimberly S.; Phillips, Lori A.

    2017-08-02

    This specification documents the requirements and standards used to produce the seamless elevation layers for The National Map of the United States. Seamless elevation data are available for the conterminous United States, Hawaii, Alaska, and the U.S. territories, in three different resolutions—1/3-arc-second, 1-arc-second, and 2-arc-second. These specifications include requirements and standards information about source data requirements, spatial reference system, distribution tiling schemes, horizontal resolution, vertical accuracy, digital elevation model surface treatment, georeferencing, data source and tile dates, distribution and supporting file formats, void areas, metadata, spatial metadata, and quality assurance and control.

  15. Requirements for conformal coating and staking of printed wiring boards and electronic assemblies

    NASA Technical Reports Server (NTRS)

    1985-01-01

    In order to maintain the high standards of the NASA conformal coating and staking program, this publication: prescribes NASA's requirements for assuring reliable conformal coating and staking for printed wiring boards and electronic assemblies; describes and incorporates basic considerations necessary to assure reliable conformal coating and staking; 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.

  16. Water quality program elements for Space Station Freedom

    NASA Technical Reports Server (NTRS)

    Sauer, Richard L.; Ramanathan, Raghupathy; Straub, John E.; Schultz, John R.

    1991-01-01

    A strategy is outlined for the development of water-quality criteria and standards relevant to recycling and monitoring the in-flight water for the Space Station Freedom (SSF). The water-reclamation subsystem of the SSF's ECLSS is described, and the objectives of the water-quality are set forth with attention to contaminants. Quality parameters are listed for potable and hygiene-related water including physical and organic parameters, inorganic constituents, bactericides, and microbial content. Comparisons are made to the quality parameters established for the Shuttle's potable water and to the EPA's current standards. Specific research is required to develop in-flight monitoring techniques for unique SSF contaminants, ECLSS microbial control, and on- and off-line monitoring. After discussing some of the in-flight water-monitoring hardware it is concluded that water reclamation and recycling are necessary and feasible for the SSF.

  17. Medical education today: globalising with quality.

    PubMed

    Shahabudin, S H

    2005-08-01

    With globalization education has become a tradable service governed by the rules and regulations of GATS and worth trillions of dollars. International standards are rapidly being developed to facilitate cross border supply of services. In medical education, the WFME has produced International Guidelines on Quality in Medical Education which has a regional equivalent in the WHO Western Pacific Region, and the IIME has defined the minimum essential requirements of standards in medical education in seven core competences. Malaysia, having an explicit policy of making education a sector for revenue generation, has put in place regulatory frameworks and incentives to make the country a centre of educational excellence. Within the ambit of this national aspiration, medical education has grown phenomenally in the last decade. Standards and procedures for accreditation of medical schools in line with the world standards have been developed and implemented and policies are enforced to facilitate compliance to the standards. The ultimate goal is for medical schools to be self-accredited. In striving towards self-accreditation medical schools should be innovative in making changes in the three requirements of medical education. These are the intellectual and social imperatives and strategies for effective implementation.

  18. Theoretical considerations and measurements for phoropters

    NASA Astrophysics Data System (ADS)

    Zhang, Jiyan; Liu, Wenli; Sun, Jie

    2008-10-01

    A phoropter is one of the most popular ophthalmic instruments used in current optometry practice. The quality and verification of the instrument are of the utmost importance. In 1997, International Organization for Standardization published the first ISO standard for requirements of phoropters. However, in China, few standard and test method are suggested for phoropters. Research work on test method for phoropters was carried out early in 2004 by China National Institute of Metrology. In this paper, first, structure of phoropters is described. Then, theoretical considerations for its optical design are analyzed. Next, a newly developed instrument is introduced and measurements are taken. By calibration, the indication error of the instrument is not over 0.05m-1. Finally, measurement results show that the quality situation of phoropters is not as good as expected because of production and assembly error. Optical design shall be improved especially for combinations of both spherical and cylindrical lenses with higher power. Besides, optical requirements specified in ISO standard are found to be a little strict and hard to meet. A proposal for revision of this international standard is drafted and discussed on ISO meeting of 2007 held in Tokyo.

  19. Evaluation of thermal cameras in quality systems according to ISO 9000 or EN 45000 standards

    NASA Astrophysics Data System (ADS)

    Chrzanowski, Krzysztof

    2001-03-01

    According to the international standards ISO 9001-9004 and EN 45001-45003 the industrial plants and the accreditation laboratories that implemented the quality systems according to these standards are required to evaluate an uncertainty of measurements. Manufacturers of thermal cameras do not offer any data that could enable estimation of measurement uncertainty of these imagers. Difficulties in determining the measurement uncertainty is an important limitation of thermal cameras for applications in the industrial plants and the cooperating accreditation laboratories that have implemented these quality systems. A set of parameters for characterization of commercial thermal cameras, a measuring set, some results of testing of these cameras, a mathematical model of uncertainty, and a software that enables quick calculation of uncertainty of temperature measurements with thermal cameras are presented in this paper.

  20. Saving Material with Systematic Process Designs

    NASA Astrophysics Data System (ADS)

    Kerausch, M.

    2011-08-01

    Global competition is forcing the stamping industry to further increase quality, to shorten time-to-market and to reduce total cost. Continuous balancing between these classical time-cost-quality targets throughout the product development cycle is required to ensure future economical success. In today's industrial practice, die layout standards are typically assumed to implicitly ensure the balancing of company specific time-cost-quality targets. Although die layout standards are a very successful approach, there are two methodical disadvantages. First, the capabilities for tool design have to be continuously adapted to technological innovations; e.g. to take advantage of the full forming capability of new materials. Secondly, the great variety of die design aspects have to be reduced to a generic rule or guideline; e.g. binder shape, draw-in conditions or the use of drawbeads. Therefore, it is important to not overlook cost or quality opportunities when applying die design standards. This paper describes a systematic workflow with focus on minimizing material consumption. The starting point of the investigation is a full process plan for a typical structural part. All requirements are definedaccording to a predefined set of die design standards with industrial relevance are fulfilled. In a first step binder and addendum geometry is systematically checked for material saving potentials. In a second step, blank shape and draw-in are adjusted to meet thinning, wrinkling and springback targets for a minimum blank solution. Finally the identified die layout is validated with respect to production robustness versus splits, wrinkles and springback. For all three steps the applied methodology is based on finite element simulation combined with a stochastical variation of input variables. With the proposed workflow a well-balanced (time-cost-quality) production process assuring minimal material consumption can be achieved.

  1. KSC Center Director Bridges addresses the audience at an ISO 9001 certification ceremony

    NASA Technical Reports Server (NTRS)

    1998-01-01

    Center Director Roy Bridges speaks to KSC employees at the ISO certification ceremony held at the Training Auditorium. Bridges was presented an ISO 9001 certificate and plaque awarded to KSC by Det Norske Veritas (DNV), Inc., an international ISO certification organization. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world- class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification. Next to Bridges is Heidi Hollingsworth, with the Center for Independent Living, who uses American Sign Language for any hearing-impaired employees in the audience.

  2. Asthma Outcomes: Quality of Life

    PubMed Central

    Wilson, Sandra R.; Rand, Cynthia S.; Cabana, Michael D.; Foggs, Michael B.; Halterman, Jill S.; Olson, Lynn; Vollmer, William M.; Wright, Rosalind J.; Taggart, Virginia

    2014-01-01

    Background “Asthma-related quality of life” refers to the perceived impact that asthma has on the patient’s quality of life. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to recommend standardized measures of the impact of asthma on quality of life for use in future asthma clinical research. Methods We reviewed published documentation regarding the development and psychometric evaluation; clinical research use since 2000; and extent to which the content of each existing quality of life instrument provides a unique, reliable, and valid assessment of the intended construct. We classified instruments as core (required in future studies), supplemental (used according to the study’s aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop convened in March 2010 and finalized in September 2011. Results Eleven instruments for adults and 6 for children were identified for review. None qualified as core instruments because they predominantly measured indicators of asthma control (symptoms and/or functional status); failed to provide a distinct, reliable score measuring all key dimensions of the intended construct; and/or lacked adequate psychometric data. Conclusions In the absence of existing instruments that meet the stated criteria, currently available instruments are classified as either supplemental or emerging. Research is strongly recommended to develop and evaluate instruments that provide a distinct, reliable measure of the patient’s perception of the impact of asthma on all of the key dimensions of quality of life, an important outcome that is not captured in other outcome measures. PMID:22386511

  3. 36 CFR 228.8 - Requirements for environmental protection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... State water quality standards, including regulations issued pursuant to the Federal Water Pollution... to minimize or, where practicable, eliminate damage to soil, water, and other resource values. Unless...

  4. 24 CFR 582.305 - Housing quality standards; rent reasonableness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Development (Continued) OFFICE OF ASSISTANT SECRETARY FOR COMMUNITY PLANNING AND DEVELOPMENT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT COMMUNITY FACILITIES SHELTER PLUS CARE Program Requirements § 582.305...

  5. How to Select a Questionnaire with a Good Methodological Quality?

    PubMed

    Paiva, Saul Martins; Perazzo, Matheus de França; Ortiz, Fernanda Ruffo; Pordeus, Isabela Almeida; Martins-Júnior, Paulo Antônio

    2018-01-01

    In the last decades, several instruments have been used to evaluate the impact of oral health problems on the oral health-related quality of life (OHRQoL) of individuals. However, some instruments lack thorough methodological validation or present conceptual differences that hinder comparisons with instruments. Thus, it can be difficult to clinicians and researchers to select a questionnaire that accurately reflect what are really meaningful to individuals. This short communication aimed to discuss the importance of use an appropriate checklist to select an instrument with a good methodological quality. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to provide tools for evidence-based instrument selection. The COSMIN checklist comprises ten boxes that evaluate whether a study meets the standard for good methodological quality and two additional boxes to meet studies that use the Item Response Theory method and general requirements for results generalization, resulting in four steps to be followed. In this way, it is required at least some expertise in psychometrics or clinimetrics to a wide-ranging use of this checklist. The COSMIN applications include its use to ensure the standardization of cross-cultural adaptations and safer comparisons between measurement studies and evaluation of methodological quality of systematic reviews of measurement properties. Also, it can be used by students when training about measurement properties and by editors and reviewers when revising manuscripts on this topic. The popularization of COSMIN checklist is therefore necessary to improve the selection and evaluation of health measurement instruments.

  6. Roles of laboratories and laboratory systems in effective tuberculosis programmes.

    PubMed

    Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul

    2007-05-01

    Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.

  7. Tool simplifies machining of pipe ends for precision welding

    NASA Technical Reports Server (NTRS)

    Matus, S. T.

    1969-01-01

    Single tool prepares a pipe end for precision welding by simultaneously performing internal machining, end facing, and bevel cutting to specification standards. The machining operation requires only one milling adjustment, can be performed quickly, and produces the high quality pipe-end configurations required to ensure precision-welded joints.

  8. 75 FR 72964 - Disapproval and Promulgation of Air Quality Implementation Plans; Indiana; Addition of Incentive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... limits, and the processing of pollution prevention projects as minor permit revisions. EPA proposed to... standard. EPA is disapproving the third incentive, which affects public notice requirements for pollution prevention projects, because it relaxes the existing SIP-approved public notice requirements and is...

  9. 40 CFR 63.1 - Applicability.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of Air Quality Planning and Standards, U.S. EPA (MD-13), Research Triangle Park, North Carolina 27711... or before the number of days specified in the applicable requirement. For example, if a notification... part, the owner or operator of an affected source may be required to obtain a title V permit from a...

  10. 78 FR 20793 - Approval and Promulgation of Implementation Plans; Mississippi; 110(a)(2)(E)(ii) Infrastructure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... and 2006 Fine Particulate Matter National Ambient Air Quality Standards AGENCY: Environmental...) requirements for the 1997 annual and 2006 24-hour fine particulate matter (PM 2.5 ) National Ambient Air..., Incorporation by reference, Nitrogen dioxide, Particulate Matter, Reporting and recordkeeping requirements...

  11. Standardized quality-assessment system to evaluate pressure ulcer care in the nursing home.

    PubMed

    Bates-Jensen, Barbara M; Cadogan, Mary; Jorge, Jennifer; Schnelle, John F

    2003-09-01

    To demonstrate reliability and feasibility of a standardized protocol to assess and score quality indicators relevant to pressure ulcer (PU) care processes in nursing homes (NHs). Descriptive. Eight NHs. One hundred ninety-one NH residents for whom the PU Resident Assessment Protocol of the Minimum Data Set was initiated. Nine quality indicators (two related to screening and prevention of PU, two focused on assessment, and five addressing management) were scored using medical record data, direct human observation, and wireless thigh monitor observation data. Feasibility and reliability of medical record, observation, and thigh monitor protocols were determined. The percentage of participants who passed each of the indicators, indicating care consistent with practice guidelines, ranged from 0% to 98% across all indicators. In general, participants in NHs passed fewer indicators and had more problems with medical record accuracy before a PU was detected (screening/prevention indicators) than they did once an ulcer was documented (assessment and management indicators). Reliability of the medical record protocol showed kappa statistics ranging from 0.689 to 1.00 and percentage agreement from 80% to 100%. Direct observation protocols yielded kappa statistics of 0.979 and 0.928. Thigh monitor protocols showed kappa statistics ranging from 0.609 to 0.842. Training was variable, with the observation protocol requiring 1 to 2 hours, medical records requiring joint review of 20 charts with average time to complete the review of 20 minutes, and the thigh monitor data requiring 1 week for training in data preparation and interpretation. The standardized quality assessment system generated scores for nine PU quality indicators with good reliability and provided explicit scoring rules that permit reproducible conclusions about PU care. The focus of the indicators on care processes that are under the control of NH staff made the protocol useful for external survey and internal quality improvement purposes, and the thigh monitor observational technology provided a method for monitoring repositioning care processes that were otherwise difficult to monitor and manage.

  12. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    PubMed

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

  13. Global challenges of graduate level Ayurvedic education: A survey

    PubMed Central

    Patwardhan, Kishor; Gehlot, Sangeeta; Singh, Girish; Rathore, H.C.S.

    2010-01-01

    In the present day scenario, Ayurveda is globally being perceived in several contradictory ways. Poor quality of Ayurveda graduates produced as a result of poorly structured and poorly regulated education system is at least one of the important factors responsible for this scenario. The present study was carried out to evaluate the ‘Global challenges of graduate level Ayurvedic education’ and is based on the responses of Ayurvedic students and Ayurvedic teachers from various educational institutions of India to a methodically validated questionnaire. As the study indicates, the poor standard of Ayurvedic education in India is definitely a cause of concern. The curriculum of Bachelor of Ayurvedic Medicine and Surgery (BAMS) course of studies is required to be reviewed and restructured. The syllabi are required to be updated with certain relevant topics like laws governing the intellectual property rights, basic procedures of standardization of medicinal products, fundamental methods of evaluating the toxicity of the medicinal products, essentials of healthcare management and the basics of cultivation and marketing of medicinal plants. Furthermore, the study suggests that the Ayurvedic academicians are required to be trained in standard methods of research and documentation skills, and the educational institutions are required to be encouraged to contribute their share in building up the evidence base for Ayurveda in the form of quality education and research. PMID:20532099

  14. Quality Control Practices for Chemistry and Immunochemistry in a Cohort of 21 Large Academic Medical Centers.

    PubMed

    Rosenbaum, Matthew W; Flood, James G; Melanson, Stacy E F; Baumann, Nikola A; Marzinke, Mark A; Rai, Alex J; Hayden, Joshua; Wu, Alan H B; Ladror, Megan; Lifshitz, Mark S; Scott, Mitchell G; Peck-Palmer, Octavia M; Bowen, Raffick; Babic, Nikolina; Sobhani, Kimia; Giacherio, Donald; Bocsi, Gregary T; Herman, Daniel S; Wang, Ping; Toffaletti, John; Handel, Elizabeth; Kelly, Kathleen A; Albeiroti, Sami; Wang, Sihe; Zimmer, Melissa; Driver, Brandon; Yi, Xin; Wilburn, Clayton; Lewandrowski, Kent B

    2018-05-29

    In the United States, minimum standards for quality control (QC) are specified in federal law under the Clinical Laboratory Improvement Amendment and its revisions. Beyond meeting this required standard, laboratories have flexibility to determine their overall QC program. We surveyed chemistry and immunochemistry QC procedures at 21 clinical laboratories within leading academic medical centers to assess if standardized QC practices exist for chemistry and immunochemistry testing. We observed significant variation and unexpected similarities in practice across laboratories, including QC frequency, cutoffs, number of levels analyzed, and other features. This variation in practice indicates an opportunity exists to establish an evidence-based approach to QC that can be generalized across institutions.

  15. Ride quality and international standard ISO 2631 (Guide for the evaluation of human exposure to whole-body vibration)

    NASA Technical Reports Server (NTRS)

    Allen, G. R.

    1975-01-01

    The evolution of the standard, which is aimed at promoting research and production of more data, and providing some design guidance, is outlined and its contents summarized. Some of the assumptions and information on which it is based are analyzed. Its application to vehicle ride quality is considered in the context of the safety, efficiency and comfort of crew and passengers. The importance of establishing the precise criteria against which vibration limits are required is underlined, particularly the difficulties of first defining comfort and then postulating appropriate levels. Some current and future work related to improving the standard is outlined and additional suggestions offered.

  16. 40 CFR 51.916 - What are the requirements for an Ozone Transport Region under the 8-hour NAAQS?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false What are the requirements for an Ozone... IMPLEMENTATION PLANS Provisions for Implementation of 8-hour Ozone National Ambient Air Quality Standard § 51.916 What are the requirements for an Ozone Transport Region under the 8-hour NAAQS? (a) In General...

  17. 40 CFR 51.916 - What are the requirements for an Ozone Transport Region under the 8-hour NAAQS?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false What are the requirements for an Ozone... IMPLEMENTATION PLANS Provisions for Implementation of 8-hour Ozone National Ambient Air Quality Standard § 51.916 What are the requirements for an Ozone Transport Region under the 8-hour NAAQS? (a) In General...

  18. 40 CFR 51.916 - What are the requirements for an Ozone Transport Region under the 8-hour NAAQS?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false What are the requirements for an Ozone... IMPLEMENTATION PLANS Provisions for Implementation of 8-hour Ozone National Ambient Air Quality Standard § 51.916 What are the requirements for an Ozone Transport Region under the 8-hour NAAQS? (a) In General...

  19. 40 CFR 51.916 - What are the requirements for an Ozone Transport Region under the 8-hour NAAQS?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false What are the requirements for an Ozone... IMPLEMENTATION PLANS Provisions for Implementation of 8-hour Ozone National Ambient Air Quality Standard § 51.916 What are the requirements for an Ozone Transport Region under the 8-hour NAAQS? (a) In General...

  20. 40 CFR 51.916 - What are the requirements for an Ozone Transport Region under the 8-hour NAAQS?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false What are the requirements for an Ozone... IMPLEMENTATION PLANS Provisions for Implementation of 8-hour Ozone National Ambient Air Quality Standard § 51.916 What are the requirements for an Ozone Transport Region under the 8-hour NAAQS? (a) In General...

  1. Codex Alimentarius: food quality and safety standards for international trade.

    PubMed

    Randell, A W; Whitehead, A J

    1997-08-01

    Since 1962, the Codex Alimentarius Commission (CAC) of the Food and Agriculture Organisation/World Health Organisation has been responsible for developing standards, guidelines and other recommendations on the quality and safety of food to protect the health of consumers and to ensure fair practices in food trade. The mission of the CAC remains relevant, but a number of factors have shown the need for new techniques to form the basis of food standards, the most important of which is risk analysis. The authors give a brief description of the role and work of the CAC and the efforts deployed by the Commission to respond to the challenges posed by new approaches to government regulation, harmonisation of national requirements based on international standards and the role of civil society.

  2. Environmental health and safety issues related to the use of low-level radioactive waste (LLRW) at hospitals and medical research institutions and compliance determination with the Clean Air Act standards

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

    Kasinathan, R.; Kanchan, A.

    1995-12-31

    Currently, the United States Nuclear Regulatory Commission (NRC) has standards for procedures, performance activities and technical specifications on storage of Low-Level Radioactive Waste (LLRW) under 10 CFR Part 20. The United States Environmental Protection Agency (EPA) is proposing environmental standards for the management, storage and disposal of LLRW. The proposed standards, which will become 40 CFR part 193 when finalized, limits the committed effective dose to members of the public from the management and storage of LLRW, committed effective doses resulting from LLRW disposal and levels of radiological contamination of underground sources of drinking water as a result of themore » activities subject to management, storage and disposal of LLRW. Further, under Title III of the Clean Air Act Amendments, radionuclides are required to be inventoried for all generators. For hospitals and medical research institutions, quantities of LLRW are often below the concentrations required under reporting and record keeping requirements of 10 CFR 20. However, in many instances, the facility may require NRC permits and compliance with air quality dispersion modeling requirements. This paper presents the typical radionuclides used in hospitals and medical research institutions, and strategies to evaluate their usage and steps to achieve compliance. Air quality dispersion modeling by use of the COMPLY model is demonstrated to evaluate the fate of radionuclides released from on-site incineration of LLRW. The paper concludes that no significant threat is posed from the incineration of LLRW.« less

  3. Quality management in in vivo proton MRS.

    PubMed

    Pedrosa de Barros, Nuno; Slotboom, Johannes

    2017-07-15

    The quality of MR-Spectroscopy data can easily be affected in in vivo applications. Several factors may produce signal artefacts, and often these are not easily detected, not even by experienced spectroscopists. Reliable and reproducible in vivo MRS-data requires the definition of quality requirements and goals, implementation of measures to guarantee quality standards, regular control of data quality, and a continuous search for quality improvement. The first part of this review includes a general introduction to different aspects of quality management in MRS. It is followed by the description of a series of tests and phantoms that can be used to assure the quality of the MR system. In the third part, several methods and strategies used for quality control of the spectroscopy data are presented. This review concludes with a reference to a few interesting techniques and aspects that may help to further improve the quality of in vivo MR-spectra. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. [Air quality control systems: heating, ventilating, and air conditioning (HVAC)].

    PubMed

    Bellucci Sessa, R; Riccio, G

    2004-01-01

    After a brief illustration of the principal layout schemes of Heating, Ventilating, and Air Conditioning (HVAC), the first part of this paper summarizes the standards, both voluntary and compulsory, regulating HVAC facilities design and installation with regard to the question of Indoor Air Quality (IAQ). The paper then examines the problem of ventilation systems maintenance and the essential hygienistic requirements in whose absence HVAC facilities may become a risk factor for people working or living in the building. Lastly, the paper deals with HVAC design strategies and methods, which aim not only to satisfy comfort and air quality requirements, but also to ensure easy and effective maintenance procedures.

  5. Organizational leadership: A study on the affects of certification to International Organization for Standardization (ISO)

    NASA Astrophysics Data System (ADS)

    Cowart, Jewel S.

    Compliance to requirements of ISO is an important leadership problem for the International Aerospace Quality Group (IAQG) and the Aviation, Space and Defense (AS&D) companies. Furthermore, the IAQG seeks to understand the valuation of ISO/AS9100 requirements (2009), audit practices, management functions, business performance, customer satisfaction, and potential future concepts for the standard to assure quality. Since the release of the AS9100C total certification growth surpassed 1,100,000 organizations in 2010 with ISO 9001 series adoption and implementation governing business operations (ASQ, 2012b; ISO, 2011; Bernardo, Llach, & Marimon, 2011). Historians such as Crosby, Juran, Deming, and others established the foundation for quality assurance. Several researchers explored the issues which complicate overall benefits of ISO certification (Iwaro & Mwasha, 2012; Karthi et al., 2012; Sampaio et al., 2009). This study examined the effects on AS&D industries from ISO compliance to identify the implications (of ever-changing requirements) through an online survey of 15,000 practitioners. The research illuminated how ISO affects AS&D industries with current and future requirements for certification. The data showed that 75% of survey respondents report implementation of the AS9100C requirements still has benefits that outweigh the cost. Findings suggest that AS&D industries perceive significant value in the AS9100C document as part of the overall ISO 9000 series. In general, the comments from the survey can provide insight into the affects of ISO certification. The study concludes by recommending continued research to learn of further impacts from ISO certification within AS&D industries to improve the AS9100 document requirements for quality management systems.

  6. [Procedure of seed quality testing and seed grading standard of Prunus humilis].

    PubMed

    Wen, Hao; Ren, Guang-Xi; Gao, Ya; Luo, Jun; Liu, Chun-Sheng; Li, Wei-Dong

    2014-11-01

    So far there exists no corresponding quality test procedures and grading standards for the seed of Prunus humilis, which is one of the important source of base of semen pruni. Therefor we set up test procedures that are adapt to characteristics of the P. humilis seed through the study of the test of sampling, seed purity, thousand-grain weight, seed moisture, seed viability and germination percentage. 50 cases of seed specimens of P. humilis tested. The related data were analyzed by cluster analysis. Through this research, the seed quality test procedure was developed, and the seed quality grading standard was formulated. The seed quality of each grade should meet the following requirements: for first grade seeds, germination percentage ≥ 68%, thousand-grain weight 383 g, purity ≥ 93%, seed moisture ≤ 5%; for second grade seeds, germination percentage ≥ 26%, thousand-grain weight ≥ 266 g, purity ≥ 73%, seed moisture ≤9%; for third grade seeds, germination percentage ≥ 10%, purity ≥ 50%, thousand-grain weight ≥ 08 g, seed moisture ≤ 13%.

  7. [Comprehensive and competition-oriented quality management in social medicine expert services].

    PubMed

    Seger, W

    1996-05-01

    In free competition expert services in Social Medicine must supply their expertise with high quality in a short time and at low cost. The demands by customers in respect of motivation of the staff and innovative organisation are as important competitive factors as high quality standards for expertise production. These guiding principles completed by "Kaizen" and "Lean production" are necessary requirements for the further existence of the enterprise in competition. Quality assurance must be promoted in a process looking to the future in active quality management.

  8. Non-Hodgkin's lymphomas: clinical governance issues.

    PubMed

    Fields, P A; Goldstone, A H

    2002-09-01

    Every patient in every part of the world has the right to expect the best possible quality of care from health care providers. Non-Hodgkin's lymphomas (NHL) are an extremely heterogeneous group of conditions which require important decisions to be taken at many points along the treatment pathway. To get this right every time requires that high-quality standards are instituted and adhered to, so that the best possible outcome is achieved. In the past this has not always been the case because of the failure of clinicians sometimes to adhere to an optimal management plan. In 1995, the UK government commissioned an inquiry into the running of cancer services in the United Kingdom, which culminated in a series of recommendations to improve them. Subsequently, these recommendations were implemented as objectives of the NHS Cancer Plan which is the framework by which the UK government wishes to improve cancer services. Concurrently another general concept has emerged which is designed to ensure that the highest quality standards may be achieved for all patients across the whole National Health Service (NHS). This concept, termed 'clinical governance', brings together a corporate responsibility of all health care workers to deliver high quality standards, in the hope that this will translate into better long-term survival of patients with malignant disease. This chapter focuses on the issues surrounding clinical governance and how the principles of this concept relate to non-Hodgkin's lymphomas.

  9. Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

    PubMed

    Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

    2015-02-01

    Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  10. Image recording requirements for earth observation applications in the next decade

    NASA Technical Reports Server (NTRS)

    Peavey, B.; Sos, J. Y.

    1975-01-01

    Future requirements for satellite-borne image recording systems are examined from the standpoints of system performance, system operation, product type, and product quality. Emphasis is on total system design while keeping in mind that the image recorder or scanner is the most crucial element which will affect the end product quality more than any other element within the system. Consideration of total system design and implementation for sustained operational usage must encompass the requirements for flexibility of input data and recording speed, pixel density, aspect ratio, and format size. To produce this type of system requires solution of challenging problems in interfacing the data source with the recorder, maintaining synchronization between the data source and the recorder, and maintaining a consistent level of quality. Film products of better quality than is currently achieved in a routine manner are needed. A 0.1 pixel geometric accuracy and 0.0001 d.u. radiometric accuracy on standard (240 mm) size format should be accepted as a goal to be reached in the near future.

  11. Developing policy, standard orders, and quality-assurance monitoring for palliative sedation therapy.

    PubMed

    Ghafoor, Virginia L; Silus, Lauren S

    2011-03-15

    The development of a policy, evidence-based standard orders, and monitoring for palliative sedation therapy (PST) is described. Concerns regarding PST at the University of Minnesota Medical Center (UMMC) arose and needed to be addressed in a formal process. A multidisciplinary group consisting of palliative care physicians, nurse practitioners, clinical nurse specialists, and clinical pharmacy specialists reached consensus on the practice model and medications to be used for PST. Major elements of the plan included the development and implementation of an institutional policy for palliative sedation; standard orders for patient care, sedation, and monitoring; education for staff, patients, and patients' family members; and quality-assurance monitoring. A literature review was performed to identify research and guidelines defining the practice of PST. Policy content includes the use of a standard order set linking patient care, medication administration, the monitoring of sedation, and symptom management. Approval of the policy involved several UMMC committees. An evaluation matrix was used to determine critical areas for PST monitoring and to guide development of a form to monitor quality. A retrospective chart audit using the quality-assurance monitoring form assessed baseline sedation medication and patient outcomes. Assessment of compliance began in the fall of 2008, after the policy and standard orders were approved by the UMMC medical executive committee. In 2008, two cases of PST were monitored using the standardized form. PST cases will be continually monitored and analyzed. Development of policy, standard orders, and quality-assurance monitoring for PST required a formal multidisciplinary process. A process-improvement process is critical to defining institutional policy, educational goals, and outcome metrics for PST.

  12. 36 CFR 228.112 - Compliance and inspection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Forest officer shall give prompt written notice to an operator whenever reclamation of a portion of the... and State water quality standards, including the requirements of the Federal Water Pollution Control...

  13. 42 CFR 431.55 - Waiver of other Medicaid requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... its applicable State standards are consistent with access, quality and efficient and economic... relationship (direct or indirect) with an individual convicted of certain crimes, as described in section 1128...

  14. 42 CFR 431.55 - Waiver of other Medicaid requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... its applicable State standards are consistent with access, quality and efficient and economic... relationship (direct or indirect) with an individual convicted of certain crimes, as described in section 1128...

  15. 42 CFR 431.55 - Waiver of other Medicaid requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... its applicable State standards are consistent with access, quality and efficient and economic... relationship (direct or indirect) with an individual convicted of certain crimes, as described in section 1128...

  16. Antisense long non-coding RNAs in rainbow trout: Discovery and potential role in muscle growth and quality traits

    USDA-ARS?s Scientific Manuscript database

    Endogenous mRNA-antisense transcripts are involved in regulation of a wide range of biological processes including muscle development and quality traits of farm animals. Standard RNA-Seq can be used to identify sense-antisense transcripts. However, strand-specific RNA-Seq is required to resolve ambi...

  17. 75 FR 6473 - Primary National Ambient Air Quality Standards for Nitrogen Dioxide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... review, however, some areas could be classified as non-attainment. Certain States will be required to... sources of NO X emissions are on-road mobile sources, electricity generating units, and non-road mobile... tracking. 2. NO 2 Air Quality and Gradients Around Roadways On-road and non-road mobile sources account for...

  18. 36 CFR 1238.10 - What are the format standards for microfilming records?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... and format for meeting image quality requirements. When microfilming on 35mm film for aperture card...). The 35mm film used in the aperture card application must conform to film designated as LE 500 in ISO... used as specified for the size and quality of the documents being filmed. Use ANSI/AIIM MS23...

  19. Environmental Law

    DTIC Science & Technology

    2002-06-01

    Interior’s Bureau of Land Management (BLM). Flue - Gas Desulfurization (FGD). Post-combustion sulfur dioxide control technology in which a scrubber...4. Individual Control Strategies for Toxic Pollutants. a. The CWA requires states to identify “impaired” water bodies within their...water quality standards. Thereafter, states must develop “individual control strategies ” (ICSs) to regulate such pollutants and achieve water quality

  20. Development of Management Methodology for Engineering Production Quality

    NASA Astrophysics Data System (ADS)

    Gorlenko, O.; Miroshnikov, V.; Borbatc, N.

    2016-04-01

    The authors of the paper propose four directions of the methodology developing the quality management of engineering products that implement the requirements of new international standard ISO 9001:2015: the analysis of arrangement context taking into account stakeholders, the use of risk management, management of in-house knowledge, assessment of the enterprise activity according to the criteria of effectiveness

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