Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

PubMed

Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

2013-01-01

Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

PubMed Central

Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

2013-01-01

Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory. PMID:23869142

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true FEGLI Program quality...

21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

Code of Federal Regulations, 2010 CFR

2010-04-01

... laboratory operations associated with the production and process control system? 111.110 Section 111.110 Food... OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control... production and process control system? Quality control operations for laboratory operations associated with...

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...

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...

40 CFR 60.2735 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2011 CFR

2011-07-01

....2770(o) of this part), and required monitoring system quality assurance or quality control activities... periods, and required monitoring system quality assurance or quality control activities including, as... 40 Protection of Environment 6 2011-07-01 2011-07-01 false Is there a minimum amount of monitoring...

21 CFR 111.135 - What quality control operations are required for product complaints?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.135 What quality control operations are required for...

42 CFR 431.832 - Reporting requirements for claims processing assessment systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... assessment systems. 431.832 Section 431.832 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... GENERAL ADMINISTRATION Quality Control Medicaid Quality Control (mqc) Claims Processing Assessment System § 431.832 Reporting requirements for claims processing assessment systems. (a) The agency must submit...

40 CFR 63.7535 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2014 CFR

2014-07-01

...-control periods, or required monitoring system quality assurance or control activities in data averages... required monitoring system quality assurance or quality control activities (including, as applicable... control activities. You must calculate monitoring results using all other monitoring data collected while...

40 CFR 63.7535 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2013 CFR

2013-07-01

...-control periods, or required monitoring system quality assurance or control activities in data averages... required monitoring system quality assurance or quality control activities (including, as applicable... control activities. You must calculate monitoring results using all other monitoring data collected while...

Quality Requirements for Electronic Health Record Systems*. A Japanese-German Information Management Perspective.

PubMed

Winter, Alfred; Takabayashi, Katsuhiko; Jahn, Franziska; Kimura, Eizen; Engelbrecht, Rolf; Haux, Reinhold; Honda, Masayuki; Hübner, Ursula H; Inoue, Sozo; Kohl, Christian D; Matsumoto, Takehiro; Matsumura, Yasushi; Miyo, Kengo; Nakashima, Naoki; Prokosch, Hans-Ulrich; Staemmler, Martin

2017-08-07

For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. Donabedian's three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.

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.

40 CFR 63.10020 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2014 CFR

2014-07-01

...-of-control periods, or required monitoring system quality assurance or control activities in... monitoring system quality assurance or quality control activities including, as applicable, calibration... collect data according to this section and the site-specific monitoring plan required by § 63.10000(d). (b...

40 CFR 60.2735 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2014 CFR

2014-07-01

... activities including, as applicable, calibration checks and required zero and span adjustments. A monitoring... monitoring system quality assurance or control activities in calculations used to report emissions or...-control periods, and required monitoring system quality assurance or quality control activities including...

40 CFR 63.10020 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

...-of-control periods, or required monitoring system quality assurance or control activities in... monitoring system quality assurance or quality control activities including, as applicable, calibration... collect data according to this section and the site-specific monitoring plan required by § 63.10000(d). (b...

40 CFR 60.2735 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2013 CFR

2013-07-01

... activities including, as applicable, calibration checks and required zero and span adjustments. A monitoring... monitoring system quality assurance or control activities in calculations used to report emissions or...-control periods, and required monitoring system quality assurance or quality control activities including...

40 CFR 63.10020 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2013 CFR

2013-07-01

...-of-control periods, or required monitoring system quality assurance or control activities in... monitoring system quality assurance or quality control activities including, as applicable, calibration... collect data according to this section and the site-specific monitoring plan required by § 63.10000(d). (b...

48 CFR 46.201 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

....201 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.201 General. (a) The contracting officer shall include in the solicitation and contract the appropriate quality requirements. The type and extent of contract quality...

21 CFR 111.65 - What are the requirements for quality control operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements for quality control... Process Control System § 111.65 What are the requirements for quality control operations? You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for...

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation.

PubMed

Alemnji, George; Edghill, Lisa; Guevara, Giselle; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.

Do quality improvement systems improve health library services? A systematic review.

PubMed

Gray, Hannah; Sutton, Gary; Treadway, Victoria

2012-09-01

A turbulent financial and political climate requires health libraries to be more accountable than ever. Quality improvement systems are widely considered a 'good thing to do', but do they produce useful outcomes that can demonstrate value? To undertake a systematic review to identify which aspects of health libraries are being measured for quality, what tools are being used and what outcomes are reported following utilisation of quality improvement systems. Many health libraries utilise quality improvement systems without translating the data into service improvements. Included studies demonstrate that quality improvement systems produce valuable outcomes including a positive impact on strategic planning, promotion, new and improved services and staff development. No impact of quality improvement systems on library users or patients is reported in the literature. The literature in this area is sparse and requires updating. We recommend further primary research is conducted in health libraries focusing upon the outcomes of utilising quality improvement systems. An exploration of quality improvement systems in other library sectors may also provide valuable insight for health libraries. © 2012 The authors. Health Information and Libraries Journal © 2012 Health Libraries Group.

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...

14 CFR 21.307 - 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. 21.307 Section 21.307... PROCEDURES FOR PRODUCTS AND PARTS Parts Manufacturer Approvals § 21.307 Quality system. Each applicant for or holder of a PMA must establish a quality system that meets the requirements of § 21.137. ...

14 CFR 21.307 - Quality system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality system. 21.307 Section 21.307... PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials, Parts, Processes, and Appliances § 21.307 Quality system. Each applicant for or holder of a PMA must establish a quality system that meets the requirements...

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.

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.

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

21 CFR 111.117 - What quality control operations are required for equipment, instruments, and controls?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for equipment, instruments, and controls? 111.117 Section 111.117 Food and Drugs FOOD AND DRUG ADMINISTRATION... and Process Control System: Requirements for Quality Control § 111.117 What quality control operations...

A scope classification of data quality requirements for food composition data.

PubMed

Presser, Karl; Hinterberger, Hans; Weber, David; Norrie, Moira

2016-02-15

Data quality is an important issue when managing food composition data since the usage of the data can have a significant influence on policy making and further research. Although several frameworks for data quality have been proposed, general tools and measures are still lacking. As a first step in this direction, we investigated data quality requirements for an information system to manage food composition data, called FoodCASE. The objective of our investigation was to find out if different requirements have different impacts on the intrinsic data quality that must be regarded during data quality assessment and how these impacts can be described. We refer to the resulting classification with its categories as the scope classification of data quality requirements. As proof of feasibility, the scope classification has been implemented in the FoodCASE system. Copyright © 2015 Elsevier Ltd. All rights reserved.

Advanced control technology and airworthiness flying qualities requirements

NASA Technical Reports Server (NTRS)

Snyder, C. T.

1976-01-01

Flying quality requirements are specified in terms of the complete pilot-airframe-systems loop, the task, and the environment. Results from a study of flying qualities are reported. A review of the treatment of failure cases in various flying quality requirements is presented along with a description of the methods used and relevant lessons learned from recent Autoland certification programs.

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

75 FR 10866 - Notice of a Project Waiver of Section 1605 (Buy American Requirement) of the American Recovery...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... rotating drum filter upgrades and a water quality monitoring system expansion, are not available from... quality. Expansion of the recirculation system requires adding a second drum filter for aquaculture water treatment. The existing system uses a drum filter manufactured by PRAqua Supplies Ltd.--Nanaimo, British...

[Implementation of quality management in medical rehabilitation--current challenges for rehabilitation facilities].

PubMed

Enge, M; Koch, A; Müller, T; Vorländer, T

2010-12-01

The legal responsibilities imposed upon rehabilitation facilities under section 20 (2a) SGB IX, necessitate fundamental decisions to be taken regarding the development of quality management systems over and above the existing framework. This article is intended to provide ideas and suggestions to assist rehabilitation facilities in implementing a quality management system, which is required in addition to participation in the quality assurance programmes stipulated by the rehabilitation carriers. In this context, the additional internal benefit a functioning quality management system can provide for ensuring a high level of quality and for maintaining the competitiveness of the rehabilitation facility should be taken into account. The core element of these observations, hence, is a list of requirements which enables assessment of the quality of consultants' performance in setting up a quality management system. © Georg Thieme Verlag KG Stuttgart · New York.

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation

PubMed Central

Alemnji, George; Edghill, Lisa; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Background Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. Objectives We report the development of a stepwise process for quality systems improvement in the Caribbean Region. Methods The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called ‘Laboratory Quality Management System – Stepwise Improvement Process (LQMS-SIP) Towards Accreditation’ to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. Results This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. Conclusion This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement. PMID:28879149

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.

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

30 CFR 74.9 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 74.9 Section 74.9 Mineral... DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance. (a) General requirements. The applicant shall establish and maintain a quality control system that assures...

48 CFR 46.311 - Higher-level contract quality requirement.

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 Clauses 46.311 Higher-level contract quality requirement. The contracting officer shall insert the clause at 52.246-11, Higher-Level Contract Quality...

Preface to QoIS 2009

NASA Astrophysics Data System (ADS)

Comyn-Wattiau, Isabelle; Thalheim, Bernhard

Quality assurance is a growing research domain within the Information Systems (IS) and Conceptual Modeling (CM) disciplines. Ongoing research on quality in IS and CM is highly diverse and encompasses theoretical aspects including quality definition and quality models, and practical/empirical aspects such as the development of methods, approaches and tools for quality measurement and improvement. Current research on quality also includes quality characteristics definitions, validation instruments, methodological and development approaches to quality assurance during software and information systems development, quality monitors, quality assurance during information systems development processes and practices, quality assurance both for data and (meta)schemata, quality support for information systems data import and export, quality of query answering, and cost/benefit analysis of quality assurance processes. Quality assurance is also depending on the application area and the specific requirements in applications such as health sector, logistics, public sector, financial sector, manufacturing, services, e-commerce, software, etc. Furthermore, quality assurance must also be supported for data aggregation, ETL processes, web content management and other multi-layered applications. Quality assurance is typically requiring resources and has therefore beside its benefits a computational and economical trade-off. It is therefore also based on compromising between the value of quality data and the cost for quality assurance.

Eliciting and Analyzing Quality Requirements: Management Influences on Software Quality Requirements

DTIC Science & Technology

2005-03-01

their portable devices [ Balfanz 04] can be applied to many of the quality requirements issues within the development life cycle: " Neither usability or...Systems. New York, NY: Wiley Computer Publishing, 2001. [ Balfanz 04] Balfanz , D.; Durfee, G; & Smetters, D. K. "Search of Usable Security: Five Lessons from

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.

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

NASA Astrophysics Data System (ADS)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

Security Quality Requirements Engineering (SQUARE) Methodology

DTIC Science & Technology

2005-11-01

such as Joint Application Development and the Accelerated Requirements Method [Wood 89, Hubbard 99] • Soft Systems Methodology [Checkland 89...investigated were misuse cases [Jacobson 92], Soft Systems Methodology (SSM) [Checkland 89], Quality Function Deployment (QFD) [QFD 05], Con- trolled...html (2005). [Checkland 89] Checkland, Peter. Soft Systems Methodology . Rational Analysis for a Problematic World. New York, NY: John Wiley & Sons

Section 3: Quality and Value-Based Requirements

NASA Astrophysics Data System (ADS)

Mylopoulos, John

Traditionally, research and practice in software engineering has focused its attention on specific software qualities, such as functionality and performance. According to this perspective, a system is deemed to be of good quality if it delivers all required functionality (“fitness-for-purpose”) and its performance is above required thresholds. Increasingly, primarily in research but also in practice, other qualities are attracting attention. To facilitate evolution, maintainability and adaptability are gaining popularity. Usability, universal accessibility, innovativeness, and enjoyability are being studied as novel types of non-functional requirements that we do not know how to define, let alone accommodate, but which we realize are critical under some contingencies. The growing importance of the business context in the design of software-intensive systems has also thrust economic value, legal compliance, and potential social and ethical implications into the forefront of requirements topics. A focus on the broader user environment and experience, as well as the organizational and societal implications of system use, thus has become more central to the requirements discourse. This section includes three contributions to this broad and increasingly important topic.

48 CFR 246.402 - Government contract quality assurance at source.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.402 Government contract quality assurance at source. Do not require...

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

A network for continuous monitoring of water quality in the Sabine River basin, Texas and Louisiana

USGS Publications Warehouse

Blakey, J.F.; Skinner, P.W.

1973-01-01

Level I operations at a proposed site would monitor current and potential problems, water-quality changes in subreaches of streams, and water-quality trends in time and place. Level II operations would monitor current or potential problems only. An optimum system would require Level I operations at all nine stations. A minimum system would require Level II operations at most of the stations.

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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...

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...

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...

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...

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...

Certifying leaders? high-quality management practices and healthy organisations: an ISO-9000 based standardisation approach

PubMed Central

MONTANO, Diego

2016-01-01

The present study proposes a set of quality requirements to management practices by taking into account the empirical evidence on their potential effects on health, the systemic nature of social organisations, and the current conceptualisations of management functions within the framework of comprehensive quality management systems. Systematic reviews and meta-analyses focusing on the associations between leadership and/or supervision and health in occupational settings are evaluated, and the core elements of an ISO 9001 standardisation approach are presented. Six major occupational health requirements to high-quality management practices are identified pertaining to communication processes, organisational justice, role clarity, decision making, social influence processes and management support. It is concluded that the quality of management practices may be improved by developing a quality management system of management practices that ensures not only conformity to product but also to occupational safety and health requirements. Further research may evaluate the practicability of the proposed approach. PMID:26860787

Certifying leaders? high-quality management practices and healthy organisations: an ISO-9000 based standardisation approach.

PubMed

Montano, Diego

2016-08-05

The present study proposes a set of quality requirements to management practices by taking into account the empirical evidence on their potential effects on health, the systemic nature of social organisations, and the current conceptualisations of management functions within the framework of comprehensive quality management systems. Systematic reviews and meta-analyses focusing on the associations between leadership and/or supervision and health in occupational settings are evaluated, and the core elements of an ISO 9001 standardisation approach are presented. Six major occupational health requirements to high-quality management practices are identified pertaining to communication processes, organisational justice, role clarity, decision making, social influence processes and management support. It is concluded that the quality of management practices may be improved by developing a quality management system of management practices that ensures not only conformity to product but also to occupational safety and health requirements. Further research may evaluate the practicability of the proposed approach.

A quality system for PET: An industry perspective

NASA Astrophysics Data System (ADS)

Zigler, Steven S.; Breslow, Kenneth; Nazerias, Michael

2005-12-01

Quality systems have been employed in a variety of industries to develop and supply products that meet customer expectations and regulatory requirements. Most quality systems address organizational structure, design controls, production, complaints, audits, corrective actions and preventive actions. This paper describes PETNET's efforts to develop a quality system for use in the production of PET tracers. Our goal is to ensure quality products and to facilitate compliance with impending PET good manufacturing practice (GMP) regulations.

48 CFR 1646.201 - Contract Quality Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ensure that services acquired under the FEHB contract conform to the contract's quality and audit requirements. (b) OPM will periodically evaluate the contractor's system of internal controls under the quality... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contract Quality Policy...

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.

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

PubMed

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

High Available COTS Based Computer for Space

NASA Astrophysics Data System (ADS)

Hartmann, J.; Magistrati, Giorgio

2015-09-01

The availability and reliability factors of a system are central requirements of a target application. From a simple fuel injection system used in cars up to a flight control system of an autonomous navigating spacecraft, each application defines its specific availability factor under the target application boundary conditions. Increasing quality requirements on data processing systems used in space flight applications calling for new architectures to fulfill the availability, reliability as well as the increase of the required data processing power. Contrary to the increased quality request simplification and use of COTS components to decrease costs while keeping the interface compatibility to currently used system standards are clear customer needs. Data processing system design is mostly dominated by strict fulfillment of the customer requirements and reuse of available computer systems were not always possible caused by obsolescence of EEE-Parts, insufficient IO capabilities or the fact that available data processing systems did not provide the required scalability and performance.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

Software requirements elicitation to support internal monitoring of quality assurance system for higher education in Indonesia

NASA Astrophysics Data System (ADS)

Amalia, A.; Gunawan, D.; Hardi, S. M.; Rachmawati, D.

2018-02-01

The Internal Quality Assurance System (in Indonesian: SPMI (Sistem Penjaminan Mutu Internal) is a systemic activity of quality assurance of higher education in Indonesia. SPMI should be done by all higher education or universities in Indonesia based on the Regulation of the Minister of Research, Technology and Higher Education of the Republic of Indonesia Number 62 of 2016. Implementation of SPMI must refer to the principle of SPMI that is independent, standardize, accurate, well planned and sustainable, documented and systematic. To assist the SPMI cycle properly, universities need a supporting software to monitor all the activities of SPMI. But in reality, many universities are not optimal in building this SPMI monitoring system. One of the obstacles is the determination of system requirements in support of SPMI principles is difficult to achieve. In this paper, we observe the initial phase of the engineering requirements elicitation. Unlike other methods that collect system requirements from users and stakeholders, we find the system requirements of the SPMI principles from SPMI guideline book. The result of this paper can be used as a choice in determining SPMI software requirements. This paper can also be used by developers and users to understand the scenario of SPMI so that could overcome the problems of understanding between this two parties.

Environmental Response Laboratory Network (ERLN) Laboratory Requirements

EPA Pesticide Factsheets

The Environmental Response Laboratory Network requires its member labs follow specified quality systems, sample management, data reporting, and general, in order to ensure consistent analytical data of known and documented quality.

A Quality System Database

NASA Technical Reports Server (NTRS)

Snell, William H.; Turner, Anne M.; Gifford, Luther; Stites, William

2010-01-01

A quality system database (QSD), and software to administer the database, were developed to support recording of administrative nonconformance activities that involve requirements for documentation of corrective and/or preventive actions, which can include ISO 9000 internal quality audits and customer complaints.

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.

A new verification film system for routine quality control of radiation fields: Kodak EC-L.

PubMed

Hermann, A; Bratengeier, K; Priske, A; Flentje, M

2000-06-01

The use of modern irradiation techniques requires better verification films for determining set-up deviations and patient movements during the course of radiation treatment. This is an investigation of the image quality and time requirement of a new verification film system compared to a conventional portal film system. For conventional verifications we used Agfa Curix HT 1000 films which were compared to the new Kodak EC-L film system. 344 Agfa Curix HT 1000 and 381 Kodak EC-L portal films of different tumor sites (prostate, rectum, head and neck) were visually judged on a light box by 2 experienced physicians. Subjective judgement of image quality, masking of films and time requirement were checked. In this investigation 68% of 175 Kodak EC-L ap/pa-films were judged "good", only 18% were classified "moderate" or "poor" 14%, but only 22% of 173 conventional ap/pa verification films (Agfa Curix HT 1000) were judged to be "good". The image quality, detail perception and time required for film inspection of the new Kodak EC-L film system was significantly improved when compared with standard portal films. They could be read more accurately and the detection of set-up deviation was facilitated.

40 CFR 63.11221 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2013 CFR

2013-07-01

...-control periods, and required monitoring system quality assurance or quality control activities including... monitoring system quality assurance or quality control activities in calculations used to report emissions or... monitoring data I must obtain? 63.11221 Section 63.11221 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 60.2170 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2014 CFR

2014-07-01

... monitoring system quality assurance or quality control activities (including, as applicable, calibration... required monitoring system quality assurance or quality control activities including, as applicable... 40 Protection of Environment 7 2014-07-01 2014-07-01 false Is there a minimum amount of monitoring...

40 CFR 63.11221 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2014 CFR

2014-07-01

...-control periods, and required monitoring system quality assurance or quality control activities including... monitoring system quality assurance or quality control activities in calculations used to report emissions or... monitoring data I must obtain? 63.11221 Section 63.11221 Protection of Environment ENVIRONMENTAL PROTECTION...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

21 CFR 820.180 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DEVICES QUALITY SYSTEM REGULATION Records § 820.180 General requirements. All records required by this... retained for a period of time equivalent to the design and expected life of the device, but in no case less.... This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality...

A measurement system for large, complex software programs

NASA Technical Reports Server (NTRS)

Rone, Kyle Y.; Olson, Kitty M.; Davis, Nathan E.

1994-01-01

This paper describes measurement systems required to forecast, measure, and control activities for large, complex software development and support programs. Initial software cost and quality analysis provides the foundation for meaningful management decisions as a project evolves. In modeling the cost and quality of software systems, the relationship between the functionality, quality, cost, and schedule of the product must be considered. This explicit relationship is dictated by the criticality of the software being developed. This balance between cost and quality is a viable software engineering trade-off throughout the life cycle. Therefore, the ability to accurately estimate the cost and quality of software systems is essential to providing reliable software on time and within budget. Software cost models relate the product error rate to the percent of the project labor that is required for independent verification and validation. The criticality of the software determines which cost model is used to estimate the labor required to develop the software. Software quality models yield an expected error discovery rate based on the software size, criticality, software development environment, and the level of competence of the project and developers with respect to the processes being employed.

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

[Designing and implementation of a web-based quality monitoring system for plasma glucose measurement in multicenter population study].

PubMed

Liu, Yong; Wang, Limin; Pang, Richard; Mo, Nanxun; Hu, Yan; Deng, Qian; Hu, Zhaohui

2015-05-01

The aim of this paper is to describe the designing and implementation of a web-based plasma glucose measurement quality monitoring system to assess the analytical quality of plasma glucose measurements in multicenter population study and provide evidence for the future studies. In the chronic non-communicable disease and related factor surveillance in China, a web based quality monitoring system for plasma glucose measurement was established to conduct evaluation on plasma glucose monitoring quality and effectiveness in 302 surveillance centers, including quality control data entry, transmission and feedback. The majority of the surveillance centers met the quality requirements and passed the evaluation of reproducibility and precision of plasma glucose measurement, only a few centers required intensive training and re-assessment. In order to ensure the completeness and reliability of plasma glucose measurement in the surveillance centers, the establishment of web-based plasma glucose measurement quality control system can facilitate the identification of the qualified surveillance centers and evaluation of plasma glucose measurement quality in different regions. Communication and training are important in ensuring plasma glucose measurement quality. It is necessary to further improve this web-based plasma glucose measurement quality monitoring system in the future to reduce the method specific plasma glucose measurement bias.

A Theory of Information Quality and a Framework for its Implementation in the Requirements Engineering Process

NASA Astrophysics Data System (ADS)

Grenn, Michael W.

This dissertation introduces a theory of information quality to explain macroscopic behavior observed in the systems engineering process. The theory extends principles of Shannon's mathematical theory of communication [1948] and statistical mechanics to information development processes concerned with the flow, transformation, and meaning of information. The meaning of requirements information in the systems engineering context is estimated or measured in terms of the cumulative requirements quality Q which corresponds to the distribution of the requirements among the available quality levels. The requirements entropy framework (REF) implements the theory to address the requirements engineering problem. The REF defines the relationship between requirements changes, requirements volatility, requirements quality, requirements entropy and uncertainty, and engineering effort. The REF is evaluated via simulation experiments to assess its practical utility as a new method for measuring, monitoring and predicting requirements trends and engineering effort at any given time in the process. The REF treats the requirements engineering process as an open system in which the requirements are discrete information entities that transition from initial states of high entropy, disorder and uncertainty toward the desired state of minimum entropy as engineering effort is input and requirements increase in quality. The distribution of the total number of requirements R among the N discrete quality levels is determined by the number of defined quality attributes accumulated by R at any given time. Quantum statistics are used to estimate the number of possibilities P for arranging R among the available quality levels. The requirements entropy H R is estimated using R, N and P by extending principles of information theory and statistical mechanics to the requirements engineering process. The information I increases as HR and uncertainty decrease, and the change in information AI needed to reach the desired state of quality is estimated from the perspective of the receiver. The HR may increase, decrease or remain steady depending on the degree to which additions, deletions and revisions impact the distribution of R among the quality levels. Current requirements trend metrics generally treat additions, deletions and revisions the same and simply measure the quantity of these changes over time. The REF evaluates the quantity of requirements changes over time, distinguishes between their positive and negative effects by calculating their impact on HR, Q, and AI, and forecasts when the desired state will be reached, enabling more accurate assessment of the status and progress of the requirements engineering effort. Results from random variable simulations suggest the REF is an improved leading indicator of requirements trends that can be readily combined with current methods. The increase in I, or decrease in H R and uncertainty, is proportional to the engineering effort E input into the requirements engineering process. The REF estimates the AE needed to transition R from their current state of quality to the desired end state or some other interim state of interest. Simulation results are compared with measured engineering effort data for Department of Defense programs published in the SE literature, and the results suggest the REF is a promising new method for estimation of AE.

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

PubMed Central

Tu, Pei-Weng; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

PubMed

Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

2015-01-01

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

Assessment of flying-quality criteria for air-breathing aerospacecraft

NASA Technical Reports Server (NTRS)

Mcruer, Duane T.; Myers, Thomas T.; Hoh, Roger H.; Ashkenas, Irving L.; Johnston, Donald E.

1992-01-01

A study of flying quality requirements for air breathing aerospacecraft gives special emphasis to the unusual operational requirements and characteristics of these aircraft, including operation at hypersonic speed. The report considers distinguishing characteristics of these vehicles, including dynamic deficiencies and their implications for control. Particular emphasis is given to the interaction of the airframe and propulsion system, and the requirements for dynamic systems integration. Past operational missions are reviewed to define tasks and maneuvers to be considered for this class of aircraft. Areas of special concern with respect to vehicle dynamics and control are identified. Experience with the space shuttle orbiter is reviewed with respect to flight control system mechanization and flight experience in approach and landing flying qualities for the National Aerospace Plane (NASP).

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…

Quality assurance paradigms for artificial intelligence in modelling and simulation

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

Oren, T.I.

1987-04-01

New classes of quality assurance concepts and techniques are required for the advanced knowledge-processing paradigms (such as artificial intelligence, expert systems, or knowledge-based systems) and the complex problems that only simulative systems can cope with. A systematization of quality assurance problems as well as examples are given to traditional and cognizant quality assurance techniques in traditional and cognizant modelling and simulation.

National quality improvement policies and strategies in European healthcare systems.

PubMed

Spencer, E; Walshe, K

2009-02-01

This survey provides an overview of the development of policies and strategies for quality improvement in European healthcare systems, by mapping quality improvement policies and strategies, progress in their implementation, and early indications of their impact. A survey of quality improvement policies and strategies in healthcare systems of the European Union was conducted in 2005 for the first phase of the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) project. The survey, completed by 68 key experts in quality improvement from 24 European Union member states, represents their views and accounts of quality improvement policies and strategies in their healthcare systems. There are substantial international and intra-national variations in the development of healthcare quality improvement. Legal requirements for quality improvement strategies are an important driver of progress, along with the activities of national governments and professional associations and societies. Patient and service user organisations appear to have less influence on quality improvement. Wide variation in voluntary and mandatory coverage of quality improvement policies and strategies across sectors can potentially lead to varying levels of progress in implementation. Many healthcare organisations lack basic infrastructure for quality improvement. Some convergence can be observed in policies on quality improvement in healthcare. Nevertheless, the growth of patient mobility across borders, along with the implications of free market provisions for the organisation and funding of healthcare systems in European Union member states, require policies for cooperation and learning transfer.

21 CFR 820.20 - Management responsibility.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and...

21 CFR 820.20 - Management responsibility.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and...

21 CFR 820.20 - Management responsibility.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and...

21 CFR 820.20 - Management responsibility.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and...

21 CFR 820.20 - Management responsibility.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Management responsibility. 820.20 Section 820.20...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and...

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... processing assessment system. Except in a State that has an approved Medicaid Management Information System... Medicaid quality control claims processing assessment system that meets the requirements of §§ 431.830...

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...

A review of approaches to quality assurance of veterinary systems for health-status certification.

PubMed

Stärk, Katharina D C; Salman, Mo; Tempelman, Yuval; Kihm, Ulrich

2002-12-18

Regarding national and international trade of animals and animal products, certificates are required to document specific health levels. The credibility of such certificates depends on the quality of the data used to establish the status. Credibility also depends on the quality of the design and protocols used in the data-gathering process (i.e. on the quality of the surveillance-and-monitoring systems (SMS) and on the quality of the veterinary administrative systems (VAdminS)). The major requirements for the assessment of the SMS and VAdminS are: objectivity, accuracy, transparency, practicality, quantitative in nature. To assess the quality of SMS and VAdminS, systems analysis might provide a suitable framework. Systems analysis requires the identification and description of all components of the system-how they interact with each other and with other systems. Graphical methods (e.g. fault trees) are available to support this procedure. To assess the quality of SMS, scoring systems have been suggested. Their main weakness is the inherent subjectiveness. Alternatively, performance indicators (PI) could be used. For the assessment of VAdminS, questionnaires have been developed and applied. Their main limitations are that they focus on the input rather than on the output and that they are purely descriptive in nature. Thus, comparisons between countries are almost impossible. Semi-quantitative questionnaires using scores now are being developed and tested, although their limitations will be similar to those mentioned above. Another approach is the use of risk assessment including standardised data files assembled by countries volunteering to be assessed. This was applied successfully by the European Union (EU) in the geographic risk assessment for bovine spongiform encephalopathy (BSE). In general, the publication and documentation of veterinary systems needs to be encouraged to make them accessible to peer review.

NTP comparison process

NASA Technical Reports Server (NTRS)

Corban, Robert

1993-01-01

The systems engineering process for the concept definition phase of the program involves requirements definition, system definition, and consistent concept definition. The requirements definition process involves obtaining a complete understanding of the system requirements based on customer needs, mission scenarios, and nuclear thermal propulsion (NTP) operating characteristics. A system functional analysis is performed to provide a comprehensive traceability and verification of top-level requirements down to detailed system specifications and provides significant insight into the measures of system effectiveness to be utilized in system evaluation. The second key element in the process is the definition of system concepts to meet the requirements. This part of the process involves engine system and reactor contractor teams to develop alternative NTP system concepts that can be evaluated against specific attributes, as well as a reference configuration against which to compare system benefits and merits. Quality function deployment (QFD), as an excellent tool within Total Quality Management (TQM) techniques, can provide the required structure and provide a link to the voice of the customer in establishing critical system qualities and their relationships. The third element of the process is the consistent performance comparison. The comparison process involves validating developed concept data and quantifying system merits through analysis, computer modeling, simulation, and rapid prototyping of the proposed high risk NTP subsystems. The maximum amount possible of quantitative data will be developed and/or validated to be utilized in the QFD evaluation matrix. If upon evaluation of a new concept or its associated subsystems determine to have substantial merit, those features will be incorporated into the reference configuration for subsequent system definition and comparison efforts.

Human visual system consistent quality assessment for remote sensing image fusion

NASA Astrophysics Data System (ADS)

Liu, Jun; Huang, Junyi; Liu, Shuguang; Li, Huali; Zhou, Qiming; Liu, Junchen

2015-07-01

Quality assessment for image fusion is essential for remote sensing application. Generally used indices require a high spatial resolution multispectral (MS) image for reference, which is not always readily available. Meanwhile, the fusion quality assessments using these indices may not be consistent with the Human Visual System (HVS). As an attempt to overcome this requirement and inconsistency, this paper proposes an HVS-consistent image fusion quality assessment index at the highest resolution without a reference MS image using Gaussian Scale Space (GSS) technology that could simulate the HVS. The spatial details and spectral information of original and fused images are first separated in GSS, and the qualities are evaluated using the proposed spatial and spectral quality index respectively. The overall quality is determined without a reference MS image by a combination of the proposed two indices. Experimental results on various remote sensing images indicate that the proposed index is more consistent with HVS evaluation compared with other widely used indices that may or may not require reference images.

40 CFR 60.2735 - Is there a minimum amount of monitoring data I must obtain?

Code of Federal Regulations, 2012 CFR

2012-07-01

... monitoring malfunctions, associated repairs, and required quality assurance or quality control activities for... periods, or required monitoring system quality assurance or control activities in calculations used to... 40 Protection of Environment 7 2012-07-01 2012-07-01 false Is there a minimum amount of monitoring...

Ontario's Quality Assurance Framework: A Critical Response

ERIC Educational Resources Information Center

Heap, James

2013-01-01

Ontario's Quality Assurance Framework (QAF) is reviewed and found not to meet all five criteria proposed for a strong quality assurance system focused on student learning. The QAF requires a statement of student learning outcomes and a method and means of assessing those outcomes, but it does not require that data on achievement of intended…

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

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality system in terms of the organizational structure, functional responsibilities of management and... more stringent requirements. Monitoring organizations may, based on their quality objectives, develop... infrequent work with EPA funds may combine the QMP with the QAPP based on negotiations with the funding...

[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.

Overview of the EPA Quality System for Environmental Data and Technology

EPA Pesticide Factsheets

This document provides a brief summary of EPA’s Quality System for environmental data and technology for EPA and non-EPA organizations who are not familiar with the system but are subject to its requirements.

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...

Software Requirements Analysis as Fault Predictor

NASA Technical Reports Server (NTRS)

Wallace, Dolores

2003-01-01

Waiting until the integration and system test phase to discover errors leads to more costly rework than resolving those same errors earlier in the lifecycle. Costs increase even more significantly once a software system has become operational. WE can assess the quality of system requirements, but do little to correlate this information either to system assurance activities or long-term reliability projections - both of which remain unclear and anecdotal. Extending earlier work on requirements accomplished by the ARM tool, measuring requirements quality information against code complexity and test data for the same system may be used to predict specific software modules containing high impact or deeply embedded faults now escaping in operational systems. Such knowledge would lead to more effective and efficient test programs. It may enable insight into whether a program should be maintained or started over.

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.

Food and nutritional security requires adequate protein as well as energy, delivered from whole-year crop production.

PubMed

Coles, Graeme D; Wratten, Stephen D; Porter, John R

2016-01-01

Human food security requires the production of sufficient quantities of both high-quality protein and dietary energy. In a series of case-studies from New Zealand, we show that while production of food ingredients from crops on arable land can meet human dietary energy requirements effectively, requirements for high-quality protein are met more efficiently by animal production from such land. We present a model that can be used to assess dietary energy and quality-corrected protein production from various crop and crop/animal production systems, and demonstrate its utility. We extend our analysis with an accompanying economic analysis of commercially-available, pre-prepared or simply-cooked foods that can be produced from our case-study crop and animal products. We calculate the per-person, per-day cost of both quality-corrected protein and dietary energy as provided in the processed foods. We conclude that mixed dairy/cropping systems provide the greatest quantity of high-quality protein per unit price to the consumer, have the highest food energy production and can support the dietary requirements of the highest number of people, when assessed as all-year-round production systems. Global food and nutritional security will largely be an outcome of national or regional agroeconomies addressing their own food needs. We hope that our model will be used for similar analyses of food production systems in other countries, agroecological zones and economies.

Enhanced job control language procedures for the SIMSYS2D two-dimensional water-quality simulation system

USGS Publications Warehouse

Karavitis, G.A.

1984-01-01

The SIMSYS2D two-dimensional water-quality simulation system is a large-scale digital modeling software system used to simulate flow and transport of solutes in freshwater and estuarine environments. Due to the size, processing requirements, and complexity of the system, there is a need to easily move the system and its associated files between computer sites when required. A series of job control language (JCL) procedures was written to allow transferability between IBM and IBM-compatible computers. (USGS)

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...

Defining quality for distal pancreatectomy: does the laparoscopic approach protect patients from poor quality outcomes?

PubMed

Baker, Marshall S; Sherman, Karen L; Stocker, Susan; Hayman, Amanda V; Bentrem, David J; Prinz, Richard A; Talamonti, Mark S

2013-02-01

Established systems for grading postoperative complications do not change the assigned grade when multiple interventions or readmissions are required to manage a complication. Studies using these systems may misrepresent outcomes for the surgical procedures being evaluated. We define a quality outcome for distal pancreatectomy (DP) and use this metric to compare laparoscopic distal pancreatectomy (LDP) to open distal pancreatectomy (ODP). Records for patients undergoing DP between January 2006 and December 2009 were reviewed. Clavien-Dindo grade IIIb, IV, and V complications were classified as severe adverse--poor quality--postoperative outcomes (SAPOs). II and IIIa complications requiring either significantly prolonged overall lengths of stay including readmissions within 90 days or more than one invasive intervention were also classified as SAPOs. By Clavien-Dindo system alone, 91 % of DP patients had either no complication or a low/moderate grade (I, II, IIIa) complication. Using our reclassification, however, 25 % had a SAPO. Patients undergoing LDP demonstrated a Clavien-Dindo complication profile identical to that for SDP but demonstrated significantly shorter overall lengths of stay, were less likely to require perioperative transfusion, and less likely to have a SAPO. Established systems undergrade the severity of some complications following DP. Using a procedure-specific metric for quality, we demonstrate that LDP affords a higher quality postoperative outcome than ODP.

48 CFR 46.204 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false [Reserved] 46.204 Section 46.204 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.204 [Reserved] ...

The Definition and Measurement of Evaluation Quality as a Management Tool.

ERIC Educational Resources Information Center

Chelimsky, Eleanor

1983-01-01

Evaluation management requires a system for measuring, improving, and accounting for quality. The Institute for Program Evaluation in the United States General Accounting Office is developing such a system. (Author)

48 CFR 46.401 - General.

Code of Federal Regulations, 2012 CFR

2012-10-01

....401 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 46.401 General. (a) Government contract quality assurance... conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction...

48 CFR 46.401 - General.

Code of Federal Regulations, 2014 CFR

2014-10-01

....401 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 46.401 General. (a) Government contract quality assurance... conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction...

48 CFR 46.401 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

....401 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 46.401 General. (a) Government contract quality assurance... conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction...

48 CFR 46.401 - General.

Code of Federal Regulations, 2013 CFR

2013-10-01

....401 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 46.401 General. (a) Government contract quality assurance... conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction...

48 CFR 46.401 - General.

Code of Federal Regulations, 2011 CFR

2011-10-01

....401 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 46.401 General. (a) Government contract quality assurance... conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction...

Quality Attributes for Mission Flight Software: A Reference for Architects

NASA Technical Reports Server (NTRS)

Wilmot, Jonathan; Fesq, Lorraine; Dvorak, Dan

2016-01-01

In the international standards for architecture descriptions in systems and software engineering (ISO/IEC/IEEE 42010), "concern" is a primary concept that often manifests itself in relation to the quality attributes or "ilities" that a system is expected to exhibit - qualities such as reliability, security and modifiability. One of the main uses of an architecture description is to serve as a basis for analyzing how well the architecture achieves its quality attributes, and that requires architects to be as precise as possible about what they mean in claiming, for example, that an architecture supports "modifiability." This paper describes a table, generated by NASA's Software Architecture Review Board, which lists fourteen key quality attributes, identifies different important aspects of each quality attribute and considers each aspect in terms of requirements, rationale, evidence, and tactics to achieve the aspect. This quality attribute table is intended to serve as a guide to software architects, software developers, and software architecture reviewers in the domain of mission-critical real-time embedded systems, such as space mission flight software.

40 CFR 35.2015 - State priority system and project priority list.

Code of Federal Regulations, 2010 CFR

2010-07-01

... achieve optimum water quality management consistent with the goals and requirements of the Act. All..., needs and priorities set forth in areawide water quality management plans, and any other factors... priority to projects in priority water quality areas. The priority system may also include the...

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.

An approach to quality and security of supply for single-use bioreactors.

PubMed

Barbaroux, Magali; Gerighausen, Susanne; Hackel, Heiko

2014-01-01

Single-use systems (also referred to as disposables) have become a huge part of the bioprocessing industry, which raised concern in the industry regarding quality and security of supply. Processes must be in place to assure the supply and control of outsourced activities and quality of purchased materials along the product life cycle. Quality and security of supply for single-use bioreactors (SUBs) are based on a multidisciplinary approach. Developing a state-of-the-art SUB-system based on quality by design (QbD) principles requires broad expertise and know-how including the cell culture application, polymer chemistry, regulatory requirements, and a deep understanding of the biopharmaceutical industry. Using standardized products reduces the complexity and strengthens the robustness of the supply chain. Well-established supplier relations including risk mitigation strategies are the basis for achieving long-term security of supply. Well-developed quality systems including change control approaches aligned with the requirements of the biopharmaceutical industry are a key factor in supporting long-term product availability. This chapter outlines the approach to security of supply for key materials used in single-use production processes for biopharmaceuticals from a supplier perspective.

Multicriteria Gain Tuning for Rotorcraft Flight Controls (also entitled The Development of the Conduit Advanced Control System Design and Evaluation Interface with a Case Study Application Fly by Wire Helicopter Design)

NASA Technical Reports Server (NTRS)

Biezad, Daniel

1997-01-01

Handling qualities analysis and control law design would seem to be naturally complimenting components of aircraft flight control system design, however these two closely coupled disciplines are often not well integrated in practice. Handling qualities engineers and control system engineers may work in separate groups within an aircraft company. Flight control system engineers and handling quality specialists may come from different backgrounds and schooling and are often not aware of the other group's research. Thus while the handling qualities specifications represent desired aircraft response characteristics, these are rarely incorporated directly in the control system design process. Instead modem control system design techniques are based on servo-loop robustness specifications, and simple representations of the desired control response. Comprehensive handling qualities analysis is often left until the end of the design cycle and performed as a check of the completed design for satisfactory performance. This can lead to costly redesign or less than satisfactory aircraft handling qualities when the flight testing phase is reached. The desire to integrate the fields of handling qualities and flight,control systems led to the development of the CONDUIT system. This tool facilitates control system designs that achieve desired handling quality requirements and servo-loop specifications in a single design process. With CONDUIT, the control system engineer is now able to directly design and control systems to meet the complete handling specifications. CONDUIT allows the designer to retain a preferred control law structure, but then tunes the system parameters to meet the handling quality requirements.

40 CFR 142.306 - What are the responsibilities of the public water system, State and the Administrator in ensuring...

Code of Federal Regulations, 2010 CFR

2010-07-01

... meets the source water quality requirements for installing the small system variance technology...: (i) The quality of the source water for the public water system; and (ii) Removal efficiencies and expected useful life of the small system variance technology. ...

40 CFR 142.306 - What are the responsibilities of the public water system, State and the Administrator in ensuring...

Code of Federal Regulations, 2011 CFR

2011-07-01

... meets the source water quality requirements for installing the small system variance technology...: (i) The quality of the source water for the public water system; and (ii) Removal efficiencies and expected useful life of the small system variance technology. ...

ISO 9000 and/or Systems Engineering Capability Maturity Model?

NASA Technical Reports Server (NTRS)

Gholston, Sampson E.

2002-01-01

For businesses and organizations to remain competitive today they must have processes and systems in place that will allow them to first identify customer needs and then develop products/processes that will meet or exceed the customers needs and expectations. Customer needs, once identified, are normally stated as requirements. Designers can then develop products/processes that will meet these requirements. Several functions, such as quality management and systems engineering management are used to assist product development teams in the development process. Both functions exist in all organizations and both have a similar objective, which is to ensure that developed processes will meet customer requirements. Are efforts in these organizations being duplicated? Are both functions needed by organizations? What are the similarities and differences between the functions listed above? ISO 9000 is an international standard of goods and services. It sets broad requirements for the assurance of quality and for management's involvement. It requires organizations to document the processes and to follow these documented processes. ISO 9000 gives customers assurance that the suppliers have control of the process for product development. Systems engineering can broadly be defined as a discipline that seeks to ensure that all requirements for a system are satisfied throughout the life of the system by preserving their interrelationship. The key activities of systems engineering include requirements analysis, functional analysis/allocation, design synthesis and verification, and system analysis and control. The systems engineering process, when followed properly, will lead to higher quality products, lower cost products, and shorter development cycles. The System Engineering Capability Maturity Model (SE-CMM) will allow companies to measure their system engineering capability and continuously improve those capabilities. ISO 9000 and SE-CMM seem to have a similar objective, which is to document the organization's processes and certify to potential customers the capability of a supplier to control the processes that determine the quality of the product or services being produced. The remaining sections of this report examine the differences and similarities between ISO 9000 and SE-CMM and make recommendations for implementation.

Design methods, selection, and cost-effectiveness of stormwater quality structures

DOT National Transportation Integrated Search

2000-11-01

Implementation of the National Pollutant Discharge Elimination System (NPDES) and Texas Pollutant : Discharge Elimination System (TPDES) requires that the Texas Department of Transportation (TxDOT) : adopt a variety of stormwater quality measures to ...

Metrology: Calibration and measurement processes guidelines

NASA Technical Reports Server (NTRS)

Castrup, Howard T.; Eicke, Woodward G.; Hayes, Jerry L.; Mark, Alexander; Martin, Robert E.; Taylor, James L.

1994-01-01

The guide is intended as a resource to aid engineers and systems contracts in the design, implementation, and operation of metrology, calibration, and measurement systems, and to assist NASA personnel in the uniform evaluation of such systems supplied or operated by contractors. Methodologies and techniques acceptable in fulfilling metrology quality requirements for NASA programs are outlined. The measurement process is covered from a high level through more detailed discussions of key elements within the process, Emphasis is given to the flowdown of project requirements to measurement system requirements, then through the activities that will provide measurements with defined quality. In addition, innovations and techniques for error analysis, development of statistical measurement process control, optimization of calibration recall systems, and evaluation of measurement uncertainty are presented.

International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

PubMed

2009-04-08

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

48 CFR 46.202-1 - Contracts for commercial items.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202-1 Contracts for commercial items... quality assurance systems as a substitute for Government inspection and testing before tender for...

Moving beyond quality control in diagnostic radiology and the role of the clinically qualified medical physicist.

PubMed

Delis, H; Christaki, K; Healy, B; Loreti, G; Poli, G L; Toroi, P; Meghzifene, A

2017-09-01

Quality control (QC), according to ISO definitions, represents the most basic level of quality. It is considered to be the snapshot of the performance or the characteristics of a product or service, in order to verify that it complies with the requirements. Although it is usually believed that "the role of medical physicists in Diagnostic Radiology is QC", this, not only limits the contribution of medical physicists, but is also no longer adequate to meet the needs of Diagnostic Radiology in terms of Quality. In order to assure quality practices more organized activities and efforts are required in the modern era of diagnostic radiology. The complete system of QC is just one element of a comprehensive quality assurance (QA) program that aims at ensuring that the requirements of quality of a product or service will consistently be fulfilled. A comprehensive Quality system, starts even before the procurement of any equipment, as the need analysis and the development of specifications are important components under the QA framework. Further expanding this framework of QA, a comprehensive Quality Management System can provide additional benefits to a Diagnostic Radiology service. Harmonized policies and procedures and elements such as mission statement or job descriptions can provide clarity and consistency in the services provided, enhancing the outcome and representing a solid platform for quality improvement. The International Atomic Energy Agency (IAEA) promotes this comprehensive quality approach in diagnostic imaging and especially supports the field of comprehensive clinical audits as a tool for quality improvement. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

48 CFR 246.704 - Authority for use of warranties.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Warranties 246.704 Authority for use... quality assurance provisions that reference higher-level contract quality requirements (see 246.202-4); or...

48 CFR 2146.201 - General.

Code of Federal Regulations, 2012 CFR

2012-10-01

... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

48 CFR 2146.201 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

48 CFR 2146.201 - General.

Code of Federal Regulations, 2013 CFR

2013-10-01

... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

48 CFR 2146.201 - General.

Code of Federal Regulations, 2011 CFR

2011-10-01

... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

48 CFR 2146.201 - General.

Code of Federal Regulations, 2014 CFR

2014-10-01

... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

Water quality

USDA-ARS?s Scientific Manuscript database

Aquatic animals are healthiest and grow best when environmental conditions are within certain ranges that define, for a particular species, “good” water quality. From the outset, successful aquaculture requires a high-quality water supply. Water quality in aquaculture systems also deteriorates as an...

[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.

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.…

[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.

[Accession to the PIC/S and pharmaceutical quality system in Japan].

PubMed

Katori, Noriko

2014-01-01

In March, 2012, Japan made the application for membership of the Pharmaceutical Inspection convention and Pharmaceutical Inspection Co-operation scheme (PIC/S) which is an international body of a GMP inspection. The globalization of pharmaceutical manufacturing and sales has been a driving force behind the decision to become a PIC/S member. For the application for membership, Japan's GMP inspectorate needs to fulfill PIC/S requirements, for example, the inspection organization has to have a quality system as a global standard. One of the other requirements is that the GMP inspectorate can access Official Medicines Control Laboratories (OMCL) having high analytical skills and also have a quality system based on ISO 17025. I would like to describe the process to make up a quality system in the National Institute of Health Sciences and also the circumstances around the PIC/S application in Japan.

An Architecture for Continuous Data Quality Monitoring in Medical Centers.

PubMed

Endler, Gregor; Schwab, Peter K; Wahl, Andreas M; Tenschert, Johannes; Lenz, Richard

2015-01-01

In the medical domain, data quality is very important. Since requirements and data change frequently, continuous and sustainable monitoring and improvement of data quality is necessary. Working together with managers of medical centers, we developed an architecture for a data quality monitoring system. The architecture enables domain experts to adapt the system during runtime to match their specifications using a built-in rule system. It also allows arbitrarily complex analyses to be integrated into the monitoring cycle. We evaluate our architecture by matching its components to the well-known data quality methodology TDQM.

High-volume image quality assessment systems: tuning performance with an interactive data visualization tool

NASA Astrophysics Data System (ADS)

Bresnahan, Patricia A.; Pukinskis, Madeleine; Wiggins, Michael

1999-03-01

Image quality assessment systems differ greatly with respect to the number and types of mags they need to evaluate, and their overall architectures. Managers of these systems, however, all need to be able to tune and evaluate system performance, requirements often overlooked or under-designed during project planning. Performance tuning tools allow users to define acceptable quality standards for image features and attributes by adjusting parameter settings. Performance analysis tools allow users to evaluate and/or predict how well a system performs in a given parameter state. While image assessment algorithms are becoming quite sophisticated, duplicating or surpassing the human decision making process in their speed and reliability, they often require a greater investment in 'training' or fine tuning of parameters in order to achieve optimum performance. This process may involve the analysis of hundreds or thousands of images, generating a large database of files and statistics that can be difficult to sort through and interpret. Compounding the difficulty is the fact that personnel charged with tuning and maintaining the production system may not have the statistical or analytical background required for the task. Meanwhile, hardware innovations have greatly increased the volume of images that can be handled in a given time frame, magnifying the consequences of running a production site with an inadequately tuned system. In this paper, some general requirements for a performance evaluation and tuning data visualization system are discussed. A custom engineered solution to the tuning and evaluation problem is then presented, developed within the context of a high volume image quality assessment, data entry, OCR, and image archival system. A key factor influencing the design of the system was the context-dependent definition of image quality, as perceived by a human interpreter. This led to the development of a five-level, hierarchical approach to image quality evaluation. Lower-level pass-fail conditions and decision rules were coded into the system. Higher-level image quality states were defined by allowing the users to interactively adjust the system's sensitivity to various image attributes by manipulating graphical controls. Results were presented in easily interpreted bar graphs. These graphs were mouse- sensitive, allowing the user to more fully explore the subsets of data indicated by various color blocks. In order to simplify the performance evaluation and tuning process, users could choose to view the results of (1) the existing system parameter state, (2) the results of any arbitrary parameter values they chose, or (3) the results of a quasi-optimum parameter state, derived by applying a decision rule to a large set of possible parameter states. Giving managers easy- to-use tools for defining the more subjective aspects of quality resulted in a system that responded to contextual cues that are difficult to hard-code. It had the additional advantage of allowing the definition of quality to evolve over time, as users became more knowledgeable as to the strengths and limitations of an automated quality inspection system.

75 FR 54921 - Withdrawal of Regulatory Guides 1.38, 1.94, and 1.116

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

....116, ``Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical....116, ``Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems,'' dated May 1977. Regulatory Guide 1.38 endorses the American Society of Mechanical...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Earth Observatory Satellite system definition study. Report no. 5: System design and specifications. Part 1: Observatory system element specifications

NASA Technical Reports Server (NTRS)

1974-01-01

The performance, design, and quality assurance requirements for the Earth Observatory Satellite (EOS) Observatory and Ground System program elements required to perform the Land Resources Management (LRM) A-type mission are presented. The requirements for the Observatory element with the exception of the instruments specifications are contained in the first part.

Using adapted quality-improvement approaches to strengthen community-based health systems and improve care in high HIV-burden sub-Saharan African countries.

PubMed

Horwood, Christiane M; Youngleson, Michele S; Moses, Edward; Stern, Amy F; Barker, Pierre M

2015-07-01

Achieving long-term retention in HIV care is an important challenge for HIV management and achieving elimination of mother-to-child transmission. Sustainable, affordable strategies are required to achieve this, including strengthening of community-based interventions. Deployment of community-based health workers (CHWs) can improve health outcomes but there is a need to identify systems to support and maintain high-quality performance. Quality-improvement strategies have been successfully implemented to improve quality and coverage of healthcare in facilities and could provide a framework to support community-based interventions. Four community-based quality-improvement projects from South Africa, Malawi and Mozambique are described. Community-based improvement teams linked to the facility-based health system participated in learning networks (modified Breakthrough Series), and used quality-improvement methods to improve process performance. Teams were guided by trained quality mentors who used local data to help nurses and CHWs identify gaps in service provision and test solutions. Learning network participants gathered at intervals to share progress and identify successful strategies for improvement. CHWs demonstrated understanding of quality-improvement concepts, tools and methods, and implemented quality-improvement projects successfully. Challenges of using quality-improvement approaches in community settings included adapting processes, particularly data reporting, to the education level and first language of community members. Quality-improvement techniques can be implemented by CHWs to improve outcomes in community settings but these approaches require adaptation and additional mentoring support to be successful. More research is required to establish the effectiveness of this approach on processes and outcomes of care.

Small satellite product assurance

NASA Astrophysics Data System (ADS)

Demontlivault, J.; Cadelec, Jacques

1993-01-01

In order to increase the interest in small satellites, their cost must be reduced; reducing product assurance costs induced by quality requirements is a major objective. For a logical approach, small satellites are classified in three main categories: satellites for experimental operations with a short lifetime, operational satellites manufactured in small mass with long lifetime requirements, operational satellites (long lifetime required), of which only a few models are produced. The various requirements as regards the product assurance are examined for each satellite category: general requirements for space approach, reliability, electronic components, materials and processes, quality assurance, documentation, tests, and management. Ideal product assurance system integrates quality teams and engineering teams.

Flexible optical metrology strategies for the control and quality assurance of small series production

NASA Astrophysics Data System (ADS)

Schmitt, R.; Pavim, A.

2009-06-01

The demand for achieving smaller and more flexible production series with a considerable diversity of products complicates the control of the manufacturing tasks, leading to big challenges for the quality assurance systems. The quality assurance strategy that is nowadays used for mass production is unable to cope with the inspection flexibility needed among automated small series production, because the measuring strategy is totally dependent on the fixed features of the few manufactured object variants and on process parameters that can be controlled/compensated during production time. The major challenge faced by a quality assurance system applied to small series production facilities is to guarantee the needed quality level already at the first run, and therefore, the quality assurance system has to adapt itself constantly to the new manufacturing conditions. The small series production culture requires a change of paradigms, because its strategies are totally different from mass production. This work discusses the tight inspection requirements of small series production and presents flexible metrology strategies based on optical sensor data fusion techniques, agent-based systems as well as cognitive and self-optimised systems for assuring the needed quality level of flexible small series. Examples of application scenarios are provided among the automated assembly of solid state lasers and the flexible inspection of automotive headlights.

Medicare and Medicaid programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; electronic reporting pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; revision to Quality Improvement Organization regulations. Final rule with comment period.

PubMed

2012-11-15

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We are continuing the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and revising the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes. The technical changes to the QIO regulations reflect CMS' commitment to the general principles of the President's Executive Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).

A conceptual persistent healthcare quality improvement process for software development management.

PubMed

Lin, Jen-Chiun; Su, Mei-Ju; Cheng, Po-Hsun; Weng, Yung-Chien; Chen, Sao-Jie; Lai, Jin-Shin; Lai, Feipei

2007-01-01

This paper illustrates a sustained conceptual service quality improvement process for the management of software development within a healthcare enterprise. Our proposed process is revised from Niland's healthcare quality information system (HQIS). This process includes functions to survey the satisfaction of system functions, describe the operation bylaws on-line, and provide on-demand training. To achieve these goals, we integrate five information systems in National Taiwan University Hospital, including healthcare information systems, health quality information system, requirement management system, executive information system, and digital learning system, to form a full Deming cycle. A preliminary user satisfaction survey showed that our outpatient information system scored an average of 71.31 in 2006.

MODIS. Volume 1: MODIS level 1A software baseline requirements

NASA Technical Reports Server (NTRS)

Masuoka, Edward; Fleig, Albert; Ardanuy, Philip; Goff, Thomas; Carpenter, Lloyd; Solomon, Carl; Storey, James

1994-01-01

This document describes the level 1A software requirements for the moderate resolution imaging spectroradiometer (MODIS) instrument. This includes internal and external requirements. Internal requirements include functional, operational, and data processing as well as performance, quality, safety, and security engineering requirements. External requirements include those imposed by data archive and distribution systems (DADS); scheduling, control, monitoring, and accounting (SCMA); product management (PM) system; MODIS log; and product generation system (PGS). Implementation constraints and requirements for adapting the software to the physical environment are also included.

Four Pillars for Improving the Quality of Safety-Critical Software-Reliant Systems

DTIC Science & Technology

2013-04-01

Studies of safety-critical software-reliant systems developed using the current practices of build-then-test show that requirements and architecture ... design defects make up approximately 70% of all defects, many system level related to operational quality attributes, and 80% of these defects are

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

The six critical attributes of the next generation of quality management software systems.

PubMed

Clark, Kathleen

2011-07-01

Driven by both the need to meet regulatory requirements and a genuine desire to drive improved quality, quality management systems encompassing standard operating procedure, corrective and preventative actions and related processes have existed for many years, both in paper and electronic form. The impact of quality management systems on 'actual' quality, however, is often reported as far less than desired. A quality management software system that moves beyond formal forms-driven processes to include a true closed loop design, manage disparate processes across the enterprise, provide support for collaborative processes and deliver insight into the overall state of control has the potential to close the gap between simply accomplishing regulatory compliance and delivering measurable improvements in quality and efficiency.

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...

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

Touati, Said; Chennai, Salim; Souli, Aissa

The increased requirements on supervision, control, and performance in modern power systems make power quality monitoring a common practise for utilities. Large databases are created and automatic processing of the data is required for fast and effective use of the available information. Aim of the work presented in this paper is the development of tools for analysis of monitoring power quality data and in particular measurements of voltage and currents in various level of electrical power distribution. The study is extended to evaluate the reliability of the electrical system in nuclear plant. Power Quality is a measure of how wellmore » a system supports reliable operation of its loads. A power disturbance or event can involve voltage, current, or frequency. Power disturbances can originate in consumer power systems, consumer loads, or the utility. The effect of power quality problems is the loss power supply leading to severe damage to equipments. So, we try to track and improve system reliability. The assessment can be focused on the study of impact of short circuits on the system, harmonics distortion, power factor improvement and effects of transient disturbances on the Electrical System during motor starting and power system fault conditions. We focus also on the review of the Electrical System design against the Nuclear Directorate Safety Assessment principles, including those extended during the last Fukushima nuclear accident. The simplified configuration of the required system can be extended from this simple scheme. To achieve these studies, we have used a demo ETAP power station software for several simulations. (authors)« less

A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

ERIC Educational Resources Information Center

Lee, Seon Ah

2010-01-01

The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

Policy Development of Quality Assurance: A Critical Perspective on Past and Future Issues.

ERIC Educational Resources Information Center

van der Westhuizen, L. J.

2000-01-01

Provides an overview of the initiatives and development of policies to establish a workable quality assurance system for institutions of higher education in South Africa in the last decade. Notes challenges such as the government's emphasis on programs of study and its requirement that quality assurance systems include institutional auditing,…

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2010 CFR

2010-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must quality control personnel do? 111.105..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must...

Liquid Rocket Booster (LRB) for the Space Transportation System (STS) systems study. Appendix G: LRB for the STS system study level 2 requirements, revision 1

NASA Technical Reports Server (NTRS)

1989-01-01

Requirements are presented for shuttle system definition; performance and design characteristics; shuttle vehicle end item performance and design characteristics; ground operations complex performance and design characteristics; operability and system design and construction standards; and quality control.

77 FR 40836 - Pennsylvania Regulatory Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

....302. Number, Location and Depth of Monitoring Points The water quality monitoring system shall accurately characterize groundwater and surface water flow and chemistry and flow systems on the site and... properties of coal ash beneficially used and water quality monitoring requirements. Pennsylvania is...

Atmospheric Boundary Layer Modeling for Combined Meteorology and Air Quality Systems

EPA Science Inventory

Atmospheric Eulerian grid models for mesoscale and larger applications require sub-grid models for turbulent vertical exchange processes, particularly within the Planetary Boundary Layer (PSL). In combined meteorology and air quality modeling systems consistent PSL modeling of wi...

48 CFR 8.711 - Quality complaints.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Quality complaints. 8.711 Section 8.711 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING REQUIRED SOURCES OF SUPPLIES AND SERVICES Acquisition From Nonprofit Agencies Employing People Who Are...

Information Management System for the California State Water Resources Control Board (SWRCB)

NASA Technical Reports Server (NTRS)

Heald, T. C.; Redmann, G. H.

1973-01-01

A study was made to establish the requirements for an integrated state-wide information management system for water quality control and water quality rights for the State of California. The data sources and end requirements were analyzed for the data collected and used by the numerous agencies, both State and Federal, as well as the nine Regional Boards under the jurisdiction of the State Board. The report details the data interfaces and outlines the system design. A program plan and statement of work for implementation of the project is included.

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…

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... experience, and the individual's potential to perform safely. Freedom from alcohol abuse and illegal drugs is.... Freedom from alcohol abuse and illegal drugs is required. (ii) Quality assurance. A system that... certificate are expected. Safety equipment is available in hangars, shops, etc., and is serviceable. Shipping...

Primary display latency criteria based on flying qualities and performance data

NASA Technical Reports Server (NTRS)

Funk, John D., Jr.; Beck, Corin P.; Johns, John B.

1993-01-01

With a pilots' increasing use of visual cue augmentation, much requiring extensive pre-processing, there is a need to establish criteria for new avionics/display design. The timeliness and synchronization of the augmented cues is vital to ensure the performance quality required for precision mission task elements (MTEs) where augmented cues are the primary source of information to the pilot. Processing delays incurred while transforming sensor-supplied flight information into visual cues are unavoidable. Relationships between maximum control system delays and associated flying qualities levels are documented in MIL-F-83300 and MIL-F-8785. While cues representing aircraft status may be just as vital to the pilot as prompt control response for operations in instrument meteorological conditions, presently, there are no specification requirements on avionics system latency. To produce data relating avionics system latency to degradations in flying qualities, the Navy conducted two simulation investigations. During the investigations, flying qualities and performance data were recorded as simulated avionics system latency was varied. Correlated results of the investigation indicates that there is a detrimental impact of latency on flying qualities. Analysis of these results and consideration of key factors influencing their application indicate that: (1) Task performance degrades and pilot workload increases as latency is increased. Inconsistency in task performance increases as latency increases. (2) Latency reduces the probability of achieving Level 1 handling qualities with avionics system latency as low as 70 ms. (3) The data suggest that the achievement of desired performance will be ensured only at display latency values below 120 ms. (4) These data also suggest that avoidance of inadequate performance will be ensured only at display latency values below 150 ms.

A Scenario-Based Process for Requirements Development: Application to Mission Operations Systems

NASA Technical Reports Server (NTRS)

Bindschadler, Duane L.; Boyles, Carole A.

2008-01-01

The notion of using operational scenarios as part of requirements development during mission formulation (Phases A & B) is widely accepted as good system engineering practice. In the context of developing a Mission Operations System (MOS), there are numerous practical challenges to translating that notion into the cost-effective development of a useful set of requirements. These challenges can include such issues as a lack of Project-level focus on operations issues, insufficient or improper flowdown of requirements, flowdown of immature or poor-quality requirements from Project level, and MOS resource constraints (personnel expertise and/or dollars). System engineering theory must be translated into a practice that provides enough structure and standards to serve as guidance, but that retains sufficient flexibility to be tailored to the needs and constraints of a particular MOS or Project. We describe a detailed, scenario-based process for requirements development. Identifying a set of attributes for high quality requirements, we show how the portions of the process address many of those attributes. We also find that the basic process steps are robust, and can be effective even in challenging Project environments.

Toward a Global Water Quality Observing and Forecasting System

EPA Science Inventory

The Group on Earth Observations (GEO) Coastal and Inland Water Quality Working Group held a Water Quality Summit at the World Meteorological Organization (WMO) in Geneva, Switzerland April 20 to 22, 2015. The goal was to define specific water quality component requirements and de...

Testing, Requirements, and Metrics

NASA Technical Reports Server (NTRS)

Rosenberg, Linda; Hyatt, Larry; Hammer, Theodore F.; Huffman, Lenore; Wilson, William

1998-01-01

The criticality of correct, complete, testable requirements is a fundamental tenet of software engineering. Also critical is complete requirements based testing of the final product. Modern tools for managing requirements allow new metrics to be used in support of both of these critical processes. Using these tools, potential problems with the quality of the requirements and the test plan can be identified early in the life cycle. Some of these quality factors include: ambiguous or incomplete requirements, poorly designed requirements databases, excessive or insufficient test cases, and incomplete linkage of tests to requirements. This paper discusses how metrics can be used to evaluate the quality of the requirements and test to avoid problems later. Requirements management and requirements based testing have always been critical in the implementation of high quality software systems. Recently, automated tools have become available to support requirements management. At NASA's Goddard Space Flight Center (GSFC), automated requirements management tools are being used on several large projects. The use of these tools opens the door to innovative uses of metrics in characterizing test plan quality and assessing overall testing risks. In support of these projects, the Software Assurance Technology Center (SATC) is working to develop and apply a metrics program that utilizes the information now available through the application of requirements management tools. Metrics based on this information provides real-time insight into the testing of requirements and these metrics assist the Project Quality Office in its testing oversight role. This paper discusses three facets of the SATC's efforts to evaluate the quality of the requirements and test plan early in the life cycle, thus preventing costly errors and time delays later.

Southwest University's Innovative No-Fee Teacher Education Internships

ERIC Educational Resources Information Center

Zhang, Huirong; Xiong, Jianjie; Song, Naiqing

2013-01-01

This article describes Southwest University's no-fee teacher education internship models in terms of their organization, content, requirements, and quality assurance. It further introduces the quality assurance system, which comprises building a teaching internship system, establishing internship sites, guiding teacher training, and processing…

48 CFR 8.710 - Quality of merchandise.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Quality of merchandise. 8.710 Section 8.710 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING REQUIRED SOURCES OF SUPPLIES AND SERVICES Acquisition From Nonprofit Agencies Employing People Who...

ANALYTICAL EQUATIONS OF STORAGE RESERVOIR WATER QUALITY

EPA Science Inventory

Distribution system water quality protection is an integral aspect of public water supply management. Effective regulatory compliance requires a thorough understanding of the transport and mixing processes in storage reservoirs and their impacts on effluent water quality. This ...

Quality, risk management and governance in mental health: an overview.

PubMed

Callaly, Tom; Arya, Dinesh; Minas, Harry

2005-03-01

To consider the origin, current emphasis and relevance of the concepts of quality, risk management and clinical governance in mental health. Increasingly, health service boards and management teams are required to give attention to clinical governance rather than corporate governance alone. Clinical governance is a unifying quality concept that aims to produce a structure and systems to assure and improve the quality of clinical services by promoting an integrated and organization-wide approach towards continuous quality improvement. Many psychiatrists will find the reduction in clinical autonomy, the need to consider the welfare of the whole population as well as the individual patient for whom they are responsible, and the requirement that they play a part in a complex systems approach to quality improvement to be a challenge. Avoiding or ignoring this challenge will potentially lead to conflict with modern management approaches and increased loss of influence on future developments in mental health services.

Study and Development of Mobile Tracingterminal Based on Gprs for Agriculturalproducts Quality Tracking

NASA Astrophysics Data System (ADS)

Liu, Shihong; Meng, Hong; Zheng, Huoguo; Wu, Jiangshou

Traceability system has become an important means for food safety management. Global food industry and many countries have paid increasing attention to the construction of food traceability system, but rarely referred to tracing terminal. According to the technical requirements of cereal and oil products quality safety tracing process, we design and develop a mobile tracing terminal based on GPRS for agricultural products quality tracking to facilitate quality supervisors and consumers to track and trace the quality of related agricultural products anytime ,anywhere.

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.

QUASAR: A Method for the Quality Assessment of Software-Intensive System Architectures

DTIC Science & Technology

2006-07-01

subsystem, the sole purpose of which is to achieve that quality. Thus, all of the requirements for a fire detec- tion and suppression subsystem are... monorail , or train tracks) along which an APM travels. 26 CMU/SEI-2006-HB-001 1. Safety Goal Claims a. Safety Factor Goals − System Is Safe...of 80 kilometers per hour.” c. Safety Subsystem Requirements − Smoke Detector Sensitivity The architecture of the automated taxi fire detection and

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.

Quality improvement and emerging global health priorities

PubMed Central

Mensah Abrampah, Nana; Syed, Shamsuzzoha Babar; Hirschhorn, Lisa R; Nambiar, Bejoy; Iqbal, Usman; Garcia-Elorrio, Ezequiel; Chattu, Vijay Kumar; Devnani, Mahesh; Kelley, Edward

2018-01-01

Abstract Quality improvement approaches can strengthen action on a range of global health priorities. Quality improvement efforts are uniquely placed to reorient care delivery systems towards integrated people-centred health services and strengthen health systems to achieve Universal Health Coverage (UHC). This article makes the case for addressing shortfalls of previous agendas by articulating the critical role of quality improvement in the Sustainable Development Goal era. Quality improvement can stimulate convergence between health security and health systems; address global health security priorities through participatory quality improvement approaches; and improve health outcomes at all levels of the health system. Entry points for action include the linkage with antimicrobial resistance and the contentious issue of the health of migrants. The work required includes focussed attention on the continuum of national quality policy formulation, implementation and learning; alongside strengthening the measurement-improvement linkage. Quality improvement plays a key role in strengthening health systems to achieve UHC. PMID:29873793

Taguchi Approach to Design Optimization for Quality and Cost: An Overview

NASA Technical Reports Server (NTRS)

Unal, Resit; Dean, Edwin B.

1990-01-01

Calibrations to existing cost of doing business in space indicate that to establish human presence on the Moon and Mars with the Space Exploration Initiative (SEI) will require resources, felt by many, to be more than the national budget can afford. In order for SEI to succeed, we must actually design and build space systems at lower cost this time, even with tremendous increases in quality and performance requirements, such as extremely high reliability. This implies that both government and industry must change the way they do business. Therefore, new philosophy and technology must be employed to design and produce reliable, high quality space systems at low cost. In recognizing the need to reduce cost and improve quality and productivity, Department of Defense (DoD) and National Aeronautics and Space Administration (NASA) have initiated Total Quality Management (TQM). TQM is a revolutionary management strategy in quality assurance and cost reduction. TQM requires complete management commitment, employee involvement, and use of statistical tools. The quality engineering methods of Dr. Taguchi, employing design of experiments (DOE), is one of the most important statistical tools of TQM for designing high quality systems at reduced cost. Taguchi methods provide an efficient and systematic way to optimize designs for performance, quality, and cost. Taguchi methods have been used successfully in Japan and the United States in designing reliable, high quality products at low cost in such areas as automobiles and consumer electronics. However, these methods are just beginning to see application in the aerospace industry. The purpose of this paper is to present an overview of the Taguchi methods for improving quality and reducing cost, describe the current state of applications and its role in identifying cost sensitive design parameters.

21 CFR 820.25 - Personnel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Personnel. 820.25 Section 820.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Quality System Requirements § 820.25 Personnel. (a) General. Each manufacturer...

Assessment of non-destructive testing technologies for quality control/quality assurance of asphalt mixtures : [tech transfer summary].

DOT National Transportation Integrated Search

2015-02-01

Evaluation of the actual performance (quality) of pavements requires : in situ nondestructive testing (NDT) techniques that can accurately : measure the most critical, objective, and sensitive properties of : pavement systems.

48 CFR 2936.516 - Quality surveys.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Quality surveys. 2936.516... REQUIREMENTS CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Contract Clauses 2936.516 Quality surveys. The HCA... original and final surveys as prescribed in FAR 36.516. ...

48 CFR 2936.516 - Quality surveys.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Quality surveys. 2936.516... REQUIREMENTS CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Contract Clauses 2936.516 Quality surveys. The HCA... original and final surveys as prescribed in FAR 36.516. ...

48 CFR 2936.516 - Quality surveys.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Quality surveys. 2936.516... REQUIREMENTS CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Contract Clauses 2936.516 Quality surveys. The HCA... original and final surveys as prescribed in FAR 36.516. ...

48 CFR 2936.516 - Quality surveys.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Quality surveys. 2936.516... REQUIREMENTS CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Contract Clauses 2936.516 Quality surveys. The HCA... original and final surveys as prescribed in FAR 36.516. ...

48 CFR 2936.516 - Quality surveys.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Quality surveys. 2936.516... REQUIREMENTS CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS Contract Clauses 2936.516 Quality surveys. The HCA... original and final surveys as prescribed in FAR 36.516. ...

Producing Quality Water for Industrial Use.

ERIC Educational Resources Information Center

Schaezler, Donald J.

1978-01-01

This article discusses the quality of water demanded by industrial plants and the techniques which are currently employed to achieve them. Both quality and quantity requirements are considered including total plant operation, physical and chemical operating controls, and systems monitoring. (CS)

Medicare and Medicaid programs: hospital outpatient prospective payment; ambulatory surgical center payment; hospital value-based purchasing program; physician self-referral; and patient notification requirements in provider agreements. Final rule with comment period.

PubMed

2011-11-30

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) for CY 2012 to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other ratesetting information for the CY 2012 ASC payment system. We are revising the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, adding new requirements for ASC Quality Reporting System, and making additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are allowing eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. Finally, we are making changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.

Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

PubMed Central

2015-01-01

Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

[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.

48 CFR 1646.301 - Contractor inspection requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Contractor inspection requirements. 1646.301 Section 1646.301 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract...

48 CFR 1646.301 - Contractor inspection requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Contractor inspection requirements. 1646.301 Section 1646.301 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract...

48 CFR 1646.301 - Contractor inspection requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Contractor inspection requirements. 1646.301 Section 1646.301 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract...

48 CFR 1646.301 - Contractor inspection requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Contractor inspection requirements. 1646.301 Section 1646.301 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2012 CFR

2012-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2011 CFR

2011-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

42 CFR 412.140 - Participation, data submission, and validation requirements under the Hospital Inpatient Quality...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Participation, data submission, and validation... Payment Systems § 412.140 Participation, data submission, and validation requirements under the Hospital....org, before it begins to report data; (2) Identify and register a QualityNet Administrator as part of...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

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.

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.

Post LANDSAT D Advanced Concept Evaluation (PLACE). [with emphasis on mission planning, technological forecasting, and user requirements

NASA Technical Reports Server (NTRS)

1977-01-01

An outline is given of the mission objectives and requirements, system elements, system concepts, technology requirements and forecasting, and priority analysis for LANDSAT D. User requirements and mission analysis and technological forecasting are emphasized. Mission areas considered include agriculture, range management, forestry, geology, land use, water resources, environmental quality, and disaster assessment.

Development and Application of the Key Technologies for the Quality Control and Inspection of National Geographical Conditions Survey Products

NASA Astrophysics Data System (ADS)

Zhao, Y.; Zhang, L.; Ma, W.; Zhang, P.; Zhao, T.

2018-04-01

The First National Geographical Condition Survey is a predecessor task to dynamically master basic situations of the nature, ecology and human activities on the earth's surface and it is the brand-new mapping geographic information engineering. In order to ensure comprehensive, real and accurate survey results and achieve the quality management target which the qualified rate is 100 % and the yield is more than 80 %, it is necessary to carry out the quality control and result inspection for national geographical conditions survey on a national scale. To ensure that achievement quality meets quality target requirements, this paper develops the key technology method of "five-in-one" quality control that is constituted by "quality control system of national geographical condition survey, quality inspection technology system, quality evaluation system, quality inspection information management system and national linked quality control institutions" by aiming at large scale, wide coverage range, more undertaking units, more management levels, technical updating, more production process and obvious regional differences in the national geographical condition survey and combining with novel achievement manifestation, complicated dependency, more special reference data, and large data size. This project fully considering the domestic and foreign related research results and production practice experience, combined with the technology development and the needs of the production, it stipulates the inspection methods and technical requirements of each stage in the quality inspection of the geographical condition survey results, and extends the traditional inspection and acceptance technology, and solves the key technologies that are badly needed in the first national geographic survey.

76 FR 57646 - Final Withdrawal of Certain Federal Aquatic Life Water Quality Criteria Applicable to Wisconsin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... limits in National Pollutant Discharge Elimination System (NPDES) permits, and may affect Clean Water Act... the final Water Quality Guidance for the Great Lakes System (Guidance), required by CWA Section 118(c... waters of the Great Lakes System in Wisconsin designated as Warm Water Sportfish and Warm Water Forage...

Risk of Performance Decrement and Crew Illness Due to an Inadequate Food System

NASA Technical Reports Server (NTRS)

Douglas, Grace L.; Cooper, Maya; Bermudez-Aguirre, Daniela; Sirmons, Takiyah

2016-01-01

NASA is preparing for long duration manned missions beyond low-Earth orbit that will be challenged in several ways, including long-term exposure to the space environment, impacts to crew physiological and psychological health, limited resources, and no resupply. The food system is one of the most significant daily factors that can be altered to improve human health, and performance during space exploration. Therefore, the paramount importance of determining the methods, technologies, and requirements to provide a safe, nutritious, and acceptable food system that promotes crew health and performance cannot be underestimated. The processed and prepackaged food system is the main source of nutrition to the crew, therefore significant losses in nutrition, either through degradation of nutrients during processing and storage or inadequate food intake due to low acceptability, variety, or usability, may significantly compromise the crew's health and performance. Shelf life studies indicate that key nutrients and quality factors in many space foods degrade to concerning levels within three years, suggesting that food system will not meet the nutrition and acceptability requirements of a long duration mission beyond low-Earth orbit. Likewise, mass and volume evaluations indicate that the current food system is a significant resource burden. Alternative provisioning strategies, such as inclusion of bioregenerative foods, are challenged with resource requirements, and food safety and scarcity concerns. Ensuring provisioning of an adequate food system relies not only upon determining technologies, and requirements for nutrition, quality, and safety, but upon establishing a food system that will support nutritional adequacy, even with individual crew preference and self-selection. In short, the space food system is challenged to maintain safety, nutrition, and acceptability for all phases of an exploration mission within resource constraints. This document presents the evidence for the Risk of Performance Decrement and Crew Illness Due to an Inadequate Food System and the gaps in relation to exploration, as identified by the NASA Human Research Program (HRP). The research reviewed here indicates strategies to establish methods, technologies, and requirements that increase food stability, support adequate nutrition, quality, and variety, enable supplementation with grow-pick-and-eat salad crops, ensure safety, and reduce resource use. Obtaining the evidence to establish an adequate food system is essential, as the resources allocated to the food system may be defined based on the data relating nutritional stability and food quality requirements to crew performance and health.

40 CFR 35.915 - State priority system and project priorty list.

Code of Federal Regulations, 2010 CFR

2010-07-01

... State priority system and list must be designed to achieve optimum water quality management consistent... water quality management (WQM) plans. The State shall hold a public hearing before submission of the... also sets forth the administrative, management, and public participation procedures required to develop...

Assessment of runoff water quality for an integrated best-management practice system in an agricultural watershed

USDA-ARS?s Scientific Manuscript database

To better understand, implement and integrate best management practices (BMPs) in agricultural watersheds, critical information on their effectiveness is required. A representative agricultural watershed, Beasley Lake, was used to compare runoff water quality draining through an integrated system of...

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

Santos, Rick; van Dam, Jeroen

The objective of the test was to obtain a baseline characterization of the mechanical loads of the DOE 1.5 wind turbine located at NREL. The test was conducted in accordance with the International Electrotechnical Commission (IEC) Technical Specification, IEC 61400-13 Wind Turbine Generator Systems – Part 13: Measurement of mechanical loads; First Edition 2001-06 [1]. The National Wind Technology Center (NWTC) at NREL conducted this test in accordance with its quality system procedures so that the final test report meets the full requirements of its accreditation by the American Association for Laboratory Accreditation (A2LA). NREL’s quality system requires that allmore » applicable requirements specified by A2LA and International Standards Organization/IEC 17025 be met or to note any exceptions in the test report.« less

Honing the accuracy of extreme-ultraviolet optical system testing: at-wavelength and visible-light measurements of the ETS Set-2 projection optic

NASA Astrophysics Data System (ADS)

Goldberg, Kenneth A.; Naulleau, Patrick P.; Bokor, Jeffrey; Chapman, Henry N.

2002-07-01

As the quality of optical systems for extreme ultraviolet lithography improves, high-accuracy wavefront metrology for alignment and qualification becomes ever more important. To enable the development of diffraction-limited EUV projection optics, visible-light and EUV interferometries must work in close collaboration. We present a detailed comparison of EUV and visible-light wavefront measurements performed across the field of view of a lithographic-quality EUV projection optical system designed for use in the Engineering Test Stand developed by the Virtual National Laboratory and the EUV Limited Liability Company. The comparisons reveal that the present level of RMS agreement lies in the 0.3-0.4-nm range. Astigmatism is the most significant aberration component for the alignment of this optical system; it is also the dominant term in the discrepancy, and the aberration with the highest measurement uncertainty. With EUV optical systems requiring total wavefront quality in the (lambda) EUV/50 range, and even higher surface-figure quality for the individual mirror elements, improved accuracy through future comparisons, and additional studies, are required.

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.

Auditing of suppliers as the requirement of quality management systems in construction

NASA Astrophysics Data System (ADS)

Harasymiuk, Jolanta; Barski, Janusz

2017-07-01

The choice of a supplier of construction materials can be important factor of increase or reduction of building works costs. Construction materials present from 40 for 70% of investment task depending on kind of works being provided for realization. There is necessity of estimate of suppliers from the point of view of effectiveness of construction undertaking and necessity from the point of view of conformity of taken operation by executives of construction job and objects within the confines of systems of managements quality being initiated in their organizations. The estimate of suppliers of construction materials and subexecutives of special works is formal requirement in quality management systems, which meets the requirements of the ISO 9001 standard. The aim of this paper is to show possibilities of making use of anaudit for estimate of credibility and reliability of the supplier of construction materials. The article describes kinds of audits, that were carried in quality management systems, with particular taking into consideration audits called as second-site. One characterizes the estimate criterions of qualitative ability and method of choice of the supplier of construction materials. The paper shows also propositions of exemplary questions, that would be estimated in audit process, the way of conducting of this estimate and conditionality of estimate.

Mine Winder Drives in Integrated Copper Complex

NASA Astrophysics Data System (ADS)

Dey, Pranab Kumar

2018-04-01

This paper describes various features required to be evaluated before selecting mine winder drives. In handling such project, the selection of proper equipments is necessary at the initial design stage of planning and how the electrical system design considers all aspects to protect the grid from unwarranted influence of the connected loads and minimize the generation of harmonics due to network configurations adopted to keep it within the stipulated value dictated by the supply authorities has been discussed. The design should cover all aspects to provide quality power with effective braking system required as per the mining statute for operational safety. It also emphasizes on the requirement of quality maintenance.

40 CFR 63.9808 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2010 CFR

2010-07-01

... times, you must maintain your monitoring systems including, but not limited to, maintaining necessary parts for routine repairs of the monitoring equipment. (c) Except for, as applicable, monitoring system malfunctions, associated repairs, and required quality assurance or quality control activities, you must...

40 CFR 63.9808 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2014 CFR

2014-07-01

... times, you must maintain your monitoring systems including, but not limited to, maintaining necessary parts for routine repairs of the monitoring equipment. (c) Except for, as applicable, monitoring system malfunctions, associated repairs, and required quality assurance or quality control activities, you must...

40 CFR 63.9808 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

... times, you must maintain your monitoring systems including, but not limited to, maintaining necessary parts for routine repairs of the monitoring equipment. (c) Except for, as applicable, monitoring system malfunctions, associated repairs, and required quality assurance or quality control activities, you must...

40 CFR 63.9808 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2011 CFR

2011-07-01

... times, you must maintain your monitoring systems including, but not limited to, maintaining necessary parts for routine repairs of the monitoring equipment. (c) Except for, as applicable, monitoring system malfunctions, associated repairs, and required quality assurance or quality control activities, you must...

40 CFR 63.9808 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2013 CFR

2013-07-01

... times, you must maintain your monitoring systems including, but not limited to, maintaining necessary parts for routine repairs of the monitoring equipment. (c) Except for, as applicable, monitoring system malfunctions, associated repairs, and required quality assurance or quality control activities, you must...

40 CFR 141.87 - Monitoring requirements for water quality parameters.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... (c) Monitoring after installation of corrosion control. Any large system which installs optimal corrosion control treatment pursuant to § 141.81(d)(4) shall measure the water quality parameters at the...)(i). Any small or medium-size system which installs optimal corrosion control treatment shall conduct...

40 CFR 141.87 - Monitoring requirements for water quality parameters.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... (c) Monitoring after installation of corrosion control. Any large system which installs optimal corrosion control treatment pursuant to § 141.81(d)(4) shall measure the water quality parameters at the...)(i). Any small or medium-size system which installs optimal corrosion control treatment shall conduct...

40 CFR 141.87 - Monitoring requirements for water quality parameters.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... (c) Monitoring after installation of corrosion control. Any large system which installs optimal corrosion control treatment pursuant to § 141.81(d)(4) shall measure the water quality parameters at the...)(i). Any small or medium-size system which installs optimal corrosion control treatment shall conduct...

40 CFR 141.87 - Monitoring requirements for water quality parameters.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... (c) Monitoring after installation of corrosion control. Any large system which installs optimal corrosion control treatment pursuant to § 141.81(d)(4) shall measure the water quality parameters at the...)(i). Any small or medium-size system which installs optimal corrosion control treatment shall conduct...

40 CFR 141.87 - Monitoring requirements for water quality parameters.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... (c) Monitoring after installation of corrosion control. Any large system which installs optimal corrosion control treatment pursuant to § 141.81(d)(4) shall measure the water quality parameters at the...)(i). Any small or medium-size system which installs optimal corrosion control treatment shall conduct...

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...

Models and Methods of Aggregating Linguistic Information in Multi-criteria Hierarchical Quality Assessment Systems

NASA Astrophysics Data System (ADS)

Azarnova, T. V.; Titova, I. A.; Barkalov, S. A.

2018-03-01

The article presents an algorithm for obtaining an integral assessment of the quality of an organization from the perspective of customers, based on the method of aggregating linguistic information on a multilevel hierarchical system of quality assessment. The algorithm is of a constructive nature, it provides not only the possibility of obtaining an integral evaluation, but also the development of a quality improvement strategy based on the method of linguistic decomposition, which forms the minimum set of areas of work with clients whose quality change will allow obtaining the required level of integrated quality assessment.

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

2005 8th Annual Systems Engineering Conference. Volume 4, Thursday

DTIC Science & Technology

2005-10-27

requirements, allocation , and utilization statistics Operations Decisions Acquisition Decisions Resource Management — Integrated Requirements/ Allocation ...Quality Improvement Consultants, Inc. “Automated Software Testing Increases Test Quality and Coverage Resulting in Improved Software Reliability.”, Mr...Steven Ligon, SAIC The Return of Discipline, Ms. Jacqueline Townsend, Air Force Materiel Command Track 4 - Net Centric Operations: Testing Net-Centric

National Pollutant Discharge Elimination System (NPDES) Permit Application Requirement for Storm Water Discharges

DTIC Science & Technology

1991-05-01

schedule for construction, upgrading or operation of wastewater treatment facilities or any other environmental programs, which may effect storm water quality of...if the storm water quality may be similar. c. Two sets of samples are required to be collected: (1) A grab during the first 30 minutes of the rainfall

[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.

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

In-situ quality monitoring during laser brazing

NASA Astrophysics Data System (ADS)

Ungers, Michael; Fecker, Daniel; Frank, Sascha; Donst, Dmitri; Märgner, Volker; Abels, Peter; Kaierle, Stefan

Laser brazing of zinc coated steel is a widely established manufacturing process in the automotive sector, where high quality requirements must be fulfilled. The strength, impermeablitiy and surface appearance of the joint are particularly important for judging its quality. The development of an on-line quality control system is highly desired by the industry. This paper presents recent works on the development of such a system, which consists of two cameras operating in different spectral ranges. For the evaluation of the system, seam imperfections are created artificially during experiments. Finally image processing algorithms for monitoring process parameters based the captured images are presented.

Coherent scattering noise reduction method with wavelength diversity detection for holographic data storage system

NASA Astrophysics Data System (ADS)

Nakamura, Yusuke; Hoshizawa, Taku; Takashima, Yuzuru

2017-09-01

A new method, wavelength diversity detection (WDD), for improving signal quality is proposed and its effectiveness is numerically confirmed. We consider that WDD is especially effective for high-capacity systems having low hologram diffraction efficiencies. In such systems, the signal quality is primarily limited by coherent scattering noise; thus, effective improvement of the signal quality under a scattering-limited system is of great interest. WDD utilizes a new degree of freedom, the spectrum width, and scattering by molecules to improve the signal quality of the system. We found that WDD improves the quality by counterbalancing the degradation of the quality due to Bragg mismatch. With WDD, a higher-scattering-coefficient medium can improve the quality. The result provides an interesting insight into the requirements for material characteristics, especially for a large-M/# material. In general, a larger-M/# material contains more molecules; thus, the system is subject to more scattering, which actually improves the quality with WDD. We propose a pathway for a future holographic data storage system (HDSS) using WDD, which can record a larger amount of data than a conventional HDSS.

Are university rankings useful to improve research? A systematic review.

PubMed

Vernon, Marlo M; Balas, E Andrew; Momani, Shaher

2018-01-01

Concerns about reproducibility and impact of research urge improvement initiatives. Current university ranking systems evaluate and compare universities on measures of academic and research performance. Although often useful for marketing purposes, the value of ranking systems when examining quality and outcomes is unclear. The purpose of this study was to evaluate usefulness of ranking systems and identify opportunities to support research quality and performance improvement. A systematic review of university ranking systems was conducted to investigate research performance and academic quality measures. Eligibility requirements included: inclusion of at least 100 doctoral granting institutions, be currently produced on an ongoing basis and include both global and US universities, publish rank calculation methodology in English and independently calculate ranks. Ranking systems must also include some measures of research outcomes. Indicators were abstracted and contrasted with basic quality improvement requirements. Exploration of aggregation methods, validity of research and academic quality indicators, and suitability for quality improvement within ranking systems were also conducted. A total of 24 ranking systems were identified and 13 eligible ranking systems were evaluated. Six of the 13 rankings are 100% focused on research performance. For those reporting weighting, 76% of the total ranks are attributed to research indicators, with 24% attributed to academic or teaching quality. Seven systems rely on reputation surveys and/or faculty and alumni awards. Rankings influence academic choice yet research performance measures are the most weighted indicators. There are no generally accepted academic quality indicators in ranking systems. No single ranking system provides a comprehensive evaluation of research and academic quality. Utilizing a combined approach of the Leiden, Thomson Reuters Most Innovative Universities, and the SCImago ranking systems may provide institutions with a more effective feedback for research improvement. Rankings which extensively rely on subjective reputation and "luxury" indicators, such as award winning faculty or alumni who are high ranking executives, are not well suited for academic or research performance improvement initiatives. Future efforts should better explore measurement of the university research performance through comprehensive and standardized indicators. This paper could serve as a general literature citation when one or more of university ranking systems are used in efforts to improve academic prominence and research performance.

Data Requirement (DR) MA-03: Payload missions integration. [Spacelab payloads

NASA Technical Reports Server (NTRS)

1985-01-01

Project management and payload integration requirements definition activities are reported. Mission peculiar equipment; systems integration; ground operations analysis and requirement definition; safety and quality assurance; and support systems development are examined for payloads planned for the following missions: EOM-1; SL-2; Sl-3 Astro-1; MSL-2; EASE/ACCESS; MPESS; and the middeck ADSF flight.

76 FR 42169 - Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-18

...This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. These proposed changes would be applicable to services furnished on or after January 1, 2012. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we set forth the proposed relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other proposed ratesetting information for the CY 2012 ASC payment system. These proposed changes would be applicable to services furnished on or after January 1, 2012. We are proposing to revise the requirements for the Hospital Outpatient Quality Reporting (IQR) Program, add new requirements for ASC Quality Reporting System, and make additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are proposing to allow eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. In addition, we are proposing to make changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.

Production and quality assurance automation in the Goddard Space Flight Center Flight Dynamics Facility

NASA Technical Reports Server (NTRS)

Chapman, K. B.; Cox, C. M.; Thomas, C. W.; Cuevas, O. O.; Beckman, R. M.

1994-01-01

The Flight Dynamics Facility (FDF) at the NASA Goddard Space Flight Center (GSFC) generates numerous products for NASA-supported spacecraft, including the Tracking and Data Relay Satellites (TDRS's), the Hubble Space Telescope (HST), the Extreme Ultraviolet Explorer (EUVE), and the space shuttle. These products include orbit determination data, acquisition data, event scheduling data, and attitude data. In most cases, product generation involves repetitive execution of many programs. The increasing number of missions supported by the FDF has necessitated the use of automated systems to schedule, execute, and quality assure these products. This automation allows the delivery of accurate products in a timely and cost-efficient manner. To be effective, these systems must automate as many repetitive operations as possible and must be flexible enough to meet changing support requirements. The FDF Orbit Determination Task (ODT) has implemented several systems that automate product generation and quality assurance (QA). These systems include the Orbit Production Automation System (OPAS), the New Enhanced Operations Log (NEOLOG), and the Quality Assurance Automation Software (QA Tool). Implementation of these systems has resulted in a significant reduction in required manpower, elimination of shift work and most weekend support, and improved support quality, while incurring minimal development cost. This paper will present an overview of the concepts used and experiences gained from the implementation of these automation systems.

Design of a practical model-observer-based image quality assessment method for x-ray computed tomography imaging systems

PubMed Central

Tseng, Hsin-Wu; Fan, Jiahua; Kupinski, Matthew A.

2016-01-01

Abstract. The use of a channelization mechanism on model observers not only makes mimicking human visual behavior possible, but also reduces the amount of image data needed to estimate the model observer parameters. The channelized Hotelling observer (CHO) and channelized scanning linear observer (CSLO) have recently been used to assess CT image quality for detection tasks and combined detection/estimation tasks, respectively. Although the use of channels substantially reduces the amount of data required to compute image quality, the number of scans required for CT imaging is still not practical for routine use. It is our desire to further reduce the number of scans required to make CHO or CSLO an image quality tool for routine and frequent system validations and evaluations. This work explores different data-reduction schemes and designs an approach that requires only a few CT scans. Three different kinds of approaches are included in this study: a conventional CHO/CSLO technique with a large sample size, a conventional CHO/CSLO technique with fewer samples, and an approach that we will show requires fewer samples to mimic conventional performance with a large sample size. The mean value and standard deviation of areas under ROC/EROC curve were estimated using the well-validated shuffle approach. The results indicate that an 80% data reduction can be achieved without loss of accuracy. This substantial data reduction is a step toward a practical tool for routine-task-based QA/QC CT system assessment. PMID:27493982

Portuguese food composition database quality management system.

PubMed

Oliveira, L M; Castanheira, I P; Dantas, M A; Porto, A A; Calhau, M A

2010-11-01

The harmonisation of food composition databases (FCDB) has been a recognised need among users, producers and stakeholders of food composition data (FCD). To reach harmonisation of FCDBs among the national compiler partners, the European Food Information Resource (EuroFIR) Network of Excellence set up a series of guidelines and quality requirements, together with recommendations to implement quality management systems (QMS) in FCDBs. The Portuguese National Institute of Health (INSA) is the national FCDB compiler in Portugal and is also a EuroFIR partner. INSA's QMS complies with ISO/IEC (International Organization for Standardisation/International Electrotechnical Commission) 17025 requirements. The purpose of this work is to report on the strategy used and progress made for extending INSA's QMS to the Portuguese FCDB in alignment with EuroFIR guidelines. A stepwise approach was used to extend INSA's QMS to the Portuguese FCDB. The approach included selection of reference standards and guides and the collection of relevant quality documents directly or indirectly related to the compilation process; selection of the adequate quality requirements; assessment of adequacy and level of requirement implementation in the current INSA's QMS; implementation of the selected requirements; and EuroFIR's preassessment 'pilot' auditing. The strategy used to design and implement the extension of INSA's QMS to the Portuguese FCDB is reported in this paper. The QMS elements have been established by consensus. ISO/IEC 17025 management requirements (except 4.5) and 5.2 technical requirements, as well as all EuroFIR requirements (including technical guidelines, FCD compilation flowchart and standard operating procedures), have been selected for implementation. The results indicate that the quality management requirements of ISO/IEC 17025 in place in INSA fit the needs for document control, audits, contract review, non-conformity work and corrective actions, and users' (customers') comments, complaints and satisfaction, with minor adaptation. Implementation of the FCDB QMS proved to be a way of reducing the subjectivity of the compilation process and fully documenting it, and also facilitates training of new compilers. Furthermore, it has strengthened cooperation and trust among FCDB actors, as all of them were called to be involved in the process. On the basis of our practical results, we can conclude that ISO/IEC 17025 management requirements are an adequate reference for the implementation of INSA's FCDB QMS with the advantages of being well known to all members of staff and also being a common quality language among laboratories producing FCD. Combining quality systems and food composition activities endows the FCDB compilation process with flexibility, consistency and transparency, and facilitates its monitoring and assessment, providing the basis for strengthening confidence among users, data producers and compilers.

Quality Assurance and Quality Control, Part 2.

PubMed

Akers, Michael J

2015-01-01

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

Small and big quality in health care.

PubMed

Lillrank, Paul Martin

2015-01-01

The purpose of this paper is to clarify healthcare quality's ontological and epistemological foundations; and examine how these lead to different measurements and technologies. Conceptual analysis. Small quality denotes conformance to ex ante requirements. Big quality includes product and service design, based on customer requirements and expectations. Healthcare quality can be divided into three areas: clinical decision making; patient safety; and patient experience, each with distinct measurement and improvement technologies. The conceptual model is expected to bring clarity to constructing specific definitions, measures, objectives and technologies for improving healthcare. This paper claims that before healthcare quality can be defined, measured and integrated into systems, it needs to be clearly separated into ontologically and epistemologically different parts.

[Wireless digital radiography detectors in the emergency area: an efficacious solution].

PubMed

Garrido Blázquez, M; Agulla Otero, M; Rodríguez Recio, F J; Torres Cabrera, R; Hernando González, I

2013-01-01

To evaluate the implementation of a flat panel digital radiolography (DR) system with WiFi technology in an emergency radiology area in which a computed radiography (CR) system was previously used. We analyzed aspects related to image quality, radiation dose, workflow, and ergonomics. We analyzed the results obtained with the CR and WiFi DR systems related with the quality of images analyzed in images obtained using a phantom and after radiologists' evaluation of radiological images obtained in real patients. We also analyzed the time required for image acquisition and the workflow with the two technological systems. Finally, we analyzed the data related to the dose of radiation in patients before and after the implementation of the new equipment. Image quality improved in both the tests carried out with a phantom and in radiological images obtained in patients, which increased from 3 to 4.5 on a 5-point scale. The average time required for image acquisition decreased by 25 seconds per image. The flat panel required less radiation to be delivered in practically all the techniques carried out using automatic dosimetry, although statistically significant differences were found in only some of the techniques (chest, thoracic spine, and lumbar spine). Implementing the WiFi DR system has brought benefits. Image quality has improved and the dose of radiation to patients has decreased. The new system also has advantages in terms of functionality, ergonomics, and performance. Copyright © 2011 SERAM. Published by Elsevier Espana. All rights reserved.

Strengthening the regulatory system through the implementation and use of a quality management system.

PubMed

Eisner, Reinhold; Patel, Rakeshkumar

2017-04-20

Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada's Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

15 CFR Appendix A to Subpart C of... - Certification Application Templates

Code of Federal Regulations, 2010 CFR

2010-01-01

... as to the purpose of its products as described in this requirement. (15) Quality management system... certification of compliance with an equivalent program of quality management that covers the processes described... Trade (Continued) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY...

Modelling health care processes for eliciting user requirements: a way to link a quality paradigm and clinical information system design.

PubMed

Staccini, P; Joubert, M; Quaranta, J F; Fieschi, D; Fieschi, M

2000-01-01

Hospital information systems have to support quality improvement objectives. The design issues of health care information system can be classified into three categories: 1) time-oriented and event-labelled storage of patient data; 2) contextual support of decision-making; 3) capabilities for modular upgrading. The elicitation of the requirements has to meet users' needs in relation to both the quality (efficacy, safety) and the monitoring of all health care activities (traceability). Information analysts need methods to conceptualize clinical information systems that provide actors with individual benefits and guide behavioural changes. A methodology is proposed to elicit and structure users' requirements using a process-oriented analysis, and it is applied to the field of blood transfusion. An object-oriented data model of a process has been defined in order to identify its main components: activity, sub-process, resources, constrains, guidelines, parameters and indicators. Although some aspects of activity, such as "where", "what else", and "why" are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for this approach to be generalised within the organisation, for the processes to be interrelated, and for their characteristics to be shared.

Automated processing of whole blood units: operational value and in vitro quality of final blood components

PubMed Central

Jurado, Marisa; Algora, Manuel; Garcia-Sanchez, Félix; Vico, Santiago; Rodriguez, Eva; Perez, Sonia; Barbolla, Luz

2012-01-01

Background The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. Materials and methods Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. Results The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. Discussion These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement. PMID:22044958

Automated processing of whole blood units: operational value and in vitro quality of final blood components.

PubMed

Jurado, Marisa; Algora, Manuel; Garcia-Sanchez, Félix; Vico, Santiago; Rodriguez, Eva; Perez, Sonia; Barbolla, Luz

2012-01-01

The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement.

Spatial Allocator for air quality modeling

EPA Pesticide Factsheets

The Spatial Allocator is a set of tools that helps users manipulate and generate data files related to emissions and air quality modeling without requiring the use of a commercial Geographic Information System.

Objective assessment of MPEG-2 video quality

NASA Astrophysics Data System (ADS)

Gastaldo, Paolo; Zunino, Rodolfo; Rovetta, Stefano

2002-07-01

The increasing use of video compression standards in broadcasting television systems has required, in recent years, the development of video quality measurements that take into account artifacts specifically caused by digital compression techniques. In this paper we present a methodology for the objective quality assessment of MPEG video streams by using circular back-propagation feedforward neural networks. Mapping neural networks can render nonlinear relationships between objective features and subjective judgments, thus avoiding any simplifying assumption on the complexity of the model. The neural network processes an instantaneous set of input values, and yields an associated estimate of perceived quality. Therefore, the neural-network approach turns objective quality assessment into adaptive modeling of subjective perception. The objective features used for the estimate are chosen according to the assessed relevance to perceived quality and are continuously extracted in real time from compressed video streams. The overall system mimics perception but does not require any analytical model of the underlying physical phenomenon. The capability to process compressed video streams represents an important advantage over existing approaches, like avoiding the stream-decoding process greatly enhances real-time performance. Experimental results confirm that the system provides satisfactory, continuous-time approximations for actual scoring curves concerning real test videos.

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.

Quality management system in the CIEMAT Radiation Dosimetry Service.

PubMed

Martín, R; Navarro, T; Romero, A M; López, M A

2011-03-01

This paper describes the activities realised by the CIEMAT Radiation Dosimetry Service (SDR) for the implementation of a quality management system (QMS) in order to achieve compliance with the requirements of ISO/IEC 17025 and to apply for the accreditation for testing measurements of radiation dose. SDR has decided the accreditation of the service as a whole and not for each of its component laboratories. This makes it necessary to design a QMS common to all, thus ensuring alignment and compliance with standard requirements, and simplifying routine works as possible.

40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... and the run average); (B) The raw data and results for all required pre-test, post-test, pre-run and...-day calibration error tests, all daily system integrity checks (Hg monitors, only), and all off-line calibration demonstrations, including any follow-up tests after corrective action: (i) Component-system...

42 CFR 425.504 - Incorporating reporting requirements related to the Physician Quality Reporting System.

Code of Federal Regulations, 2012 CFR

2012-10-01

... under their ACO participant TIN as a group practice under the Physician Quality Reporting System Group... participant TIN, on behalf of its ACO supplier/provider participants who are eligible professionals, will... Physician Fee Schedule for that TIN. (4) ACO participant TINs and individual ACO providers/suppliers who are...

42 CFR 425.504 - Incorporating reporting requirements related to the Physician Quality Reporting System.

Code of Federal Regulations, 2013 CFR

2013-10-01

... under their ACO participant TIN as a group practice under the Physician Quality Reporting System Group... participant TIN, on behalf of its ACO supplier/provider participants who are eligible professionals, will... Physician Fee Schedule for that TIN. (4) ACO participant TINs and individual ACO providers/suppliers who are...

The Systemic Vision of the Educational Learning

ERIC Educational Resources Information Center

Lima, Nilton Cesar; Penedo, Antonio Sergio Torres; de Oliveira, Marcio Mattos Borges; de Oliveira, Sonia Valle Walter Borges; Queiroz, Jamerson Viegas

2012-01-01

As the sophistication of technology is increasing, also increased the demand for quality in education. The expectation for quality has promoted broad range of products and systems, including in education. These factors include the increased diversity in the student body, which requires greater emphasis that allows a simple and dynamic model in the…

Technologies of Student Testing for Learning Quality Evaluation in the System of Higher Education

ERIC Educational Resources Information Center

Bayukova, Nadezhda Olegovna; Kareva, Ludmila Alexandrovna; Rudometova, Liliya Tarasovna; Shlangman, Marina Konstantinovna; Yarantseva, Natalia Vladislavovna

2015-01-01

The paper deals with technology of students' achievement in the area of educational activities, methods, techniques, forms and conditions of monitoring knowledge quality in accordance with the requirements of Russian higher education system modernization. The authors propose methodic techniques of students' training for testing based on innovative…

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.

Exploring Nontraditional Participation as an Approach to Make Water Quality Trading Markets More Effective

EPA Science Inventory

Water quality trading (WQT) under the Clean Water Act is a compliance option for water quality based effluent limitations in a National Pollutant Discharge Elimination System (NPDES) permit (i.e., the requirements for discharging, monitoring, and reporting). States that have enac...

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...

40 CFR 63.11221 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

... malfunctions or out-of-control periods, or required monitoring system quality assurance or control activities... collect data according to this section. (b) You must operate the monitoring system and collect data at all required intervals at all times the affected source is operating except for periods of monitoring system...

40 CFR 63.11221 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2011 CFR

2011-07-01

... malfunctions or out-of-control periods, or required monitoring system quality assurance or control activities... collect data according to this section. (b) You must operate the monitoring system and collect data at all required intervals at all times the affected source is operating except for periods of monitoring system...

A system framework of inter-enterprise machining quality control based on fractal theory

NASA Astrophysics Data System (ADS)

Zhao, Liping; Qin, Yongtao; Yao, Yiyong; Yan, Peng

2014-03-01

In order to meet the quality control requirement of dynamic and complicated product machining processes among enterprises, a system framework of inter-enterprise machining quality control based on fractal was proposed. In this system framework, the fractal-specific characteristic of inter-enterprise machining quality control function was analysed, and the model of inter-enterprise machining quality control was constructed by the nature of fractal structures. Furthermore, the goal-driven strategy of inter-enterprise quality control and the dynamic organisation strategy of inter-enterprise quality improvement were constructed by the characteristic analysis on this model. In addition, the architecture of inter-enterprise machining quality control based on fractal was established by means of Web service. Finally, a case study for application was presented. The result showed that the proposed method was available, and could provide guidance for quality control and support for product reliability in inter-enterprise machining processes.

Measuring Provider Performance for Physicians Participating in the Merit-Based Incentive Payment System.

PubMed

Squitieri, Lee; Chung, Kevin C

2017-07-01

In 2017, the Centers for Medicare and Medicaid Services began requiring all eligible providers to participate in the Quality Payment Program or face financial reimbursement penalty. The Quality Payment Program outlines two paths for provider participation: the Merit-Based Incentive Payment System and Advanced Alternative Payment Models. For the first performance period beginning in January of 2017, the Centers for Medicare and Medicaid Services estimates that approximately 83 to 90 percent of eligible providers will not qualify for participation in an Advanced Alternative Payment Model and therefore must participate in the Merit-Based Incentive Payment System program. The Merit-Based Incentive Payment System path replaces existing quality-reporting programs and adds several new measures to evaluate providers using four categories of data: (1) quality, (2) cost/resource use, (3) improvement activities, and (4) advancing care information. These categories will be combined to calculate a weighted composite score for each provider or provider group. Composite Merit-Based Incentive Payment System scores based on 2017 performance data will be used to adjust reimbursed payment in 2019. In this article, the authors provide relevant background for understanding value-based provider performance measurement. The authors also discuss Merit-Based Incentive Payment System reporting requirements and scoring methodology to provide plastic surgeons with the necessary information to critically evaluate their own practice capabilities in the context of current performance metrics under the Quality Payment Program.

High angle of attack flying qualities criteria for longitudinal rate command systems

NASA Technical Reports Server (NTRS)

Wilson, David J.; Citurs, Kevin D.; Davidson, John B.

1994-01-01

This study was designed to investigate flying qualities requirements of alternate pitch command systems for fighter aircraft at high angle of attack. Flying qualities design guidelines have already been developed for angle of attack command systems at 30, 45, and 60 degrees angle of attack, so this research fills a similar need for rate command systems. Flying qualities tasks that require post-stall maneuvering were tested during piloted simulations in the McDonnell Douglas Aerospace Manned Air Combat Simulation facility. A generic fighter aircraft model was used to test angle of attack rate and pitch rate command systems for longitudinal gross acquisition and tracking tasks at high angle of attack. A wide range of longitudinal dynamic variations were tested at 30, 45, and 60 degrees angle of attack. Pilot comments, Cooper-Harper ratings, and pilot induced oscillation ratings were taken from five pilots from NASA, USN, CAF, and McDonnell Douglas Aerospace. This data was used to form longitudinal design guidelines for rate command systems at high angle of attack. These criteria provide control law design guidance for fighter aircraft at high angle of attack, low speed flight conditions. Additional time history analyses were conducted using the longitudinal gross acquisition data to look at potential agility measures of merit and correlate agility usage to flying qualities boundaries. This paper presents an overview of this research.

Documenting quality improvement and patient safety efforts: the quality portfolio. A statement from the academic hospitalist taskforce.

PubMed

Taylor, Benjamin B; Parekh, Vikas; Estrada, Carlos A; Schleyer, Anneliese; Sharpe, Bradley

2014-01-01

Physicians increasingly investigate, work, and teach to improve the quality of care and safety of care delivery. The Society of General Internal Medicine Academic Hospitalist Task Force sought to develop a practical tool, the quality portfolio, to systematically document quality and safety achievements. The quality portfolio was vetted with internal and external stakeholders including national leaders in academic medicine. The portfolio was refined for implementation to include an outlined framework, detailed instructions for use and an example to guide users. The portfolio has eight categories including: (1) a faculty narrative, (2) leadership and administrative activities, (3) project activities, (4) education and curricula, (5) research and scholarship, (6) honors, awards, and recognition, (7) training and certification, and (8) an appendix. The authors offer this comprehensive, yet practical tool as a method to document quality and safety activities. It is relevant for physicians across disciplines and institutions and may be useful as a standalone document or as an adjunct to traditional promotion documents. As the Next Accreditation System is implemented, academic medical centers will require faculty who can teach and implement the systems-based practice requirements. The quality portfolio is a method to document quality improvement and safety activities.

Medicare program; hospital outpatient prospective payment system and CY 2007 payment rates; CY 2007 update to the ambulatory surgical center covered procedures list; Medicare administrative contractors; and reporting hospital quality data for FY 2008 inpatient prospective payment system annual payment update program--HCAHPS survey, SCIP, and mortality. Final rule with comment period and final rule.

PubMed

2006-11-24

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system. This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicare-approved ambulatory surgical center (ASC), which are applicable to services furnished on or after January 1, 2007. This final rule with comment period revises the emergency medical screening requirements for critical access hospitals (CAHs). This final rule with comment period supports implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This final rule continues to implement the requirements of the DRA that require that we expand the "starter set" of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital inpatient prospective payment system (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. In this rule, we are finalizing additional quality measures for the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.

Radiation safety requirements for radioactive waste management in the framework of a quality management system

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

Salgado, M.M.; Benitez, J.C.; Pernas, R.

2007-07-01

The Center for Radiation Protection and Hygiene (CPHR) is the institution responsible for the management of radioactive wastes generated from nuclear applications in medicine, industry and research in Cuba. Radioactive Waste Management Service is provided at a national level and it includes the collection and transportation of radioactive wastes to the Centralized Waste Management Facilities, where they are characterized, segregated, treated, conditioned and stored. A Quality Management System, according to the ISO 9001 Standard has been implemented for the RWM Service at CPHR. The Management System includes the radiation safety requirements established for RWM in national regulations and in themore » Licence's conditions. The role of the Regulatory Body and the Radiation Protection Officer in the Quality Management System, the authorization of practices, training and personal qualification, record keeping, inspections of the Regulatory Body and internal inspection of the Radiation Protection Officer, among other aspects, are described in this paper. The Quality Management System has shown to be an efficient tool to demonstrate that adequate measures are in place to ensure the safety in radioactive waste management activities and their continual improvement. (authors)« less

Quality Management and Key Performance Indicators in Oncologic Esophageal Surgery.

PubMed

Gockel, Ines; Ahlbrand, Constantin Johannes; Arras, Michael; Schreiber, Elke Maria; Lang, Hauke

2015-12-01

Ranking systems and comparisons of quality and performance indicators will be of increasing relevance for complex "high-risk" procedures such as esophageal cancer surgery. The identification of evidence-based standards relevant for key performance indicators in esophageal surgery is essential for establishing monitoring systems and furthermore a requirement to enhance treatment quality. In the course of this review, we analyze the key performance indicators case volume, radicality of resection, and postoperative morbidity and mortality, leading to continuous quality improvement. Ranking systems established on this basis will gain increased relevance in highly complex procedures within the national and international comparison and furthermore improve the treatment of patients with esophageal carcinoma.

77 FR 73611 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

...: Negative Quality Control Review Schedule. OMB Control Number: 0584-0034. Summary of Collection: The legislative basis for the operation of the quality control system is provided by section 16 of the Food and Nutrition Act of 2008. State agencies are required to perform Quality Control (QC) reviews for the...

Development of the supply chain oriented quality assurance system for aerospace manufacturing SMEs and its implementation perspectives

NASA Astrophysics Data System (ADS)

Hussein, Abdullahi; Cheng, Kai

2016-10-01

Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements... utilization management programs, quality assurance measures and systems, and medication therapy management... organization (QIO) activities. (f) Compliance deemed on the basis of accreditation. (g) Accreditation...

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...

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...

Software Dependability and Safety Evaluations ESA's Initiative

NASA Astrophysics Data System (ADS)

Hernek, M.

ESA has allocated funds for an initiative to evaluate Dependability and Safety methods of Software. The objectives of this initiative are; · More extensive validation of Safety and Dependability techniques for Software · Provide valuable results to improve the quality of the Software thus promoting the application of Dependability and Safety methods and techniques. ESA space systems are being developed according to defined PA requirement specifications. These requirements may be implemented through various design concepts, e.g. redundancy, diversity etc. varying from project to project. Analysis methods (FMECA. FTA, HA, etc) are frequently used during requirements analysis and design activities to assure the correct implementation of system PA requirements. The criticality level of failures, functions and systems is determined and by doing that the critical sub-systems are identified, on which dependability and safety techniques are to be applied during development. Proper performance of the software development requires the development of a technical specification for the products at the beginning of the life cycle. Such technical specification comprises both functional and non-functional requirements. These non-functional requirements address characteristics of the product such as quality, dependability, safety and maintainability. Software in space systems is more and more used in critical functions. Also the trend towards more frequent use of COTS and reusable components pose new difficulties in terms of assuring reliable and safe systems. Because of this, its dependability and safety must be carefully analysed. ESA identified and documented techniques, methods and procedures to ensure that software dependability and safety requirements are specified and taken into account during the design and development of a software system and to verify/validate that the implemented software systems comply with these requirements [R1].

48 CFR 846.302-73 - Noncompliance with packaging, packing and/or marking requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Noncompliance with packaging, packing and/or marking requirements. 846.302-73 Section 846.302-73 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Clauses 846...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

Quality management for the processing of medical devices

PubMed Central

Klosz, Kerstin

2008-01-01

Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

Audits for advanced treatment dosimetry

NASA Astrophysics Data System (ADS)

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

2015-01-01

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

Quality requirements for EHR archetypes.

PubMed

Kalra, Dipak; Tapuria, Archana; Austin, Tony; De Moor, Georges

2012-01-01

The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

A System for Cost and Reimbursement Control in Hospitals

PubMed Central

Fetter, Robert B.; Thompson, John D.; Mills, Ronald E.

1976-01-01

This paper approaches the design of a regional or statewide hospital rate-setting system as the underpinning of a larger system which permits a regulatory agency to satisfy the requirements of various public laws now on the books or in process. It aims to generate valid interinstitutional monitoring on the three parameters of cost, utilization, and quality review. Such an approach requires the extension of the usual departmental cost and budgeting system to include consideration of the mix of patients treated and the utilization of various resources, including patient days, in the treatment of these patients. A sampling framework for the application of process-based quality studies and the generation of selected performance measurements is also included. PMID:941461

Evaluation of ARCAM Deposited Ti-6Al-4V

NASA Technical Reports Server (NTRS)

Slattery, Kevin; Slaughter, Blake; Speorl, Emily; Good, James; Gilley, Scott; McLemore, Carole

2008-01-01

A wide range of Metal Additive Manufacturing (MAM) technologies are becoming available. One of the challenges in using new technologies for aerospace systems is demonstrating that the process and system has the ability to manufacture components that meet the high quality requirements on a statistically significant basis. The widest-used system for small to medium sized components is the ARCAM system manufactured in Gothenburg, Sweden. This system features a 4kW electron-beam gun, and has a chamber volume of 250mm long x 250mm wide x 250mm to 400mm tall. This paper will describe the basis for the quality and consistency requirements, the experimental and evaluation procedures used for the evaluation, and an analysis of the results for Ti-6Al-4V.

48 CFR 46.301 - Contractor inspection requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Contractor inspection... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Clauses 46.301 Contractor inspection requirements. The contracting officer shall insert the clause at 52.246-1, Contractor Inspection Requirements, in solicitations...

Development of a Data Collection Tool for MbHIS-QUAL: Evaluation of the Quality of Morbidity Data in Routine Health Information Systems (RHISs) in Hospitals.

PubMed

Hanmer, Lyn; Nicola, Edward; Bradshaw, Debbie

2017-01-01

The quality of morbidity data in multiple routine inpatient records in a sample of South African hospitals is being assessed in terms of data accuracy and completeness. Extensive modification of available data collection tools was required to make it possible to collect the required data for the study.

Capacity of the US food system to accommodate improved diet quality: A biophysical model projecting to 2030

USDA-ARS?s Scientific Manuscript database

Background: Increasing Americans’ diet quality will require changes to the food supply. Due to the complex nature of the food system, this is not as straightforward as simply increasing the production of healthy foods and decreasing the production of unhealthy foods. Little is known about whether th...

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.

Sleep Quality Estimation based on Chaos Analysis for Heart Rate Variability

NASA Astrophysics Data System (ADS)

Fukuda, Toshio; Wakuda, Yuki; Hasegawa, Yasuhisa; Arai, Fumihito; Kawaguchi, Mitsuo; Noda, Akiko

In this paper, we propose an algorithm to estimate sleep quality based on a heart rate variability using chaos analysis. Polysomnography(PSG) is a conventional and reliable system to diagnose sleep disorder and to evaluate its severity and therapeatic effect, by estimating sleep quality based on multiple channels. However, a recording process requires a lot of time and a controlled environment for measurement and then an analyzing process of PSG data is hard work because the huge sensed data should be manually evaluated. On the other hand, it is focused that some people make a mistake or cause an accident due to lost of regular sleep and of homeostasis these days. Therefore a simple home system for checking own sleep is required and then the estimation algorithm for the system should be developed. Therefore we propose an algorithm to estimate sleep quality based only on a heart rate variability which can be measured by a simple sensor such as a pressure sensor and an infrared sensor in an uncontrolled environment, by experimentally finding the relationship between chaos indices and sleep quality. The system including the estimation algorithm can inform patterns and quality of own daily sleep to a user, and then the user can previously arranges his life schedule, pays more attention based on sleep results and consult with a doctor.

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

2014-01-01

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

Advanced Integrated Display System V/STOL Program Performance Specification. Volume I.

DTIC Science & Technology

1980-06-01

sensor inputs required before the sensor can be designated acceptable. The reactivation count of each sensor parameter which satisfies its veri...129 3.5.2 AIDS Configuration Parameters .............. 133 3.5.3 AIDS Throughput Requirements ............... 133 4 QUALITY ASSURANCE...lists the adaptation parameters of the AIDS software; these parameters include the throughput and memory requirements of the software. 3.2 SYSTEM

Practical, Real-Time, and Robust Watermarking on the Spatial Domain for High-Definition Video Contents

NASA Astrophysics Data System (ADS)

Kim, Kyung-Su; Lee, Hae-Yeoun; Im, Dong-Hyuck; Lee, Heung-Kyu

Commercial markets employ digital right management (DRM) systems to protect valuable high-definition (HD) quality videos. DRM system uses watermarking to provide copyright protection and ownership authentication of multimedia contents. We propose a real-time video watermarking scheme for HD video in the uncompressed domain. Especially, our approach is in aspect of practical perspectives to satisfy perceptual quality, real-time processing, and robustness requirements. We simplify and optimize human visual system mask for real-time performance and also apply dithering technique for invisibility. Extensive experiments are performed to prove that the proposed scheme satisfies the invisibility, real-time processing, and robustness requirements against video processing attacks. We concentrate upon video processing attacks that commonly occur in HD quality videos to display on portable devices. These attacks include not only scaling and low bit-rate encoding, but also malicious attacks such as format conversion and frame rate change.

Space Station Freedom - Configuration management approach to supporting concurrent engineering and total quality management. [for NASA Space Station Freedom Program

NASA Technical Reports Server (NTRS)

Gavert, Raymond B.

1990-01-01

Some experiences of NASA configuration management in providing concurrent engineering support to the Space Station Freedom program for the achievement of life cycle benefits and total quality are discussed. Three change decision experiences involving tracing requirements and automated information systems of the electrical power system are described. The potential benefits of concurrent engineering and total quality management include improved operational effectiveness, reduced logistics and support requirements, prevention of schedule slippages, and life cycle cost savings. It is shown how configuration management can influence the benefits attained through disciplined approaches and innovations that compel consideration of all the technical elements of engineering and quality factors that apply to the program development, transition to operations and in operations. Configuration management experiences involving the Space Station program's tiered management structure, the work package contractors, international partners, and the participating NASA centers are discussed.

Organising a University Computer System: Analytical Notes.

ERIC Educational Resources Information Center

Jacquot, J. P.; Finance, J. P.

1990-01-01

Thirteen trends in university computer system development are identified, system user requirements are analyzed, critical system qualities are outlined, and three options for organizing a computer system are presented. The three systems include a centralized network, local network, and federation of local networks. (MSE)

Enabling nutrient security and sustainability through systems research.

PubMed

Kaput, Jim; Kussmann, Martin; Mendoza, Yery; Le Coutre, Ronit; Cooper, Karen; Roulin, Anne

2015-05-01

Human and companion animal health depends upon nutritional quality of foods. Seed varieties, seasonal and local growing conditions, transportation, food processing, and storage, and local food customs can influence the nutrient content of food. A new and intensive area of investigation is emerging that recognizes many factors in these agri-food systems that influence the maintenance of nutrient quality which is fundamental to ensure nutrient security for world populations. Modeling how these systems function requires data from different sectors including agricultural, environmental, social, and economic, but also must incorporate basic nutrition and other biomedical sciences. Improving the agri-food system through advances in pre- and post-harvest processing methods, biofortification, or fortifying processed foods will aid in targeting nutrition for populations and individuals. The challenge to maintain and improve nutrient quality is magnified by the need to produce food locally and globally in a sustainable and consumer-acceptable manner for current and future populations. An unmet requirement for assessing how to improve nutrient quality, however, is the basic knowledge of how to define health. That is, health cannot be maintained or improved by altering nutrient quality without an adequate definition of what health means for individuals and populations. Defining and measuring health therefore becomes a critical objective for basic nutritional and other biomedical sciences.

Importance of Requirements Analysis & Traceability to Improve Software Quality and Reduce Cost and Risk

NASA Technical Reports Server (NTRS)

Kapoor, Manju M.; Mehta, Manju

2010-01-01

The goal of this paper is to emphasize the importance of developing complete and unambiguous requirements early in the project cycle (prior to Preliminary Design Phase). Having a complete set of requirements early in the project cycle allows sufficient time to generate a traceability matrix. Requirements traceability and analysis are the key elements in improving verification and validation process, and thus overall software quality. Traceability can be most beneficial when the system changes. If changes are made to high-level requirements it implies that low-level requirements need to be modified. Traceability ensures that requirements are appropriately and efficiently verified at various levels whereas analysis ensures that a rightly interpreted set of requirements is produced.

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

Are university rankings useful to improve research? A systematic review

PubMed Central

Momani, Shaher

2018-01-01

Introduction Concerns about reproducibility and impact of research urge improvement initiatives. Current university ranking systems evaluate and compare universities on measures of academic and research performance. Although often useful for marketing purposes, the value of ranking systems when examining quality and outcomes is unclear. The purpose of this study was to evaluate usefulness of ranking systems and identify opportunities to support research quality and performance improvement. Methods A systematic review of university ranking systems was conducted to investigate research performance and academic quality measures. Eligibility requirements included: inclusion of at least 100 doctoral granting institutions, be currently produced on an ongoing basis and include both global and US universities, publish rank calculation methodology in English and independently calculate ranks. Ranking systems must also include some measures of research outcomes. Indicators were abstracted and contrasted with basic quality improvement requirements. Exploration of aggregation methods, validity of research and academic quality indicators, and suitability for quality improvement within ranking systems were also conducted. Results A total of 24 ranking systems were identified and 13 eligible ranking systems were evaluated. Six of the 13 rankings are 100% focused on research performance. For those reporting weighting, 76% of the total ranks are attributed to research indicators, with 24% attributed to academic or teaching quality. Seven systems rely on reputation surveys and/or faculty and alumni awards. Rankings influence academic choice yet research performance measures are the most weighted indicators. There are no generally accepted academic quality indicators in ranking systems. Discussion No single ranking system provides a comprehensive evaluation of research and academic quality. Utilizing a combined approach of the Leiden, Thomson Reuters Most Innovative Universities, and the SCImago ranking systems may provide institutions with a more effective feedback for research improvement. Rankings which extensively rely on subjective reputation and “luxury” indicators, such as award winning faculty or alumni who are high ranking executives, are not well suited for academic or research performance improvement initiatives. Future efforts should better explore measurement of the university research performance through comprehensive and standardized indicators. This paper could serve as a general literature citation when one or more of university ranking systems are used in efforts to improve academic prominence and research performance. PMID:29513762

Technology and outcomes assessment in lung transplantation.

PubMed

Yusen, Roger D

2009-01-15

Lung transplantation offers the hope of prolonged survival and significant improvement in quality of life to patients that have advanced lung diseases. However, the medical literature lacks strong positive evidence and shows conflicting information regarding survival and quality of life outcomes related to lung transplantation. Decisions about the use of lung transplantation require an assessment of trade-offs: do the potential health and quality of life benefits outweigh the potential risks and harms? No amount of theoretical reasoning can resolve this question; empiric data are needed. Rational analyses of these trade-offs require valid measurements of the benefits and harms to the patients in all relevant domains that affect survival and quality of life. Lung transplant systems and registries mainly focus outcomes assessment on patient survival on the waiting list and after transplantation. Improved analytic approaches allow comparisons of the survival effects of lung transplantation versus continued waiting. Lung transplant entities do not routinely collect quality of life data. However, the medical community and the public want to know how lung transplantation affects quality of life. Given the huge stakes for the patients, the providers, and the healthcare systems, key stakeholders need to further support quality of life assessment in patients with advanced lung disease that enter into the lung transplant systems. Studies of lung transplantation and its related technologies should assess patients with tools that integrate both survival and quality of life information. Higher quality information obtained will lead to improved knowledge and more informed decision making.

Real-time control of combined surface water quantity and quality: polder flushing.

PubMed

Xu, M; van Overloop, P J; van de Giesen, N C; Stelling, G S

2010-01-01

In open water systems, keeping both water depths and water quality at specified values is critical for maintaining a 'healthy' water system. Many systems still require manual operation, at least for water quality management. When applying real-time control, both quantity and quality standards need to be met. In this paper, an artificial polder flushing case is studied. Model Predictive Control (MPC) is developed to control the system. In addition to MPC, a 'forward estimation' procedure is used to acquire water quality predictions for the simplified model used in MPC optimization. In order to illustrate the advantages of MPC, classical control [Proportional-Integral control (PI)] has been developed for comparison in the test case. The results show that both algorithms are able to control the polder flushing process, but MPC is more efficient in functionality and control flexibility.

21 CFR 26.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

CRN5EXP: Expert system for statistical quality control

NASA Technical Reports Server (NTRS)

Hentea, Mariana

1991-01-01

The purpose of the Expert System CRN5EXP is to assist in checking the quality of the coils at two very important mills: Hot Rolling and Cold Rolling in a steel plant. The system interprets the statistical quality control charts, diagnoses and predicts the quality of the steel. Measurements of process control variables are recorded in a database and sample statistics such as the mean and the range are computed and plotted on a control chart. The chart is analyzed through patterns using the C Language Integrated Production System (CLIPS) and a forward chaining technique to reach a conclusion about the causes of defects and to take management measures for the improvement of the quality control techniques. The Expert System combines the certainty factors associated with the process control variables to predict the quality of the steel. The paper presents the approach to extract data from the database, the reason to combine certainty factors, the architecture and the use of the Expert System. However, the interpretation of control charts patterns requires the human expert's knowledge and lends to Expert Systems rules.

Mobile data buoy system. [water quality measurements in watersheds and Mobile Bay, Alabama

NASA Technical Reports Server (NTRS)

Morton, R. A.

1975-01-01

The Mobile Data Buoy System was conceived to serve the users requirement for obtaining water quality parameters from two separate watershed systems. In view of the cost constraints of the ERTS program it was obvious that the network of 10 sampling stations required could not be of the fixed installation type; therefore, it was decided to go to a system of battery powered buoys of a size that could be used in one watershed system for a period of time and then moved to another by use of a relatively small 6.7 m (22 foot) boat. The basic idea of the water quality measurement program was to establish the water quality pattern of change from the headwaters of the watersheds to and through the Mobile Bay. This would allow the investigator to develop a good picture of the state's major water resources and the pressures from pollution that are being imposed. At this point in deployment of this mobile system of buoys, it is too early to put a quantitative value on the system, however it appears less expensive than known fixed installations as to first cost. It has a basic advantage in that it can be moved, at very little expense, to alternate sites where it is desired to obtain water quality data. It is to be noted this buoy system which covers a 80 Km (50 mile) stretch of the Black Warrior River and then skips down 483 Km (300 miles) to Mobile Bay for the next measurements would not be feasible unless there is a satellite to collect and relay the data.

Ultrasonic Real-Time Quality Monitoring Of Aluminum Spot Weld Process

NASA Astrophysics Data System (ADS)

Perez Regalado, Waldo Josue

The real-time ultrasonic spot weld monitoring system, introduced by our research group, has been designed for the unsupervised quality characterization of the spot welding process. It comprises the ultrasonic transducer (probe) built into one of the welding electrodes and an electronics hardware unit which gathers information from the transducer, performs real-time weld quality characterization and communicates with the robot programmable logic controller (PLC). The system has been fully developed for the inspection of spot welds manufactured in steel alloys, and has been mainly applied in the automotive industry. In recent years, a variety of materials have been introduced to the automotive industry. These include high strength steels, magnesium alloys, and aluminum alloys. Aluminum alloys have been of particular interest due to their high strength-to-weight ratio. Resistance spot welding requirements for aluminum vary greatly from those of steel. Additionally, the oxide film formed on the aluminum surface increases the heat generation between the copper electrodes and the aluminum plates leading to accelerated electrode deterioration. Preliminary studies showed that the real-time quality inspection system was not able to monitor spot welds manufactured with aluminum. The extensive experimental research, finite element modelling of the aluminum welding process and finite difference modeling of the acoustic wave propagation through the aluminum spot welds presented in this dissertation, revealed that the thermodynamics and hence the acoustic wave propagation through an aluminum and a steel spot weld differ significantly. For this reason, the hardware requirements and the algorithms developed to determine the welds quality from the ultrasonic data used on steel, no longer apply on aluminum spot welds. After updating the system and designing the required algorithms, parameters such as liquid nugget penetration and nugget diameter were available in the ultrasonic data acquired during the aluminum welding process. Finally, a fuzzy system was designed to receive these parameters and determine the weld quality.

The role of criteria in design and management of space systems

NASA Technical Reports Server (NTRS)

Blair, J. C.; Ryan, R. S.

1992-01-01

Explicit requirements and standards arising in connection with space systems management serve as a framework for technical management and furnish legally binding control of development, verification, and operations. As a project develops, additional requirements are derived which are unique to the system in question; these are designated 'derived requirements'. The reliability and cost-effectiveness of a space system are best ensured where a balance has arisen between formal (legally binding) and informal. Attention is presently given to the development of criteria consistent with total quality management.

MO-E-217A-01: Contrast-Enhanced Spectral Mammography - Physical Aspects and QA.

PubMed

Yaffe, M; Hill, M

2012-06-01

To describe the current state of dual energy contrast-enhanced digital mammography, to discuss those aspects of its operation that require evaluation or monitoring and to propose elements of a program for quality assurance of such systems. The principles of dual-energy contrast imaging will be discussed and tools and techniques for assessment of performance will be described. Many of the elements affecting image quality and dose performance in digital mammography (eg noise, system linearity, consistency of x-ray output and detector performance, artifacts) remain important. In addition, the ability to register images can influence the resultant image quality. The maintenance of breast compression thickness during the imaging procedure and calibration of the system to allow quantification of iodine in the breast represent new challenges to quality assurance. CESM provides a means of acquiring new information regarding tumor angiogenesis and may reveal some cancers that will not be detectable on digital mammography. It may also better demonstrate the extent of disease. The medical physicist must understand the dependence of image quality on physical factors. Implementation of a relevant QA program will be required if the promise of this new modality is to be delivered. © 2012 American Association of Physicists in Medicine.

[Quality management and strategic consequences of assessing documentation and coding under the German Diagnostic Related Groups system].

PubMed

Schnabel, M; Mann, D; Efe, T; Schrappe, M; V Garrel, T; Gotzen, L; Schaeg, M

2004-10-01

The introduction of the German Diagnostic Related Groups (D-DRG) system requires redesigning administrative patient management strategies. Wrong coding leads to inaccurate grouping and endangers the reimbursement of treatment costs. This situation emphasizes the roles of documentation and coding as factors of economical success. The aims of this study were to assess the quantity and quality of initial documentation and coding (ICD-10 and OPS-301) and find operative strategies to improve efficiency and strategic means to ensure optimal documentation and coding quality. In a prospective study, documentation and coding quality were evaluated in a standardized way by weekly assessment. Clinical data from 1385 inpatients were processed for initial correctness and quality of documentation and coding. Principal diagnoses were found to be accurate in 82.7% of cases, inexact in 7.1%, and wrong in 10.1%. Effects on financial returns occurred in 16%. Based on these findings, an optimized, interdisciplinary, and multiprofessional workflow on medical documentation, coding, and data control was developed. Workflow incorporating regular assessment of documentation and coding quality is required by the DRG system to ensure efficient accounting of hospital services. Interdisciplinary and multiprofessional cooperation is recognized to be an important factor in establishing an efficient workflow in medical documentation and coding.

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

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

Newsom, H.C.

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

Requirements for Real-Time Laboratory Experimentation over the Internet.

ERIC Educational Resources Information Center

Salzmann, C.; Latchman, H. A.; Gillet, D.; Crisalle, O. D.

A prototype system based on an inverted pendulum is used to study the Quality of Service and discuss requirements of remote-experimentation systems utilized for carrying out control engineering experiments over the Internet. This class of applications involves the transmission over the network of a variety of data types with their own peculiar…

77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane... Organization for Standardization (ISO) 13485:2003 ``Medical devices--Quality management systems--Requirements... management systems--Requirements for regulatory purposes,'' (ISO 13485:2003) or a national adoption of this...

General Guide for Community College System Physical Planning. 2nd Printing.

ERIC Educational Resources Information Center

Mogi, Hitoshi

Part I describes a general outline for producing long range development plans for the Hawaii Community College System. Long-range planning is defined and discussed in terms of basic elements of academic requirements, quality of campus, space requirements, environmental factors, administrative factors, and adjustment factors of the general plans.…

The effects of housing systems for laying hens on egg safety and quality

USDA-ARS?s Scientific Manuscript database

Transitions in laying hen management and housing systems have constantly occurred throughout the history of commercial egg production. Around the world, there has been a rapid shift in hen housing requirements since the turn of the current century. In most cases, the changes in hen housing require...

Joint Optics Structures Experiment (JOSE)

NASA Technical Reports Server (NTRS)

Founds, David

1987-01-01

The objectives of the JOSE program is to develop, demonstrate, and evaluate active vibration suppression techniques for Directed Energy Weapons (DEW). DEW system performance is highly influenced by the line-of-sight (LOS) stability and in some cases by the wave front quality. The missions envisioned for DEW systems by the Strategic Defense Initiative require LOS stability and wave front quality to be significantly improved over any current demonstrated capability. The Active Control of Space Structures (ACOSS) program led to the development of a number of promising structural control techniques. DEW structures are vastly more complex than any structures controlled to date. They will be subject to disturbances with significantly higher magnitudes and wider bandwidths, while holding higher tolerances on allowable motions and deformations. Meeting the performance requirements of the JOSE program requires upgrading the ACOSS techniques to meet new more stringent requirements, the development of requisite sensors and acturators, improved control processors, highly accurate system identification methods, and the integration of hardware and methodologies into a successful demonstration.

Public health laboratory quality management in a developing country.

PubMed

Wangkahat, Khwanjai; Nookhai, Somboon; Pobkeeree, Vallerut

2012-01-01

The article aims to give an overview of the system of public health laboratory quality management in Thailand and to produce a strengths, weaknesses, opportunities and threats (SWOT) analysis that is relevant to public health laboratories in the country. The systems for managing laboratory quality that are currently employed were described in the first component. The second component was a SWOT analysis, which used the opinions of laboratory professionals to identify any areas that could be improved to meet quality management systems. Various quality management systems were identified and the number of laboratories that met both international and national quality management requirements was different. The SWOT analysis found the opportunities and strengths factors offered the best chance to improve laboratory quality management in the country. The results are based on observations and brainstorming with medical laboratory professionals who can assist laboratories in accomplishing quality management. The factors derived from the analysis can help improve laboratory quality management in the country. This paper provides viewpoints and evidence-based approaches for the development of best possible practice of services in public health laboratories.

Installing Portable Classrooms With Good Air Quality.

ERIC Educational Resources Information Center

Godfrey, Ray

2000-01-01

Discusses the advantages of modular classrooms and improvements made in indoor air quality, including the pros and cons of portables, challenges districts face when planning and installing portables, and cost considerations. Concluding comments highlight system costs and maintenance required. (GR)

40 CFR 30.54 - Quality assurance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER... Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs”, which may be obtained from the National Technical Information Service (NTIS), 5885 Port Royal Road...

40 CFR 30.54 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER... Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs”, which may be obtained from the National Technical Information Service (NTIS), 5885 Port Royal Road...

40 CFR 30.54 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER... Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs”, which may be obtained from the National Technical Information Service (NTIS), 5885 Port Royal Road...

40 CFR 30.54 - Quality assurance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER... Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs”, which may be obtained from the National Technical Information Service (NTIS), 5885 Port Royal Road...

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.

42 CFR 493.1230 - Condition: General laboratory systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory that...

Landing flying qualities evaluation criteria for augmented aircraft

NASA Technical Reports Server (NTRS)

Radford, R. C.; Smith, R.; Bailey, R.

1980-01-01

The criteria evaluated were: Calspan Neal-Smith; Onstott (Northrop Time Domain); McDonnell-Douglas Equivalent System Approach; R. H. Smith Criterion. Each criterion was applied to the same set of longitudinal approach and landing flying qualities data. A revised version of the Neal-Smith criterion which is applicable to the landing task was developed and tested against other landing flying qualities data. Results indicated that both the revised Neal-Smith criterion and the Equivalent System Approach are good discriminators of pitch landing flying qualities; Neal-Smith has particular merit as a design guide, while the Equivalent System Approach is well suited for development of appropriate military specification requirements applicable to highly augmented aircraft.

Modelling health care processes for eliciting user requirements: a way to link a quality paradigm and clinical information system design.

PubMed

Staccini, P; Joubert, M; Quaranta, J F; Fieschi, D; Fieschi, M

2001-12-01

Healthcare institutions are looking at ways to increase their efficiency by reducing costs while providing care services with a high level of safety. Thus, hospital information systems have to support quality improvement objectives. The elicitation of the requirements has to meet users' needs in relation to both the quality (efficacy, safety) and the monitoring of all health care activities (traceability). Information analysts need methods to conceptualise clinical information systems that provide actors with individual benefits and guide behavioural changes. A methodology is proposed to elicit and structure users' requirements using a process-oriented analysis, and it is applied to the blood transfusion process. An object-oriented data model of a process has been defined in order to organise the data dictionary. Although some aspects of activity, such as 'where', 'what else', and 'why' are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for the processes to be interrelated, and for their characteristics to be shared, in order to avoid data redundancy and to fit the gathering of data with the provision of care.

[Introduction of Quality Management System Audit in Medical Device Single Audit Program].

PubMed

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-01-30

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

Evaluation of the sustainability of contrasted pig farming systems: development of a market conformity tool for pork products based on technological quality traits.

PubMed

Gonzàlez, J; Gispert, M; Gil, M; Hviid, M; Dourmad, J Y; de Greef, K H; Zimmer, C; Fàbrega, E

2014-12-01

A market conformity tool, based on technological meat quality parameters, was developed within the Q-PorkChains project, to be included in a global sustainability evaluation of pig farming systems. The specific objective of the market conformity tool was to define a scoring system based on the suitability of meat to elaborate the main pork products, according to their market shares based on industry requirements, in different pig farming systems. The tool was based on carcass and meat quality parameters that are commonly used for the assessment of technological quality, which provide representative and repeatable data and are easily measurable. They were the following: cold carcass weight; lean meat percentage; minimum subcutaneous back fat depth at m. gluteus medius level, 45 postmortem and ultimate pH (measured at 24-h postmortem) in m. longissimus lumborum and semimembranosus; meat colour; drip losses and intramuscular fat content in a m. longissimus sample. Five categories of pork products produced at large scale in Europe were considered in the study: fresh meat, cooked products, dry products, specialties and other meat products. For each of the studied farming systems, the technological meat quality requirements, as well as the market shares for each product category within farming system, were obtained from the literature and personal communications from experts. The tool resulted in an overall conformity score that enabled to discriminate among systems according to the degree of matching of the achieved carcass and meat quality with the requirements of the targeted market. In order to improve feasibility, the tool was simplified by selecting ultimate pH at m. longissimus or semimembranosus, minimum fat thickness measured at the left half carcass over m. gluteus medius and intramuscular fat content in a m. longissimus sample as iceberg indicators. The overall suitability scores calculated by using both the complete and the reduced tools presented good correlation and the results obtained were similar. The tool could be considered as robust enough to discriminate among different systems, since it was tested in a wide range of them. It also can be used to detect improvement opportunities to enhance sustainability of pig farming systems. The final objective of the study was achieved, since the market suitability tool could be used in an integrated sustainability analysis of pig farming systems.

Design of bunch compressing system with suppression of coherent synchrotron radiation for ATF upgrade

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

Jing, Yichao; Fedurin, Mikhail; Stratakis, Diktys

2015-05-03

One of the operation modes for Accelerator Test Facility (ATF) upgrade is to provide high peak current, high quality electron beam for users. Such operation requires a bunch compressing system with a very large compression ratio. The CSR originating from the strong compressors generally could greatly degrade the quality of the electron beam. In this paper, we present our design for the entire bunch compressing system that will limit the effect of CSR on the e-beam’s quality. We discuss and detail the performance from the start to end simulation of such a compressor for ATF.

The quantitative control and matching of an optical false color composite imaging system

NASA Astrophysics Data System (ADS)

Zhou, Chengxian; Dai, Zixin; Pan, Xizhe; Li, Yinxi

1993-10-01

Design of an imaging system for optical false color composite (OFCC) capable of high-precision density-exposure time control and color balance is presented. The system provides high quality FCC image data that can be analyzed using a quantitative calculation method. The quality requirement to each part of the image generation system is defined, and the distribution of satellite remote sensing image information is analyzed. The proposed technology makes it possible to present the remote sensing image data more effectively and accurately.

Current research trend on urban sewerage system in China

NASA Astrophysics Data System (ADS)

Ning, Yun-Fang; Dong, Wen-Yi; Lin, Lu-Sheng; Zhang, Qian

2017-03-01

The research emphasis has always been on sewerage treatment technology in China, though urban drainage system has gained little attention. In the context of urban drainage system and the problem associated with rain, the focus is still mainly toward the simple “emissions”. While the relationship between conservation and utilization of rainwater resources and urban ecology are popular, the relationship between rainwater discharge and non-point source pollution are often neglected. The reasonable choice of sewerage system is dependent on the collection and discharge of urban sewerage, the applicability and economic benefits, along with the ability to meet the water quality requirements and environmental protection. This paper analyzes and summarizes the development of urban drainage system in china, and introduces different drainage forms. The choice of drainage system should be based on the overall planning of the city, environmental protection requirements, the local natural conditions and water conditions, urban sewerage and water quality, the original drainage facilities, and local climatic conditions. It must be comprehensive to meet the environmental protection requirements, through technical and economic comparison.

48 CFR 7.101 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... produce quality systems. This includes ensuring that only necessary and cost-effective requirements are... that involve redesign of systems or subsystems. Life-cycle cost means the total cost to the Government...

48 CFR 7.101 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... produce quality systems. This includes ensuring that only necessary and cost-effective requirements are... that involve redesign of systems or subsystems. Life-cycle cost means the total cost to the Government...

Healthcare delivery systems: designing quality into health information systems.

PubMed

Joyce, Phil; Green, Rosamund; Winch, Graham

2007-01-01

To ensure that quality is 'engineered in' a holistic, integrated and quality approach is required, and Total Quality Management (TQM) principles are the obvious foundations for this. This paper describes a novel approach to viewing the operations of a healthcare provider where electronic means could be used to distribute information (including electronic fund settlements), building around the Full Service Provider core. Specifically, an approach called the "triple pair flow" model is used to provide a view of healthcare delivery that is integrated, yet detailed, and that combines the strategic enterprise view with a business process view.

Manufacturing Bms/Iso System Review

NASA Technical Reports Server (NTRS)

Gomez, Yazmin

2004-01-01

The Quality Management System (QMS) is one that recognizes the need to continuously change and improve an organization s products and services as determined by system feedback, and corresponding management decisions. The purpose of a Quality Management System is to minimize quality variability of an organization's products and services. The optimal Quality Management System balances the need for an organization to maintain flexibility in the products and services it provides with the need for providing the appropriate level of discipline and control over the processes used to provide them. The goal of a Quality Management System is to ensure the quality of the products and services while consistently (through minimizing quality variability) meeting or exceeding customer expectations. The GRC Business Management System (BMS) is the foundation of the Center's ISO 9001:2000 registered quality system. ISO 9001 is a quality system model developed by the International Organization for Standardization. BMS supports and promote the Glenn Research Center Quality Policy and wants to ensure the customer satisfaction while also meeting quality standards. My assignment during this summer is to examine the manufacturing processes used to develop research hardware, which in most cases are one of a kind hardware, made with non conventional equipment and materials. During this process of observation I will make a determination, based on my observations of the hardware development processes the best way to meet customer requirements and at the same time achieve the GRC quality standards. The purpose of my task is to review the manufacturing processes identifying opportunities in which to optimize the efficiency of the processes and establish a plan for implementation and continuous improvement.

A Novel Approach for Enhancement of Automobile Clutch Engagement Quality Using Mechatronics Based Automated Clutch System

NASA Astrophysics Data System (ADS)

Tripathi, K.

2013-01-01

In automated manual clutch (AMC) a mechatronic system controls clutch force trajectory through an actuator governed by a control system. The present study identifies relevant characteristics of this trajectory and their effects on driveline dynamics and engagement quality. A new type of force trajectory is identified which gives the good engagement quality. However this trajectory is not achievable through conventional clutch control mechanism. But in AMC a mechatronic system based on electro-hydraulic or electro-mechanical elements can make it feasible. A mechatronic system is presented in which a mechatronic add-on system can be used to implement the novel force trajectory, without the requirement of replacing the traditional diaphragm spring based clutch in a vehicle with manual transmission.

Generic waste management requirements for a controlled ecological life support system /CELSS/

NASA Technical Reports Server (NTRS)

Hoshizaki, T.; Hansen, B. D., III

1981-01-01

Regenerative life support systems for future space missions will require closure of the waste-food loop. Each mission application will generate specific requirements for the waste management system. However, there are generic input and output requirements that can be identified when a probable scenario is chosen. This paper discusses the generic requirements when higher plants are chosen as the primary food source. Attention is focused on the quality and quantity of nutrients necessary for culturing higher plants. The types of wastes to be processed are also discussed. In addition, requirements generated by growing plants on three different substrates are presented. This work suggests that the mineral composition of waste materials may require minimal adjustment to satisfy the plant requirements.

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

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

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

2015-06-01

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

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

PubMed

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

2017-12-01

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

Internal quality control: best practice.

PubMed

Kinns, Helen; Pitkin, Sarah; Housley, David; Freedman, Danielle B

2013-12-01

There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

Integrating modal-based NDE techniques and bridge management systems using quality management

NASA Astrophysics Data System (ADS)

Sikorsky, Charles S.

1997-05-01

The intent of bridge management systems is to help engineers and managers determine when and where to spend bridge funds such that commerce and the motoring public needs are satisfied. A major shortcoming which states are experiencing is the NBIS data available is insufficient to perform certain functions required by new bridge management systems, such as modeling bridge deterioration and predicting costs. This paper will investigate how modal based nondestructive damage evaluation techniques can be integrated into bridge management using quality management principles. First, quality from the manufacturing perspective will be summarized. Next, the implementation of quality management in design and construction will be reinterpreted for bridge management. Based on this, a theory of approach will be formulated to improve the productivity of a highway transportation system.

Evaluation of the NASA Quality Surveillance System Pilot in Meeting Requirements for Contractor Surveillance Under Performance Based Contracting

NASA Technical Reports Server (NTRS)

Schmahl, Karen E.

2002-01-01

The use of performance-based contracting at Kennedy Space Center has necessitated a shift from intrusive oversight of contractor activities to an insight surveillance role. This paper describes the results of a pilot implementation of the NASA Quality Surveillance System (NQSS) in the Space Shuttle Main Engines Processing Facility. The NQSS is a system to sample contractor activities using documented procedures, specifications, drawings and observations of work in progress to answer the question "Is the contractor doing what they said they would do?" The concepts of the NQSS are shown to be effective in providing assurance of contractor quality. Many of the concepts proven in the pilot are being considered for incorporation into an overall KSC Quality Surveillance System.

Evaluation Of The NASA Quality Surveillance System Pilot In Meeting Requirements For Contractor Surveillance Under Performance Based Contracting

NASA Technical Reports Server (NTRS)

Schmahl, Karen E.

2001-01-01

The use of performance-based contracting at Kennedy Space Center has necessitated a shift from intrusive oversight of contractor activities to an insight surveillance role. This paper describes the results of a pilot implementation of the NASA Quality Surveillance System (NQSS) in the Space Shuttle Main Engines Processing Facility. The NQSS is a system to sample contractor activities using documented procedures, specifications, drawings and observations of work in progress to answer the question "Is the contractor doing what they said they would do?" The concepts of the NQSS are shown to be effective in providing assurance of contractor quality. Many of the concepts proven in the pilot are being considered for incorporation into an overall KSC Quality Surveillance System.

System Considerations and Challendes in 3d Mapping and Modeling Using Low-Cost Uav Systems

NASA Astrophysics Data System (ADS)

Lari, Z.; El-Sheimy, N.

2015-08-01

In the last few years, low-cost UAV systems have been acknowledged as an affordable technology for geospatial data acquisition that can meet the needs of a variety of traditional and non-traditional mapping applications. In spite of its proven potential, UAV-based mapping is still lacking in terms of what is needed for it to become an acceptable mapping tool. In other words, a well-designed system architecture that considers payload restrictions as well as the specifications of the utilized direct geo-referencing component and the imaging systems in light of the required mapping accuracy and intended application is still required. Moreover, efficient data processing workflows, which are capable of delivering the mapping products with the specified quality while considering the synergistic characteristics of the sensors onboard, the wide range of potential users who might lack deep knowledge in mapping activities, and time constraints of emerging applications, are still needed to be adopted. Therefore, the introduced challenges by having low-cost imaging and georeferencing sensors onboard UAVs with limited payload capability, the necessity of efficient data processing techniques for delivering required products for intended applications, and the diversity of potential users with insufficient mapping-related expertise needs to be fully investigated and addressed by UAV-based mapping research efforts. This paper addresses these challenges and reviews system considerations, adaptive processing techniques, and quality assurance/quality control procedures for achievement of accurate mapping products from these systems.

A Systems Engineering Approach to Quality Assurance for Aerospace Testing

NASA Technical Reports Server (NTRS)

Shepherd, Christena C.

2014-01-01

On the surface, it appears that AS9100 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK) that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness. The Systems Engineering (SE) discipline is widely used in aerospace to ensure the progress from Stakeholder Expectations (the President, Congress, the taxpayers) to a successful, delivered product or service. Although this is well known, what is not well known is that these same SE processes are implemented in varying complexity, to prepare for and implement test projects that support research, development, verification and validation, qualification, and acceptance test projects. Although the test organization's terminology may vary from the SE terminology, and from one test service provider to another, the basic process is followed by successful, reliable testing organizations. For this analysis, NASA Procedural Requirements (NPR) 7123.1, NASA Systems Engineering Processes and Requirements is used to illustrate the SE processes that are used for major aerospace testing. Many of these processes are also implemented for smaller test projects, and this set of processes will also look familiar to those who have participated in launch site activation and flight demonstrations.

Total Quality Management and Media Services: The Deming Method.

ERIC Educational Resources Information Center

Richie, Mark L.

1992-01-01

W. Edwards Deming built a 40-year record of quality management in Japan known as Total Quality Management (TQM). His 14 points require a change in the belief system of managers and media directors, but their implementation in government agencies and schools will produce increased time for better services, better communications, and new programs.…

Adopting Self-Accreditation in Response to the Diversity of Higher Education: Quality Assurance in Taiwan and Its Impact on Institutions

ERIC Educational Resources Information Center

Chen, Karen Hui-Jung; Hou, Angela Yung-Chi

2016-01-01

In 2012, Taiwan implemented a dual-track quality assurance system comprising accreditation and self-accreditation in higher education institutions. Self-accrediting institutions can accredit their programs without requiring approval from external quality assurance agencies. In contrast to other countries, the Ministry of Education of Taiwan…

The Columbia River Protection Supplemental Technologies Quality Assurance Project Plan

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

Fix, N. J.

The U.S. Department of Energy (DOE) has conducted interim groundwater remedial activities on the Hanford Site since the mid-1990s for several groundwater contamination plumes. DOE established the Columbia River Protection Supplemental Technologies Project (Technologies Project) in 2006 to evaluate alternative treatment technologies. The objectives for the technology project are as follows: develop a 300 Area polyphosphate treatability test to immobilize uranium, design and test infiltration of a phosphate/apatite technology for Sr-90 at 100-N, perform carbon tetrachloride and chloroform attenuation parameter studies, perform vadose zone chromium characterization and geochemistry studies, perform in situ biostimulation of chromium studies for a reducing barriermore » at 100-D, and perform a treatability test for phytoremediation for Sr-90 at 100-N. This document provides the quality assurance guidelines that will be followed by the Technologies Project. This Quality Assurance Project Plan is based on the quality assurance requirements of DOE Order 414.1C, Quality Assurance, and 10 CFR 830, Subpart A--Quality Assurance Requirements as delineated in Pacific Northwest National Laboratory’s Standards-Based Management System. In addition, the technology project is subject to the Environmental Protection Agency (EPA) Requirements for Quality Assurance Project Plans (EPA/240/B-01/003, QA/R-5). The Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD, DOE/RL-96-68) apply to portions of this project and to the subcontractors. HASQARD requirements are discussed within applicable sections of this plan.« less

Systems, methods and apparatus for generation and verification of policies in autonomic computing systems

NASA Technical Reports Server (NTRS)

Rouff, Christopher A. (Inventor); Sterritt, Roy (Inventor); Truszkowski, Walter F. (Inventor); Hinchey, Michael G. (Inventor); Gracanin, Denis (Inventor); Rash, James L. (Inventor)

2011-01-01

Described herein is a method that produces fully (mathematically) tractable development of policies for autonomic systems from requirements through to code generation. This method is illustrated through an example showing how user formulated policies can be translated into a formal mode which can then be converted to code. The requirements-based programming method described provides faster, higher quality development and maintenance of autonomic systems based on user formulation of policies.Further, the systems, methods and apparatus described herein provide a way of analyzing policies for autonomic systems and facilities the generation of provably correct implementations automatically, which in turn provides reduced development time, reduced testing requirements, guarantees of correctness of the implementation with respect to the policies specified at the outset, and provides a higher degree of confidence that the policies are both complete and reasonable. The ability to specify the policy for the management of a system and then automatically generate an equivalent implementation greatly improves the quality of software, the survivability of future missions, in particular when the system will operate untended in very remote environments, and greatly reduces development lead times and costs.

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.

Tropospheric Passive Remote Sensing

NASA Technical Reports Server (NTRS)

Keafer, L. S., Jr. (Editor)

1982-01-01

The long term role of airborne/spaceborne passive remote sensing systems for tropospheric air quality research and the identification of technology advances required to improve the performance of passive remote sensing systems were discussed.

Quality assurance and risk management: Perspectives on Human Factors Certification of Advanced Aviation Systems

NASA Technical Reports Server (NTRS)

Taylor, Robert M.; Macleod, Iain S.

1994-01-01

This paper is based on the experience of engineering psychologists advising the U.K. Ministry of Defense (MoD) on the procurement of advanced aviation systems that conform to good human engineering (HE) practice. Traditional approaches to HE in systems procurement focus on the physical nature of the human-machine interface. Advanced aviation systems present increasingly complex design requirements for human functional integration, information processing, and cognitive task performance effectiveness. These developing requirements present new challenges for HE quality assurance (QA) and risk management, requiring focus on design processes as well as on design content or product. A new approach to the application of HE, recently adopted by NATO, provides more systematic ordering and control of HE processes and activities to meet the challenges of advanced aircrew systems design. This systematic approach to HE has been applied by MoD to the procurement of mission systems for the Royal Navy Merlin helicopter. In MoD procurement, certification is a judicial function, essentially independent of the service customer and industry contractor. Certification decisions are based on advice from MoD's appointed Acceptance Agency. Test and evaluation (T&E) conducted by the contractor and by the Acceptance Agency provide evidence for certification. Certification identifies limitations of systems upon release to the service. Evidence of compliance with HE standards traditionally forms the main basis of HE certification and significant non-compliance could restrict release. The systems HE approach shows concern for the quality of processes as well as for the content of the product. Human factors certification should be concerned with the quality of HE processes as well as products. Certification should require proof of process as well as proof of content and performance. QA criteria such as completeness, consistency, timeliness, and compatibility provide generic guidelines for progressive acceptance and certification of HE processes. Threats to the validity of certification arise from problems and assumptions in T&E methods. T&E should seek to reduce the risk of specification non-compliance and certification failure.

An importance-performance analysis of hospital information system attributes: A nurses' perspective.

PubMed

Cohen, Jason F; Coleman, Emma; Kangethe, Matheri J

2016-02-01

Health workers have numerous concerns about hospital IS (HIS) usage. Addressing these concerns requires understanding the system attributes most important to their satisfaction and productivity. Following a recent HIS implementation, our objective was to identify priorities for managerial intervention based on user evaluations of the performance of the HIS attributes as well as the relative importance of these attributes to user satisfaction and productivity outcomes. We collected data along a set of attributes representing system quality, data quality, information quality, and service quality from 154 nurse users. Their quantitative responses were analysed using the partial least squares approach followed by an importance-performance analysis. Qualitative responses were analysed using thematic analysis to triangulate and supplement the quantitative findings. Two system quality attributes (responsiveness and ease of learning), one information quality attribute (detail), one service quality attribute (sufficient support), and three data quality attributes (records complete, accurate and never missing) were identified as high priorities for intervention. Our application of importance-performance analysis is unique in HIS evaluation and we have illustrated its utility for identifying those system attributes for which underperformance is not acceptable to users and therefore should be high priorities for intervention. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Controls on the quality of harvested rainwater in residential systems

NASA Astrophysics Data System (ADS)

Sojka, S. L.; Phung, D.; Hollingsworth, C.

2014-12-01

Rainwater harvesting systems, in which runoff from roofs is collected and used for irrigation, toilets and other purposes, present a viable solution to limited freshwater supplies and excess stormwater runoff. However, a lack of data on the quality of harvested rainwater hinders adoption of rainwater harvesting systems and makes development of rainwater harvesting regulations difficult. We conducted monthly surveys of 6 existing residential rainwater harvesting systems ranging in age from 1 to 11 years measuring pH, temperature, dissolved oxygen, total suspended solids, dissolved organic carbon, and coliform bacteria. We also examined a subset of the samples for iron, lead, mercury and arsenic. Many of the systems routinely met the water quality requirements for non-potable use without additional treatment, which is often required by regulations. In addition, while previous studies have shown that roof runoff contains heavy metals, the water in all systems showed very low or undetectable levels of metal contamination. Coliform bacteria concentration ranged from 20 to greater than 1400 CFU's per 100 mL and correlated with total suspended solids, which ranged from 2 - 7 mg l-1. The relationship between suspended solids and bacteria population was confirmed in a controlled experiment on the impact of filtering the rainwater before storage. Filtration decreased total suspended solids and total coliforms and increased dissolved oxygen concentration. This project provides insight into the effects of system design and a baseline assessment of the quality of harvested rainwater in existing systems.

Data Use "Multi-State" Spotlight: Using Data Fidelity Tools to Improve Data Quality. Transforming State Systems to Improve Outcomes for Children with Disabilities

ERIC Educational Resources Information Center

Ruedel, Kristin; Nelson, Gena; Bailey, Tessie

2018-01-01

To evaluate interim progress toward the State-identified Measurable Result (SIMR), states require access to high-quality data from local education agencies (LEAs) and early intervention service providers. In a review of 2017 Phase III State Systemic Improvement Plans (SSIP), 43 Part C states noted limitations or concerns related to data and…

NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

NASA Technical Reports Server (NTRS)

Akers, James C.; Cooper, Beth A.

2004-01-01

NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive onsite assessment that includes proficiency testing and documentation review. The ATL NVLAP accreditation currently applies specifically to its ISO 3744 soundpower- level determination procedure (see the photograph) and supporting ISO 17025 quality system, although all ATL operations are conducted in accordance with its quality system. The ATL staff is currently developing additional procedures to adapt this quality system to the testing of space flight hardware in accordance with International Space Station acoustic emission requirements.<

46 CFR 298.11 - Vessel requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... with accepted commercial experience and practice. (g) Metric Usage. Our preferred system of measurement and weights for Vessels and Shipyard Projects is the metric system. ...), classification societies to be ISO 9000 series registered or Quality Systems Certificate Scheme qualified IACS...

46 CFR 298.11 - Vessel requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... with accepted commercial experience and practice. (g) Metric Usage. Our preferred system of measurement and weights for Vessels and Shipyard Projects is the metric system. ...), classification societies to be ISO 9000 series registered or Quality Systems Certificate Scheme qualified IACS...

46 CFR 298.11 - Vessel requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with accepted commercial experience and practice. (g) Metric Usage. Our preferred system of measurement and weights for Vessels and Shipyard Projects is the metric system. ...), classification societies to be ISO 9000 series registered or Quality Systems Certificate Scheme qualified IACS...

46 CFR 298.11 - Vessel requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... with accepted commercial experience and practice. (g) Metric Usage. Our preferred system of measurement and weights for Vessels and Shipyard Projects is the metric system. ...), classification societies to be ISO 9000 series registered or Quality Systems Certificate Scheme qualified IACS...

46 CFR 298.11 - Vessel requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... with accepted commercial experience and practice. (g) Metric Usage. Our preferred system of measurement and weights for Vessels and Shipyard Projects is the metric system. ...), classification societies to be ISO 9000 series registered or Quality Systems Certificate Scheme qualified IACS...

The Pharmaceutical Capping Process-Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force.

PubMed

Mathaes, Roman; Mahler, Hanns-Christian; Vorgrimler, Lothar; Steinberg, Henrik; Dreher, Sascha; Roggo, Yves; Nieto, Alejandra; Brown, Helen; Roehl, Holger; Adler, Michael; Luemkemann, Joerg; Huwyler, Joerg; Lam, Philippe; Stauch, Oliver; Mohl, Silke; Streubel, Alexander

2016-01-01

The majority of parenteral drug products are manufactured in glass vials with an elastomeric rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill-and-finish operations, as it defines the seal quality of the final product. Different critical capping process parameters can affect rubber stopper defects, rubber stopper compression, container closure integrity, and also crimp cap quality. A sufficiently high force to remove the flip-off button prior to usage is required to ensure quality of the drug product unit by the flip-off button during storage, transportation, and until opening and use. Therefore, the final product is 100% visually inspected for lose or defective crimp caps, which is subjective as well as time- and labor-intensive. In this study, we sealed several container closure system configurations with different capping equipment settings (with corresponding residual seal force values) to investigate the torque moment required to turn the crimp cap. A correlation between torque moment and residual seal force has been established. The torque moment was found to be influenced by several parameters, including diameter of the vial head, type of rubber stopper (serum or lyophilized) and type of crimp cap (West(®) or Datwyler(®)). In addition, we measured the force required to remove the flip-off button of a sealed container closure system. The capping process had no influence on measured forces; however, it was possible to detect partially crimped vials. In conclusion, a controlled capping process with a defined target residual seal force range leads to a tight crimp cap on a sealed container closure system and can ensure product quality. The majority of parenteral drug products are manufactured in a glass vials with an elastomeric rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill-and-finish operations, as it defines the seal quality of the final product. An adequate force to remove the flip-off button prior to usage is required to ensure product quality during storage and transportation until use. In addition, the complete crimp cap needs to be fixed in a tight position on the vial. In this study, we investigated the torque moment required to turn the crimp cap and the force required to remove the flip-off button of container closure system sealed with different capping equipment process parameters (having different residual seal force values). © PDA, Inc. 2016.

Design of a Hypermedia-Based Educating System for the Construction of Knowledge

DTIC Science & Technology

1989-09-01

the variety they confront, promote short-term learning . This thesis provides the required background for developing an educating system which promotes...an effective educating system stems frm ever-increasing requirements for learning . Ine Total Quality Management (TQM) program, a Department of Defense...Japan has realized that best efforts ’nly pay off when the workforce is properly educated . Learning has become a pivotal element in the Japanese

Another (Yawn) Revolution.

ERIC Educational Resources Information Center

McDonald, William

1987-01-01

Some of the limitations of desktop publishing are identified including: desktop systems cannot match the finished quality of typeset copy and traditionally prepared graphics; nonpublications office desktop publishing would require more time, and publishing will not be easier; hidden costs; and high quality depends on trained people. (MLW)

Accounting for the costs of quality.

PubMed

Suver, J D; Neumann, B R; Boles, K E

1992-09-01

Total quality management (TQM) represents a paradigm shift in the organizational values that shape every aspect of a healthcare provider's activities. The TQM approach to quality management subscribes to the theory that it is not the work of employees of an organization that leads to poor quality; rather, it is the poor design of systems and procedures. In a book recently published by HFMA, Management Accounting for Healthcare Organizations, third edition, authors Suver, Neumann and Boles point out that the changes in behavioral focus and organizational climate brought about by TQM will have a major impact on management accounting function in healthcare organizations. TQM will require new methods of accounting that will enable the effects of declining quality to be recognized and evaluated. It also will require new types of management accounting reports that will identify opportunities for quality improvement and will monitor the effectiveness of quality management endeavors. The following article has been adapted from the book cited above.

Requirements UML Tool (RUT) Expanded for Extreme Programming (CI02)

NASA Technical Reports Server (NTRS)

McCoy, James R.

2003-01-01

A procedure for capturing and managing system requirements that incorporates XP user stories. Because costs associated with identifying problems in requirements increase dramatically over the lifecycle of a project, a method for identifying sources of software risks in user stories is urgently needed. This initiative aims to determine a set of guide-lines for user stories that will result in high-quality requirement. To further this initiative, a tool is needed to analyze user stories that can assess the quality of individual user stories, detect sources cf software risk's, produce software metrics, and identify areas in user stories that can be improved.

Flight simulator for hypersonic vehicle and a study of NASP handling qualities

NASA Technical Reports Server (NTRS)

Ntuen, Celestine A.; Park, Eui H.; Deeb, Joseph M.; Kim, Jung H.

1992-01-01

The research goal of the Human-Machine Systems Engineering Group was to study the existing handling quality studies in aircraft with sonic to supersonic speeds and power in order to understand information requirements needed for a hypersonic vehicle flight simulator. This goal falls within the NASA task statements: (1) develop flight simulator for hypersonic vehicle; (2) study NASP handling qualities; and (3) study effects of flexibility on handling qualities and on control system performance. Following the above statement of work, the group has developed three research strategies. These are: (1) to study existing handling quality studies and the associated aircraft and develop flight simulation data characterization; (2) to develop a profile for flight simulation data acquisition based on objective statement no. 1 above; and (3) to develop a simulator and an embedded expert system platform which can be used in handling quality experiments for hypersonic aircraft/flight simulation training.

ISO 9001 certification for hospitals in Bulgaria: does it help service?

PubMed

Stoimenova, Assena; Stoilova, Ani; Petrova, Guenka

2014-03-04

The aim of our study is to review the published literature on establishment and implementation of ISO 9001 QMS in European hospitals, to study the availability of International Organization for Standardization (ISO) quality management systems (QMS) in Bulgarian hospitals and to outline the main advantages of ISO implementation in the hospitals in Bulgaria. The information on availability of ISO QMS in the hospitals in Bulgaria was gathered via Bulgarian certification register, the registries of various quality associations, websites of hospitals and certification companies presented in Bulgaria. A total number of 312 hospitals in Bulgaria were screened for the availability of QMS certified against the ISO 9001 requirements. The experience of European hospitals that implemented QMS is positive and the used approaches to improve the processes and the demonstrated effects from ISO implementation are analysed by the researchers. Unlike other European Union member states, the establishment of quality management systems in Bulgaria is not compulsory. However, our study revealed that 14.42% of the hospitals in Bulgaria have implemented and have certified quality systems against the requirements of ISO 9001. Our study confirmed that a quality management system using the ISO 9001 standard is useful for the hospitals as it can help to increase the operational efficiencies, to reduce errors, improve patient safety and produce a more preventive approach instead of a reactive environment.

Modernized build and test infrastructure for control software at ESO: highly flexible building, testing, and automatic quality practices for telescope control software

NASA Astrophysics Data System (ADS)

Pellegrin, F.; Jeram, B.; Haucke, J.; Feyrin, S.

2016-07-01

The paper describes the introduction of a new automatized build and test infrastructure, based on the open-source software Jenkins1, into the ESO Very Large Telescope control software to replace the preexisting in-house solution. A brief introduction to software quality practices is given, a description of the previous solution, the limitations of it and new upcoming requirements. Modifications required to adapt the new system are described, how these were implemented to current software and the results obtained. An overview on how the new system may be used in future projects is also presented.

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...

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...

48 CFR 9.204 - Responsibilities for establishment of a qualification requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... requirements. If active competition on anticipated future qualification requirements is likely to be fewer than... establishing the production, quality control, or other system to be tested and evaluated) for a small business... additional qualified sources or products are likely to result in cost savings from increased competition for...

Analysing the quality of routine malaria data in Mozambique.

PubMed

Chilundo, Baltazar; Sundby, Johanne; Aanestad, Margunn

2004-03-03

In Mozambique, malaria is the principal cause of morbidity and mortality. Efforts are being made to increase control activities within communities. These activities require management decisions based on evidence of malaria incidence. Although some data generated are of poor quality, there is little research towards improving the reporting systems. An analysis of the quality of routine malaria data was performed in selected districts in Southern Mozambique from August to September 2003. The aim was to assess the quality of the source data in terms of completeness, correctness and consistency across management levels. Analysis revealed primary data to be of poor quality. The diversity of reporting systems with limited coordination give rise to redundancies and wastage of resources. There was evidence of "invention" of data in health facilities contributing to an incorrect representation of malaria incidence. Large, "non-clinical", time-based variations of malaria cases due to reporting delays were also noted, contributing to false alerts of outbreaks.Furthermore, targets established in the national strategic plan for malaria cannot be calculated through the existing systems; this is the case, for example, for data related to pregnant women and children under-five years. The existing reporting system for malaria is currently not satisfying the information needs of managers. It is suggested that one standardized system, including the creation of one form to include the essential variables required for the calculation of key indicators by age, gender and pregnancy status, and to establish a national database that maps malaria by location.

Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

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

Komann, Steffen; Groeke, Carsten; Droste, Bernhard

The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment bymore » the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)« less

Automated daily quality control analysis for mammography in a multi-unit imaging center.

PubMed

Sundell, Veli-Matti; Mäkelä, Teemu; Meaney, Alexander; Kaasalainen, Touko; Savolainen, Sauli

2018-01-01

Background The high requirements for mammography image quality necessitate a systematic quality assurance process. Digital imaging allows automation of the image quality analysis, which can potentially improve repeatability and objectivity compared to a visual evaluation made by the users. Purpose To develop an automatic image quality analysis software for daily mammography quality control in a multi-unit imaging center. Material and Methods An automated image quality analysis software using the discrete wavelet transform and multiresolution analysis was developed for the American College of Radiology accreditation phantom. The software was validated by analyzing 60 randomly selected phantom images from six mammography systems and 20 phantom images with different dose levels from one mammography system. The results were compared to a visual analysis made by four reviewers. Additionally, long-term image quality trends of a full-field digital mammography system and a computed radiography mammography system were investigated. Results The automated software produced feature detection levels comparable to visual analysis. The agreement was good in the case of fibers, while the software detected somewhat more microcalcifications and characteristic masses. Long-term follow-up via a quality assurance web portal demonstrated the feasibility of using the software for monitoring the performance of mammography systems in a multi-unit imaging center. Conclusion Automated image quality analysis enables monitoring the performance of digital mammography systems in an efficient, centralized manner.

Requirements for Workflow-Based EHR Systems - Results of a Qualitative Study.

PubMed

Schweitzer, Marco; Lasierra, Nelia; Hoerbst, Alexander

2016-01-01

Today's high quality healthcare delivery strongly relies on efficient electronic health records (EHR). These EHR systems or in general healthcare IT-systems are usually developed in a static manner according to a given workflow. Hence, they are not flexible enough to enable access to EHR data and to execute individual actions within a consultation. This paper reports on requirements pointed by experts in the domain of diabetes mellitus to design a system for supporting dynamic workflows to serve personalization within a medical activity. Requirements were collected by means of expert interviews. These interviews completed a conducted triangulation approach, aimed to gather requirements for workflow-based EHR interactions. The data from the interviews was analyzed through a qualitative approach resulting in a set of requirements enhancing EHR functionality from the user's perspective. Requirements were classified according to four different categorizations: (1) process-related requirements, (2) information needs, (3) required functions, (4) non-functional requirements. Workflow related requirements were identified which should be considered when developing and deploying EHR systems.

The clinical nurse specialist: leadership in quality improvement.

PubMed

Finkelman, Anita

2013-01-01

Healthcare delivery is in a crisis, requiring improvement. How to improve and who should assume more leadership are not clear. At the same time, the nursing profession struggles with a weak education system, graduating students who require major support for an extended time. There is also confusion related to nursing roles, particularly with nurses who have a graduate degree. The Institute of Medicine has published a series of reports about the healthcare system and need for improvement and describes a structure for improvement. The clinical nurse specialist is particularly suited to assume a major role in nursing leadership to guide staff and the healthcare system to better ensure improved care. There is great need to communicate that the clinical nurse specialist can and should assume this role. This will require a review and development of more quality improvement content and experiences in clinical nurse specialist educational programs, but much of the content is already in programs. The clinical nurse specialist works in systems, impacts systems, works with staff, and can thus reach more patients with improvement approaches.

Lab-on-a-chip based total-phosphorus analysis device utilizing a photocatalytic reaction

NASA Astrophysics Data System (ADS)

Jung, Dong Geon; Jung, Daewoong; Kong, Seong Ho

2018-02-01

A lab-on-a-chip (LOC) device for total phosphorus (TP) analysis was fabricated for water quality monitoring. Many commercially available TP analysis systems used to estimate water quality have good sensitivity and accuracy. However, these systems also have many disadvantages such as bulky size, complex pretreatment processes, and high cost, which limit their application. In particular, conventional TP analysis systems require an indispensable pretreatment step, in which the fluidic analyte is heated to 120 °C for 30 min to release the dissolved phosphate, because many phosphates are soluble in water at a standard temperature and pressure. In addition, this pretreatment process requires elevated pressures of up to 1.1 kg cm-2 in order to prevent the evaporation of the heated analyte. Because of these limiting conditions required by the pretreatment processes used in conventional systems, it is difficult to miniaturize TP analysis systems. In this study, we employed a photocatalytic reaction in the pretreatment process. The reaction was carried out by illuminating a photocatalytic titanium dioxide (TiO2) surface formed in a microfluidic channel with ultraviolet (UV) light. This pretreatment process does not require elevated temperatures and pressures. By applying this simplified, photocatalytic-reaction-based pretreatment process to a TP analysis system, greater degrees of freedom are conferred to the design and fabrication of LOC devices for TP monitoring. The fabricated LOC device presented in this paper was characterized by measuring the TP concentration of an unknown sample, and comparing the results with those measured by a conventional TP analysis system. The TP concentrations of the unknown sample measured by the proposed LOC device and the conventional TP analysis system were 0.018 mgP/25 mL and 0.019 mgP/25 mL, respectively. The experimental results revealed that the proposed LOC device had a performance comparable to the conventional bulky TP analysis system. Therefore, our device could be directly employed in water quality monitoring as an alternative to conventional TP analysis systems.

A Methodology for Writing High Quality Requirement Specifications and for Evaluating Existing Ones

NASA Technical Reports Server (NTRS)

Rosenberg, Linda; Hammer, Theodore

1999-01-01

Requirements development and management have always been critical in the implementation of software systems-engineers are unable to build what analysts can not define. It is generally accepted that the earlier in the life cycle potential risks are identified the easier it is to eliminate or manage the conditions that introduce that risk. Problems that are not found until testing are approximately 14 times more costly to fix than if the problem was found in the requirement phase. The requirements specification, as the first tangible representation of the capability to be produced, establishes the basis for all of the project's engineering management and assurance functions. If the quality of the requirements specification is poor it can give rise to risks in all areas of the project. Recently, automated tools have become available to support requirements management. The use of these tools not only provides support in the definition and tracing of requirements, but it also opens the door to effective use of metrics in characterizing and assessing the quality of the requirement specifications.

A Methodology for Writing High Quality Requirements Specification and Evaluating Existing Ones

NASA Technical Reports Server (NTRS)

Rosenberg, Linda; Hammer, Theodore

1999-01-01

Requirements development and management have always been critical in the implementation of software systems; engineers are unable to build what analysts can't define. It is generally accepted that the earlier in the life cycle potential risks are identified the easier it is to eliminate or manage the conditions that introduce that risk. Problems that are not found until testing are approximately 14 times more costly to fix than if the problem was found in the requirement phase. The requirements specification, as the first tangible representation of the capability to be produced, establishes the basis for all of the project's engineering management and assurance functions. If the quality of the requirements specification is poor it can give rise to risks in all areas of the project. Recently, automated tools have become available to support requirements management. The use of these tools not only provides support in the definition and tracing of requirements, but it also opens the door to effective use of metrics in characterizing and assessing the quality of the requirement specifications.

Using Quality Attributes to Bridge Systems Engineering Gaps : A Juno Ground Data Systems Case Study

NASA Technical Reports Server (NTRS)

Dubon, Lydia P.; Jackson, Maddalena M.; Thornton, Marla S.

2012-01-01

The Juno Mission to Jupiter is the second mission selected by the NASA New Frontiers Program. Juno launched August 2011 and will reach Jupiter July 2016. Juno's payload system is composed of nine instruments plus a gravity science experiment. One of the primary functions of the Juno Ground Data System (GDS) is the assembly and distribution of the CFDP (CCSDS File Delivery Protocol) product telemetry, also referred to as raw science data, for eight out of the nine instruments. The GDS accomplishes this with the Instrument Data Pipeline (IDP). During payload integration, the first attempt to exercise the IDP in a flight like manner revealed that although the functional requirements were well understood, the system was unable to meet latency requirements with the as-is heritage design. A systems engineering gap emerged between Juno instrument data delivery requirements and the assumptions behind the heritage flight-ground interactions. This paper describes the use of quality attributes to measure and overcome this gap by introducing a new systems engineering activity, and a new monitoring service architecture that successfully delivered the performance metrics needed to validate Juno IDP.

A Survey on Data Quality for Dependable Monitoring in Wireless Sensor Networks.

PubMed

Jesus, Gonçalo; Casimiro, António; Oliveira, Anabela

2017-09-02

Wireless sensor networks are being increasingly used in several application areas, particularly to collect data and monitor physical processes. Non-functional requirements, like reliability, security or availability, are often important and must be accounted for in the application development. For that purpose, there is a large body of knowledge on dependability techniques for distributed systems, which provide a good basis to understand how to satisfy these non-functional requirements of WSN-based monitoring applications. Given the data-centric nature of monitoring applications, it is of particular importance to ensure that data are reliable or, more generically, that they have the necessary quality. In this survey, we look into the problem of ensuring the desired quality of data for dependable monitoring using WSNs. We take a dependability-oriented perspective, reviewing the possible impairments to dependability and the prominent existing solutions to solve or mitigate these impairments. Despite the variety of components that may form a WSN-based monitoring system, we give particular attention to understanding which faults can affect sensors, how they can affect the quality of the information and how this quality can be improved and quantified.

Roles of laboratories and laboratory systems in effective tuberculosis programmes

PubMed Central

van Deun, Armand; Kam, Kai Man; Narayanan, PR; Aziz, Mohamed Abdul

2007-01-01

Abstract 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. PMID:17639219

Design of a practical model-observer-based image quality assessment method for CT imaging systems

NASA Astrophysics Data System (ADS)

Tseng, Hsin-Wu; Fan, Jiahua; Cao, Guangzhi; Kupinski, Matthew A.; Sainath, Paavana

2014-03-01

The channelized Hotelling observer (CHO) is a powerful method for quantitative image quality evaluations of CT systems and their image reconstruction algorithms. It has recently been used to validate the dose reduction capability of iterative image-reconstruction algorithms implemented on CT imaging systems. The use of the CHO for routine and frequent system evaluations is desirable both for quality assurance evaluations as well as further system optimizations. The use of channels substantially reduces the amount of data required to achieve accurate estimates of observer performance. However, the number of scans required is still large even with the use of channels. This work explores different data reduction schemes and designs a new approach that requires only a few CT scans of a phantom. For this work, the leave-one-out likelihood (LOOL) method developed by Hoffbeck and Landgrebe is studied as an efficient method of estimating the covariance matrices needed to compute CHO performance. Three different kinds of approaches are included in the study: a conventional CHO estimation technique with a large sample size, a conventional technique with fewer samples, and the new LOOL-based approach with fewer samples. The mean value and standard deviation of area under ROC curve (AUC) is estimated by shuffle method. Both simulation and real data results indicate that an 80% data reduction can be achieved without loss of accuracy. This data reduction makes the proposed approach a practical tool for routine CT system assessment.

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...

Sequential air sampler system : its use by the Virginia Department of Highways & Transportation.

DOT National Transportation Integrated Search

1975-01-01

The Department of Highways & Transportation needs an economical and efficient air quality sampling system for meeting requirements on air monitoring for proposed projects located In critical areas. Two sequential air sampling systems, the ERAI and th...

Breathing Easy over Air Quality.

ERIC Educational Resources Information Center

Greim, Clifton; Turner, William

1991-01-01

School systems should test the air in every school building for the presence and level of contaminants such as radon and asbestos and whether the ventilation system is circulating the proper amount of air. Periodic maintenance is required for all mechanical systems. (MLF)

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...

Argo workstation: a key component of operational oceanography

NASA Astrophysics Data System (ADS)

Dong, Mingmei; Xu, Shanshan; Miao, Qingsheng; Yue, Xinyang; Lu, Jiawei; Yang, Yang

2018-02-01

Operational oceanography requires the quantity, quality, and availability of data set and the timeliness and effectiveness of data products. Without steady and strong operational system supporting, operational oceanography will never be proceeded far. In this paper we describe an integrated platform named Argo Workstation. It operates as a data processing and management system, capable of data collection, automatic data quality control, visualized data check, statistical data search and data service. After it is set up, Argo workstation provides global high quality Argo data to users every day timely and effectively. It has not only played a key role in operational oceanography but also set up an example for operational system.

WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

PubMed

2006-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

When Poor Indoor Air Causes a Crisis.

ERIC Educational Resources Information Center

Spencer, Robert D.

1998-01-01

An air quality problem originating with a steam leak in an improperly maintained heating system resulted in unanticipated expenses of $420,000 for the Lakeview (Michigan) School District. Indoor air quality complaints require immediate investigation and action; clear communication to parents, staff, and media representatives; competent…

The Business of Art Education: A Fairytale Adventure

ERIC Educational Resources Information Center

Buda, Sharon; Fedorenko, Jan; Sheridan, Mary A.

2012-01-01

School reform initiatives designed to improve school quality require strong leadership, strategic planning, data analysis, and systemized performance accountability. Utilizing school reforms includes rethinking curriculum and instruction to improve quality and promote equality, restructuring school operations with a focus on both the students and…

40 CFR 265.91 - Ground-water monitoring system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... sufficient to yield ground-water samples that are: (i) Representative of background ground-water quality in... not required provided that provisions for sampling upgradient and downgradient water quality will... perforated, and packed with gravel or sand where necessary, to enable sample collection at depths where...

Factors Influencing Team Performance in a Continuous Quality Improvement Process in the Wisconsin Technical College System

ERIC Educational Resources Information Center

Pietz, Victoria Lynn

2014-01-01

Continuous Quality Improvement (CQI) programs are growing in popularity in higher education settings and a key component is the use of work groups, which require active employee involvement. The problem addressed in this research was the lack of employee engagement in the Quality Review Process (QRP), which is a statewide CQI model developed by…

Quality Assurance in Open and Distance Learning. Knowledge Series. A Topical, Start-Up Guide to Distance Education Practice and Delivery

ERIC Educational Resources Information Center

Kirkpatrick, Denise

2005-01-01

Assuring the quality of education provision is a fundamental aspect of gaining and maintaining credibility for programmes, institutions and national systems of higher education worldwide. Despite a long and generally successful track record, open and distance learning (ODL) is still required to prove that the quality of student learning is at…

[Cross-sectoral quality assurance in ambulatory care].

PubMed

Albrecht, Martin; Loos, Stefan; Otten, Marcus

2013-01-01

Overcoming rigid sectoral segmentation in healthcare has also become a health policy target in quality assurance. With the Act to Enhance Competition in Statutory Health Insurance (GKV-WSG) coming into effect, quality assurance measures are to be designed in a cross-sectoral fashion for in- and outpatient sectors equally. An independent institution is currently mandated to develop specific quality indicators for eleven indications. For three of these operating tests have already been commissioned by the Federal Joint Committee. This article depicts the major results of a feasibility study, including a compliance cost estimate, for the aforementioned indications of cross-sectoral quality assurance (cQA). In conclusion, a number of both practical and conceptual basic challenges are still to be resolved prior to the full implementation of cQA, such as a sufficient specification to activate documentation requirements and an inspection system capable of separating actual quality problems from documentary deficits. So far, a comprehensive cost-utility analysis of cQA has not been provided, in particular with comparison to existing QA systems. In order to optimise cost and utility of cQA an evidence-based approach is required for both the extension of cQA areas and for QA provisions. Copyright © 2013. Published by Elsevier GmbH.

Prototype water reuse system

USGS Publications Warehouse

Lucchetti, G.; Gray, G.A.

1988-01-01

A small-scale water reuse system (150 L/min) was developed to create an environment for observing fish under a variety of temperature regimes. Key concerns of disease control, water quality, temperature control, and efficiency and case of operation were addressed. Northern squawfish (Ptychocheilus oregonensis) were held at loading densities ranging from 0.11 to 0.97 kg/L per minute and at temperatures from 10 to 20°C for 6 months with no disease problems or degradation ofwater quality in the system. The system required little maintenance during 2 years of operation.

Role of a quality management system in improving patient safety - laboratory aspects.

PubMed

Allen, Lynn C

2013-09-01

The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

The Determination of Navy Family Housing Requirements

DTIC Science & Technology

1992-04-01

for greater precision and responsiveness, closer scrutiny of Navy family housing programs, and internal initiatives relating to quality management ...DETERMINATION SYSTEM Overview For almost 20 years, the Navy has used a semiautomated system to project family housing requirements. This process is managed ... Family Housing Management Institute (FHMI) materials, and management specifications maintained by NAVFAC and FACSO. FINDINGS Theory We believe that the

The PSRO hospital review system.

PubMed

Goran, M J; Roberts, J S; Kellogg, M A; Fielding, J; Jessee, W

1975-04-01

The 1972 Social Security amendments contained the landmark Professional Standards Review Organization (PSRO) provisions as well as several sections upgrading existing utilization review (UR) requirements under Medicare and Medicaid. With issuance of the PSRO Program Manual and the recent publication of the new UR regulations, HEW for the first time has brought Medicare and Medicaid hospital review requirements into conformity and made them compatible with and supportive of the PSRO program. This article defines the PSRO hospital review system, describes how the three major components-concurrent review, medical care evaluation studies, and profile analysis-interrelate and provides examples of each of these components. Under utilization review requirements or PSRO, hospitals will be required to implement an integrated system of review designed to assure appropriate utilization practices and improve the quality of care. These aims are to be accomplished through the application of concepts of peer review, the use of norms, criteria, and standards, the identification of deficiencies in the quality, administration, or appropriateness of health care services, and their correction through linkage with programs of continuing medical education. Although PSROs are initially responsible for review in hospitals, they will likely provide the locus for a community-wide system of peer review for all services provided under National Health Insurance.

Bridging existing governance gaps: five evidence-based actions that boards can take to pursue high quality care.

PubMed

Leggat, Sandra G; Balding, Cathy

2017-11-13

Objective To explore the impact of the organisational quality systems on quality of care in Victorian health services. Methods During 2015 a total of 55 focus groups were conducted with more than 350 managers, clinical staff and board members in eight Victorian health services to explore the effectiveness of health service quality systems. A review of the quality and safety goals and strategies outlined in the strategic and operating plans of the participating health services was also undertaken. Results This paper focuses on the data related to the leadership role of health service boards in ensuring safe, high-quality care. The findings suggest that health service boards are not fully meeting their governance accountability to ensure consistently high-quality care. The data uncovered major clinical governance gaps between stated board and executive aspirations for quality and safety and the implementation of these expectations at point of care. These gaps were further compounded by quality system confusion, over-reliance on compliance, and inadequate staff engagement. Conclusion Based on the existing evidence we propose five specific actions boards can take to close the gaps, thereby supporting improved care for all consumers. What is known about this topic? Effective governance is essential for high-quality healthcare delivery. Boards are required to play an active role in their organisation's pursuit of high quality care. What does this paper add? Recent government reports suggest that Australian health service boards are not fully meeting their governance requirements for high quality, safe care delivery, and our research pinpoints key governance gaps. What are the implications for practitioners? Based on our research findings we outline five evidence-based actions for boards to improve their governance of quality care delivery. These actions focus on an organisational strategy for high-quality care, with the chief executive officer held accountable for successful implementation, which is actively guided and monitored by the board.

Progress on quality management in the German health system – a long and winding road

PubMed Central

Breckenkamp, Juergen; Wiskow, Christiane; Laaser, Ulrich

2007-01-01

The interest in quality management in health care has increased in the last decades as the financial crises in most health systems generated the need for solutions to contain costs while maintaining quality of care. In Germany the development of quality management procedures has been closely linked with health care reforms. Starting in the early nineties quality management issues gained momentum in reform legislation only 10 years later. This review summarizes recent developments in medical quality management as related to the federal reform legislation in Germany. It provides an overview on the infrastructure, actors and on the current discussion concerning quality management in medical care. Germany had to catch up on implementing quality management in the health system compared to other countries. Considerable progress has been made, however, it is recognized that the full integration of quality management will require long-term commitment in developing methods, instruments and communication procedures. The most ambitious project at present is the development of a comprehensive comparative quality management system for hospitals at national level, including public reporting. For the time being medical quality management in Germany is dealt with as a technical and professional issue while the aspects of patient orientation and transparency need further advancement. PMID:17550593

Toward an evidence-based system for innovation support for implementing innovations with quality: tools, training, technical assistance, and quality assurance/quality improvement.

PubMed

Wandersman, Abraham; Chien, Victoria H; Katz, Jason

2012-12-01

An individual or organization that sets out to implement an innovation (e.g., a new technology, program, or policy) generally requires support. In the Interactive Systems Framework for Dissemination and Implementation, a Support System should work with Delivery Systems (national, state and/or local entities such as health and human service organizations, community-based organizations, schools) to enhance their capacity for quality implementation of innovations. The literature on the Support System [corrected] has been underresearched and under-developedThis article begins to conceptualize theory, research, and action for an evidence-based system for innovation support (EBSIS). EBSIS describes key priorities for strengthening the science and practice of support. The major goal of EBSIS is to enhance the research and practice of support in order to build capacity in the Delivery System for implementing innovations with quality, and thereby, help the Delivery System achieve outcomes. EBSIS is guided by a logic model that includes four key support components: tools, training, technical assistance, and quality assurance/quality improvement. EBSIS uses the Getting To Outcomes approach to accountability to aid the identification and synthesis of concepts, tools, and evidence for support. We conclude with some discussion of the current status of EBSIS and possible next steps, including the development of collaborative researcher-practitioner-funder-consumer partnerships to accelerate accumulation of knowledge on the Support System.

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.

A Bayesian-based two-stage inexact optimization method for supporting stream water quality management in the Three Gorges Reservoir region.

PubMed

Hu, X H; Li, Y P; Huang, G H; Zhuang, X W; Ding, X W

2016-05-01

In this study, a Bayesian-based two-stage inexact optimization (BTIO) method is developed for supporting water quality management through coupling Bayesian analysis with interval two-stage stochastic programming (ITSP). The BTIO method is capable of addressing uncertainties caused by insufficient inputs in water quality model as well as uncertainties expressed as probabilistic distributions and interval numbers. The BTIO method is applied to a real case of water quality management for the Xiangxi River basin in the Three Gorges Reservoir region to seek optimal water quality management schemes under various uncertainties. Interval solutions for production patterns under a range of probabilistic water quality constraints have been generated. Results obtained demonstrate compromises between the system benefit and the system failure risk due to inherent uncertainties that exist in various system components. Moreover, information about pollutant emission is accomplished, which would help managers to adjust production patterns of regional industry and local policies considering interactions of water quality requirement, economic benefit, and industry structure.

Supportability Technologies for Future Exploration Missions

NASA Technical Reports Server (NTRS)

Watson, Kevin; Thompson, Karen

2007-01-01

Future long-duration human exploration missions will be challenged by resupply limitations and mass and volume constraints. Consequently, it will be essential that the logistics footprint required to support these missions be minimized and that capabilities be provided to make them highly autonomous from a logistics perspective. Strategies to achieve these objectives include broad implementation of commonality and standardization at all hardware levels and across all systems, repair of failed hardware at the lowest possible hardware level, and manufacture of structural and mechanical replacement components as needed. Repair at the lowest hardware levels will require the availability of compact, portable systems for diagnosis of failures in electronic systems and verification of system functionality following repair. Rework systems will be required that enable the removal and replacement of microelectronic components with minimal human intervention to minimize skill requirements and training demand for crews. Materials used in the assembly of electronic systems (e.g. solders, fluxes, conformal coatings) must be compatible with the available repair methods and the spacecraft environment. Manufacturing of replacement parts for structural and mechanical applications will require additive manufacturing systems that can generate near-net-shape parts from the range of engineering alloys employed in the spacecraft structure and in the parts utilized in other surface systems. These additive manufacturing processes will need to be supported by real-time non-destructive evaluation during layer-additive processing for on-the-fly quality control. This will provide capabilities for quality control and may serve as an input for closed-loop process control. Additionally, non-destructive methods should be available for material property determination. These nondestructive evaluation processes should be incorporated with the additive manufacturing process - providing an in-process capability to ensure that material deposited during layer-additive processing meets required material property criteria.

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.

[Recommendations for the control of documents and the establishment of a documentary system].

PubMed

Vinner, E

2013-06-01

The quality management system that must be implemented in a MBL to meet the requirements of the standard NF EN ISO 15189 is based, among other things, on the creation and use by staff of a documentary system approved and updated. This documentary system is constituted by external documents (standards, suppliers' documents...) and internal documents (quality manual, procedures, instructions, technical and quality recordings...). A procedure of the documentary system control must be formalized. The documentary system should be modeled in order to identify the various procedures to be drafted and the incurred risks in the case a document would be missing in this system. Each document must be indexed in a unique way and document management must be carried out rigorously. The use of document management software is a great help to manage the life cycle of documents.

Data Requirements for Oceanic Processes in the Open Ocean, Coastal Zone, and Cryosphere

NASA Technical Reports Server (NTRS)

Nagler, R. G.; Mccandless, S. W., Jr.

1978-01-01

The type of information system that is needed to meet the requirements of ocean, coastal, and polar region users was examined. The requisite qualities of the system are: (1) availability, (2) accessibility, (3) responsiveness, (4) utility, (5) continuity, and (6) NASA participation. The system would not displace existing capabilities, but would have to integrate and expand the capabilities of existing systems and resolve the deficiencies that currently exist in producer-to-user information delivery options.

A Dynamic Image Quality Evaluation of Videofluoroscopy Images: Considerations for Telepractice Applications.

PubMed

Burns, Clare L; Keir, Benjamin; Ward, Elizabeth C; Hill, Anne J; Farrell, Anna; Phillips, Nick; Porter, Linda

2015-08-01

High-quality fluoroscopy images are required for accurate interpretation of videofluoroscopic swallow studies (VFSS) by speech pathologists and radiologists. Consequently, integral to developing any system to conduct VFSS remotely via telepractice is ensuring that the quality of the VFSS images transferred via the telepractice system is optimized. This study evaluates the extent of change observed in image quality when videofluoroscopic images are transmitted from a digital fluoroscopy system to (a) current clinical equipment (KayPentax Digital Swallowing Workstation, and b) four different telepractice system configurations. The telepractice system configurations consisted of either a local C20 or C60 Cisco TelePresence System (codec unit) connected to the digital fluoroscopy system and linked to a second remote C20 or C60 Cisco TelePresence System via a network running at speeds of either 2, 4 or 6 megabits per second (Mbit/s). Image quality was tested using the NEMA XR 21 Phantom, and results demonstrated some loss in spatial resolution, low contrast detectability and temporal resolution for all transferred images when compared to the fluoroscopy source. When using higher capacity codec units and/or the highest bandwidths to support data transmission, image quality transmitted through the telepractice system was found to be comparable if not better than the current clinical system. This study confirms that telepractice systems can be designed to support fluoroscopy image transfer and highlights important considerations when developing telepractice systems for VFSS analysis to ensure high-quality radiological image reproduction.

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

21 CFR 888.5850 - Nonpowered orthopedic traction apparatus and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. (b... from the current good manufacturing practice requirements of the quality system regulation in part 820...

42 CFR 493.1227 - Condition: Histocompatibility.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., and §§ 493.1281 through 493.1299. General Laboratory Systems ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing § 493.1227 Condition: Histocompatibility. If the laboratory provides services in the specialty of...

42 CFR 493.1227 - Condition: Histocompatibility.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., and §§ 493.1281 through 493.1299. General Laboratory Systems ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing § 493.1227 Condition: Histocompatibility. If the laboratory provides services in the specialty of...

Transtech PQI 301 pavement quality indicator device evaluation.

DOT National Transportation Integrated Search

2010-10-01

The PQI 301 Asphalt Density device, developed by Transtech Systems, Inc., was evaluated by MDOT to determine if it could be used in lieu of the currently required nuclear density gauge. Nuclear density gauges require MDOT personnel to have a license,...

15 CFR 287.2 - Definitions. 1

Code of Federal Regulations, 2010 CFR

2010-01-01

... management of product, process or service quality and environmental performance. Sampling means the selection..., process, service, or person's qualifications conforms to specified requirements. Conformity assessment.... Requirements for products, services, systems, and organizations are those defined by law or regulation or by an...

48 CFR 46.105 - Contractor responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Contractor... CONTRACT MANAGEMENT QUALITY ASSURANCE General 46.105 Contractor responsibilities. (a) The contractor is..., and furnishing such information to the Government as required. (b) The contractor may be required to...

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...

14 CFR 234.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGULATIONS AIRLINE SERVICE QUALITY PERFORMANCE REPORTS § 234.1 Purpose. The purpose of this part is to set... system vendors in computerized form, except as otherwise provided, so that information on air carriers' quality of service can be made available to consumers of air transportation. This part also requires that...

14 CFR 234.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGULATIONS AIRLINE SERVICE QUALITY PERFORMANCE REPORTS § 234.1 Purpose. The purpose of this part is to set... system vendors in computerized form, except as otherwise provided, so that information on air carriers' quality of service can be made available to consumers of air transportation. This part also requires that...

14 CFR 234.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGULATIONS AIRLINE SERVICE QUALITY PERFORMANCE REPORTS § 234.1 Purpose. The purpose of this part is to set... system vendors in computerized form, except as otherwise provided, so that information on air carriers' quality of service can be made available to consumers of air transportation. This part also requires that...

14 CFR 234.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGULATIONS AIRLINE SERVICE QUALITY PERFORMANCE REPORTS § 234.1 Purpose. The purpose of this part is to set... system vendors in computerized form, except as otherwise provided, so that information on air carriers' quality of service can be made available to consumers of air transportation. This part also requires that...

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...

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...

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...

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...

40 CFR 63.7535 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

... activities, including, as applicable, calibration checks and required zero and span adjustments. A monitoring...-control periods, or required monitoring system quality assurance or control activities in data averages... data according to this section and the site-specific monitoring plan required by § 63.7505(d). (b) You...

40 CFR 63.7535 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2011 CFR

2011-07-01

... activities, including, as applicable, calibration checks and required zero and span adjustments. A monitoring...-control periods, or required monitoring system quality assurance or control activities in data averages... data according to this section and the site-specific monitoring plan required by § 63.7505(d). (b) You...

Complying with US and European complaint handling requirements.

PubMed

Donawa, M E

1997-09-01

The importance of customer complaints for providing valuable information on the use of medical devices is clearly reflected in United States (US) and European quality system requirements for handling complaints. However, there are significant differences in US and European complaint handling requirements. This article will discuss those differences and methods for ensuring compliance.

Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial.

PubMed

Arab, Lenore; Hahn, Harry; Henry, Judith; Chacko, Sara; Winter, Ashley; Cambou, Mary C

2010-03-01

Screening and tracking subjects and data management in clinical trials require significant investments in manpower that can be reduced through the use of web-based systems. To support a validation trial of various dietary assessment tools that required multiple clinic visits and eight repeats of online assessments, we developed an interactive web-based system to automate all levels of management of a biomarker-based clinical trial. The "Energetics System" was developed to support 1) the work of the study coordinator in recruiting, screening and tracking subject flow, 2) the need of the principal investigator to review study progress, and 3) continuous data analysis. The system was designed to automate web-based self-screening into the trial. It supported scheduling tasks and triggered tailored messaging for late and non-responders. For the investigators, it provided real-time status overviews on all subjects, created electronic case reports, supported data queries and prepared analytic data files. Encryption and multi-level password protection were used to insure data privacy. The system was programmed iteratively and required six months of a web programmer's time along with active team engagement. In this study the enhancement in speed and efficiency of recruitment and quality of data collection as a result of this system outweighed the initial investment. Web-based systems have the potential to streamline the process of recruitment and day-to-day management of clinical trials in addition to improving efficiency and quality. Because of their added value they should be considered for trials of moderate size or complexity. Copyright 2009 Elsevier Inc. All rights reserved.

Design and development of a structural mode control system

NASA Technical Reports Server (NTRS)

1977-01-01

A program was conducted to compile and document some of the existing information about the conceptual design, development, and tests of the B-1 structural mode control system (SMCS) and its impact on ride quality. This report covers the following topics: (1) Rationale of selection of SMCS to meet ride quality criteria versus basic aircraft stiffening. (2) Key considerations in designing an SMCS, including vane geometry, rate and deflection requirements, power required, compensation network design, and fail-safe requirements. (3) Summary of key results of SMCS vane wind tunnel tests. (4) SMCS performance. (5) SMCS design details, including materials, bearings, and actuators. (6) Results of qualification testing of SMCS on the "Iron Bird" flight control simulator, and lab qualification testing of the actuators. (7) Impact of SMCS vanes on engine inlet characteristics from wind tunnel tests.

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.

Integrating Quality Improvement Education into the Nephrology Curricular Milestones Framework and the Clinical Learning Environment Review

PubMed Central

Prince, Lisa K.; Little, Dustin J.; Schexneider, Katherine I.

2017-01-01

The Accreditation Council for Graduate Medical Education requires that trainees show progressive milestone attainment in the practice–based learning and systems–based practice competencies. As part of the Clinical Learning Environment Review, sponsoring hospitals must educate trainees in health care quality improvement, provide them with specialty–specific quality data, and ensure trainee participation in quality improvement activities and committees. Subspecialty–specific quality improvement curricula in nephrology training programs have not been reported, although considerable curricular and assessment material exists for specialty residencies, including tools for assessing trainee and faculty competence. Nephrology–specific didactic material exists to assist nephrology fellows and faculty mentors in designing and implementing quality improvement projects. Nephrology is notable among internal medicine subspecialties for the emphasis placed on adherence to quality thresholds—specifically for chronic RRT shown by the Centers for Medicare and Medicaid Services Quality Incentive Program. We have developed a nephrology-specific curriculum that meets Accreditation Council for Graduate Medical Education and Clinical Learning Environment Review requirements, acknowledges regulatory quality improvement requirements, integrates with ongoing divisional quality improvement activities, and has improved clinical care and the training program. In addition to didactic training in quality improvement, we track trainee compliance with Kidney Disease Improving Global Outcomes CKD and ESRD quality indicators (emphasizing Quality Improvement Program indicators), and fellows collaborate on a yearly multidisciplinary quality improvement project. Over the past 6 years, each fellowship class has, on the basis of a successful quality improvement project, shown milestone achievement in Systems-Based Practice and Practice-Based Learning. Fellow quality improvement projects have improved nephrology clinical care within the institution and introduced new educational and assessment tools to the training program. All have been opportunities for quality improvement scholarship. The curriculum prepares fellows to apply quality improvement principals in independent clinical practice—while showing milestone advancement and divisional compliance with Clinical Learning Environment Review requirements. PMID:28174318

Achieving Continuous Improvement: Theories that Support a System Change.

ERIC Educational Resources Information Center

Armel, Donald

Focusing on improvement is different than focusing on quality, quantity, customer satisfaction, and productivity. This paper discusses Open System Theory, and suggests ways to change large systems. Changing a system (meaning the way all the parts are connected) requires a considerable amount of data gathering and analysis. Choosing the proper…

Quality management of human resources. Providers should begin by focusing on education, performance management, and reward systems.

PubMed

Blair, C S; Fordyce, M; Barney, S M

1993-10-01

For a quality management transformation to occur, a healthcare organization must focus on education and development, performance management, and recognition and reward systems during the first years of implementation. Education and development are perhaps the most important human resource management functions when implementing quality management principles and processes because behavioral changes will be required at all organizational levels. Specific programs that support an organization's quality management effort will vary but should include the conceptual, cultural, and technical aspects of quality management. The essence of quality management is to always satisfy the customer and to continuously improve the services and products the organization offers. The approach to performance management should therefore rely on customer feedback and satisfaction. An organization committed to quality management should base its performance management approach on customer orientation, process improvement, employee involvement, decision making with data, and continuous improvement. Managers and trustees are being challenged to provide innovative recognition and reward systems that reinforce the values and behaviors consistent with quality management. Such systems must also be aligned with the behaviors and outcomes that support the philosophy, mission, and values of the Catholic healthcare ministry. The following components should be considered for a recognition and reward system: base pay, incentives, benefits, and nonmonetary rewards.