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.

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.

Improving Reliability of Spectrum Analysis for Software Quality Requirements Using TCM

NASA Astrophysics Data System (ADS)

Kaiya, Haruhiko; Tanigawa, Masaaki; Suzuki, Shunichi; Sato, Tomonori; Osada, Akira; Kaijiri, Kenji

Quality requirements are scattered over a requirements specification, thus it is hard to measure and trace such quality requirements to validate the specification against stakeholders' needs. We proposed a technique called “spectrum analysis for quality requirements” which enabled analysts to sort a requirements specification to measure and track quality requirements in the specification. In the same way as a spectrum in optics, a quality spectrum of a specification shows a quantitative feature of the specification with respect to quality. Therefore, we can compare a specification of a system to another one with respect to quality. As a result, we can validate such a specification because we can check whether the specification has common quality features and know its specific features against specifications of existing similar systems. However, our first spectrum analysis for quality requirements required a lot of effort and knowledge of a problem domain and it was hard to reuse such knowledge to reduce the effort. We thus introduce domain knowledge called term-characteristic map (TCM) to reuse the knowledge for our quality spectrum analysis. Through several experiments, we evaluate our spectrum analysis, and main finding are as follows. First, we confirmed specifications of similar systems have similar quality spectra. Second, results of spectrum analysis using TCM are objective, i.e., different analysts can generate almost the same spectra when they analyze the same specification.

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.

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

EPA Pesticide Factsheets

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

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

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...

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...

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.

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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...

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

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...

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...

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.

42 CFR 84.256 - Quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

42 CFR 84.256 - Quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

42 CFR 84.256 - Quality control requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

42 CFR 84.256 - Quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

42 CFR 84.256 - Quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

Quality assurance: Importance of systems and standard operating procedures

PubMed Central

Manghani, Kishu

2011-01-01

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

Quality assurance: Importance of systems and standard operating procedures.

PubMed

Manghani, Kishu

2011-01-01

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

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

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

7 CFR 160.11 - Quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Quality Program Provisions for Aeronautical and Space System Contractors

NASA Technical Reports Server (NTRS)

1969-01-01

This publication sets forth quality program requirements for NASA aeronautical and space programs, systems, subsystems, and related services. These requirements provide for the effective operation of a quality program which ensures that quality criteria and requirements are recognized, definitized, and performed satisfactorily.

Quality requirements for reclaimed/recycled water

NASA Technical Reports Server (NTRS)

Janik, Daniel S.; Sauer, Richard L.; Pierson, Duane L.; Thorstenson, Yvonne R.

1987-01-01

Water used during current and previous space missions has been either carried or made aloft. Future human space endeavors will require some form of water reclamation and recycling. There is little experience in the U.S. space program with this technology. Water reclamation and recycling constitute engineering challenges of the broadest nature that will require an intensive research and development effort if this technology is to mature in time for practical use on the proposed U.S. Space Station. In order for this to happen, reclaimed/recycled water specifications will need to be devised to guide engineering development. Present NASA Potable Water Specifications are not applicable to reclaimed or recycled water. Adequate specifications for ensuring the quality of the reclaimed or recycled potable water system is reviewed, limitations of present water specifications are examined, world experience with potable water reclamation/recycling systems and systems analogs is reviewed, and an approach to developing pertinent biomedical water specifications for spacecraft is presented. Space Station water specifications should be designed to ensure the health of all likely spacecraft inhabitants including man, animals, and plants.

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

7 CFR 58.530 - Keeping quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Requirements for Cottage Cheese Bearing Usda Official Identification § 58.530 Keeping quality requirements. Keeping quality...

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

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 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.

78 FR 7816 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations...), DG-1300, ``Quality Assurance Program Requirements (Operations).'' DATES: Submit comments by April 1... CFR Part 50, Appendix B, ``Quality Assurance Criteria for Nuclear power Plants and Fuel Reprocessing...

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...

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.

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 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient air...

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient air...

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient air...

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient air...

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient air...

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.

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.

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.

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...

Assessing Requirements Quality through Requirements Coverage

NASA Technical Reports Server (NTRS)

Rajan, Ajitha; Heimdahl, Mats; Woodham, Kurt

2008-01-01

In model-based development, the development effort is centered around a formal description of the proposed software system the model. This model is derived from some high-level requirements describing the expected behavior of the software. For validation and verification purposes, this model can then be subjected to various types of analysis, for example, completeness and consistency analysis [6], model checking [3], theorem proving [1], and test-case generation [4, 7]. This development paradigm is making rapid inroads in certain industries, e.g., automotive, avionics, space applications, and medical technology. This shift towards model-based development naturally leads to changes in the verification and validation (V&V) process. The model validation problem determining that the model accurately captures the customer's high-level requirements has received little attention and the sufficiency of the validation activities has been largely determined through ad-hoc methods. Since the model serves as the central artifact, its correctness with respect to the users needs is absolutely crucial. In our investigation, we attempt to answer the following two questions with respect to validation (1) Are the requirements sufficiently defined for the system? and (2) How well does the model implement the behaviors specified by the requirements? The second question can be addressed using formal verification. Nevertheless, the size and complexity of many industrial systems make formal verification infeasible even if we have a formal model and formalized requirements. Thus, presently, there is no objective way of answering these two questions. To this end, we propose an approach based on testing that, when given a set of formal requirements, explores the relationship between requirements-based structural test-adequacy coverage and model-based structural test-adequacy coverage. The proposed technique uses requirements coverage metrics defined in [9] on formal high-level software

[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.

A rapid response air quality analysis system for use in projects having stringent quality assurance requirements

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

Bowman, A.W.

1990-04-01

This paper describes an approach to solve air quality problems which frequently occur during iterations of the baseline change process. From a schedule standpoint, it is desirable to perform this evaluation in as short a time as possible while budgetary pressures limit the size of the staff available to do the work. Without a method in place to deal with baseline change proposal requests the environment analysts may not be able to produce the analysis results in the time frame expected. Using a concept called the Rapid Response Air Quality Analysis System (RAAS), the problems of timing and cost becomemore » tractable. The system could be adapted to assess other atmospheric pathway impacts, e.g., acoustics or visibility. The air quality analysis system used to perform the EA analysis (EA) for the Salt Repository Project (part of the Civilian Radioactive Waste Management Program), and later to evaluate the consequences of proposed baseline changes, consists of three components: Emission source data files; Emission rates contained in spreadsheets; Impact assessment model codes. The spreadsheets contain user-written codes (macros) that calculate emission rates from (1) emission source data (e.g., numbers and locations of sources, detailed operating schedules, and source specifications including horsepower, load factor, and duty cycle); (2) emission factors such as those published by the U.S. Environmental Protection Agency, and (3) control efficiencies.« less

Impact of Requirements Quality on Project Success or Failure

NASA Astrophysics Data System (ADS)

Tamai, Tetsuo; Kamata, Mayumi Itakura

We are interested in the relationship between the quality of the requirements specifications for software projects and the subsequent outcome of the projects. To examine this relationship, we investigated 32 projects started and completed between 2003 and 2005 by the software development division of a large company in Tokyo. The company has collected reliable data on requirements specification quality, as evaluated by software quality assurance teams, and overall project performance data relating to cost and time overruns. The data for requirements specification quality were first converted into a multiple-dimensional space, with each dimension corresponding to an item of the recommended structure for software requirements specifications (SRS) defined in IEEE Std. 830-1998. We applied various statistical analysis methods to the SRS quality data and project outcomes.

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.

42 CFR 475.103 - Requirements for performing quality improvement initiatives.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Requirements for performing quality improvement... HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS QUALITY IMPROVEMENT ORGANIZATIONS Quality Improvement Organizations § 475.103 Requirements for performing quality improvement initiatives...

Electronic health records. A systematic review on quality requirements.

PubMed

Hoerbst, A; Ammenwerth, E

2010-01-01

Since the first concepts for electronic health records (EHRs) in the 1990s, the content, structure, and technology of such records were frequently changed and adapted. The basic idea to support and enhance health care stayed the same over time. To reach these goals, it is crucial that EHRs themselves adhere to rigid quality requirements. The present review aims at describing the currently available, mainly non-functional, quality requirements with regard to electronic health records. A combined approach - systematic literature analysis and expert interviews - was used. The literature analysis as well as the expert interviews included sources/experts from different domains such as standards and norms, scientific literature and guidelines, and best practice. The expert interviews were performed by using problem-centric qualitative computer-assisted telephone interviews (CATIs) or face-to-face interviews. All of the data that was obtained was analyzed using qualitative content analysis techniques. In total, more than 1200 requirements were identified of which 203 requirements were also mentioned during the expert interviews. The requirements are organized according to the ISO 9126 and the eEurope 2002 criteria. Categories with the highest number of requirements found include global requirements, (general) functional requirements and data security. The number of non-functional requirements found is by contrast lower. The manuscript gives comprehensive insight into the currently available, primarily non-functional, EHR requirements. To our knowledge, there are no other publications that have holistically reported on this topic. The requirements identified can be used in different ways, e.g. the conceptual design, the development of EHR systems, as a starting point for further refinement or as a basis for the development of specific sets of requirements.

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

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...

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

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

Flight Guidance System Requirements Specification

NASA Technical Reports Server (NTRS)

Miller, Steven P.; Tribble, Alan C.; Carlson, Timothy M.; Danielson, Eric J.

2003-01-01

This report describes a requirements specification written in the RSML-e language for the mode logic of a Flight Guidance System of a typical regional jet aircraft. This model was created as one of the first steps in a five-year project sponsored by the NASA Langley Research Center, Rockwell Collins Inc., and the Critical Systems Research Group of the University of Minnesota to develop new methods and tools to improve the safety of avionics designs. This model will be used to demonstrate the application of a variety of methods and techniques, including safety analysis of system and subsystem requirements, verification of key properties using theorem provers and model checkers, identification of potential sources mode confusion in system designs, partitioning of applications based on the criticality of system hazards, and autogeneration of avionics quality code. While this model is representative of the mode logic of a typical regional jet aircraft, it does not describe an actual or planned product. Several aspects of a full Flight Guidance System, such as recovery from failed sensors, have been omitted, and no claims are made regarding the accuracy or completeness of this specification.

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

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-09

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

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...

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

Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

PubMed Central

HAMZA, Alneil; AHMED-ABAKUR, Eltayib; ABUGROUN, Elsir; BAKHIT, Siham; HOLI, Mohamed

2013-01-01

Background The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre – intervention phase, Intervention phase and Post-intervention phase. Results: In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen’s d) of (0.00) in pre-intervention phase and (0.99) in post – intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure. PMID:23967422

Cost effectiveness of adopted quality requirements in hospital laboratories.

PubMed

Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

2013-01-01

The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

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.

78 FR 37850 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations... Regulatory Commission (NRC) is issuing a revision to Regulatory Guide (RG) 1.33, ``Quality Assurance Program... managerial and administrative Quality Assurance (QA) controls for nuclear power plants during operations...

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.

Requirements for satisfactory flying qualities of airplanes

NASA Technical Reports Server (NTRS)

Gilruth, R R

1943-01-01

Report discusses the results of an analysis of available data to determine what measured characteristics are significant in defining satisfactory flying qualities, what characteristics are reasonable to require of an airplane, and what influence the various design features have on the observed flying qualities.

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...

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.

10 CFR 71.101 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan. The...

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan. The...

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan. The...

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan. The...

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan. The...

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.

40 CFR 64.8 - Quality improvement plan (QIP) requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 16 2014-07-01 2014-07-01 false Quality improvement plan (QIP) requirements. 64.8 Section 64.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) COMPLIANCE ASSURANCE MONITORING § 64.8 Quality improvement plan (QIP) requirements. (a...

40 CFR 64.8 - Quality improvement plan (QIP) requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Quality improvement plan (QIP) requirements. 64.8 Section 64.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) COMPLIANCE ASSURANCE MONITORING § 64.8 Quality improvement plan (QIP) requirements. (a...

Quality Requirements for Teacher Educators

ERIC Educational Resources Information Center

Koster, B.; Brekelmans, M.; Korthagen, F.; Wubbels, T.

2005-01-01

This study deals with the quality requirements that are needed for teacher educators. The tasks teacher educators have to do and the competencies they should possess (a professional profile), according to their fellow teacher educators, were identified. On the basis of a literature search on tasks and competencies of teacher educators, we made a…

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.

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.

Discovering system requirements

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

Bahill, A.T.; Bentz, B.; Dean, F.F.

1996-07-01

Cost and schedule overruns are often caused by poor requirements that are produced by people who do not understand the requirements process. This report provides a high-level overview of the system requirements process, explaining types, sources, and characteristics of good requirements. System requirements, however, are seldom stated by the customer. Therefore, this report shows ways to help you work with your customer to discover the system requirements. It also explains terminology commonly used in the requirements development field, such as verification, validation, technical performance measures, and the various design reviews.

30 CFR 28.30 - Quality control plans; filing requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control plans; filing requirements. 28... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

30 CFR 28.30 - Quality control plans; filing requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control plans; filing requirements. 28... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

30 CFR 28.30 - Quality control plans; filing requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

30 CFR 28.30 - Quality control plans; filing requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

30 CFR 28.30 - Quality control plans; filing requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

User Requirements Analysis For Digital Library Application Using Quality Function Deployment.

NASA Astrophysics Data System (ADS)

Wulandari, Lily; Sularto, Lana; Yusnitasari, Tristyanti; Ikasari, Diana

2017-03-01

This study attemp to build Smart Digital Library to be used by the wider community wherever they are. The system is built in the form of Smart Digital Library portal which uses semantic similarity method (Semantic Similarity) to search journals, articles or books by title or author name. This method is also used to determine the recommended books to be read by visitors of Smart Digital Library based on testimony from a previous reader automatically. Steps being taken in the development of Smart Digital Library system is the analysis phase, design phase, testing and implementation phase. At this stage of the analysis using WebQual for the preparation of the instruments to be distributed to the respondents and the data obtained from the respondents will be processed using Quality Function Deployment. In the analysis phase has the purpose of identifying consumer needs and technical requirements. The analysis was performed to a digital library on the web digital library Gunadarma University, Bogor Institute of Agriculture, University of Indonesia, etc. The questionnaire was distributed to 200 respondents. The research methodology begins with the collection of user requirements and analyse it using QFD. Application design is funded by the government through a program of Featured Universities Research by the Directorate General of Higher Education (DIKTI). Conclusions from this research are identified which include the Consumer Requirements of digital library application. The elements of the consumers requirements consists of 13 elements and 25 elements of Engineering Characteristics digital library requirements. Therefore the design of digital library applications that will be built, is designed according to the findings by eliminating features that are not needed by restaurant based on QFD House of Quality.

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…

Requirements for a Global Greenhouse Gas Information System

NASA Astrophysics Data System (ADS)

Duren, R.; Boland, S.; Lempert, R.; Miller, C.

2008-12-01

A global greenhouse gas information system will prove a critical component of any successful effort to mitigate climate change which relies on limiting the atmospheric concentration of greenhouse gases. The system will provide the situational awareness necessary to actively reduce emissions, influence land use change, and sequester carbon. The information from such a system will be subject to intense scrutiny. Therefore, an effective system must openly and transparently produce data of unassailable quality. A global greenhouse gas information system will likely require a combination of space-and air-based remote- sensing assets, ground-based measurements, carbon cycle modeling and self-reporting. The specific requirements on such a system will be shaped by the degree of international cooperation it enjoys and the needs of the policy regime it aims to support, which might range from verifying treaty obligations, to certifying the tradable permits and offsets underlying a market in greenhouse gas emission reductions, to providing a comprehensive inventory of high and low emitters that could be used by non-governmental organizations and other international actors. While some technical studies have examined particular system components in single scenarios, there remains a need for a comprehensive survey of the range of potential requirements, options, and strategies for the overall system. We have initiated such a survey and recently hosted a workshop which engaged a diverse community of stakeholders to begin synthesizing requirements for such a system, with an initial focus on carbon dioxide. In this paper we describe our plan for completing the definition of the requirements, options, and strategies for a global greenhouse gas monitoring system. We discuss our overall approach and provide a status on the initial requirements synthesis activity.

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.

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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 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.

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.

Managing System of Systems Requirements with a Requirements Screening Group

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

Ronald R. Barden

2012-07-01

Figuring out an effective and efficient way to manage not only your Requirement’s Baseline, but also the development of all your individual requirements during a Program’s/Project’s Conceptual and Development Life Cycle Stages can be both daunting and difficult. This is especially so when you are dealing with a complex and large System of Systems (SoS) Program with potentially thousands and thousands of Top Level Requirements as well as an equal number of lower level System, Subsystem and Configuration Item requirements that need to be managed. This task is made even more overwhelming when you have to add in integration withmore » multiple requirements’ development teams (e.g., Integrated Product Development Teams (IPTs)) and/or numerous System/Subsystem Design Teams. One solution for tackling this difficult activity on a recent large System of Systems Program was to develop and make use of a Requirements Screening Group (RSG). This group is essentially a Team made up of co-chairs from the various Stakeholders with an interest in the Program of record that are enabled and accountable for Requirements Development on the Program/Project. The RSG co-chairs, often with the help of individual support team, work together as a Program Board to monitor, make decisions on, and provide guidance on all Requirements Development activities during the Conceptual and Development Life Cycle Stages of a Program/Project. In addition, the RSG can establish and maintain the Requirements Baseline, monitor and enforce requirements traceability across the entire Program, and work with other elements of the Program/Project to ensure integration and coordination.« less

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...

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.

Display Systems Dynamics Requirements for Flying Qualities

DTIC Science & Technology

1988-05-09

Schidtt. LodI Caser 13a. TYPE OP REPORT 1 &b TIME COVERED 14 DAEO EPOR Ywot.MDay)15. AGEWCUNT Finial Repart IFROM Oct.66o To DeB- 7lse may 9 178 16...e Di Spc Il .AI OF TABLE OF CONTENTS Section Page I INTRODUCTION 1 1 . Motivation and Objectives 1 2. Overview 3 3. Report Organization 4 II MODEL...BASED ANALYSIS FRAMEWORK 5 1 . Optimal Control Model Structure 5 2. OCM-Based Characterization of Flying Qualities 8 III MODELING THE PERCEPTUAL INTERFACE

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.

[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.

78 FR 25445 - Federal Acquisition Regulation; Submission for OMB Review; Quality Assurance Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

...; Submission for OMB Review; Quality Assurance Requirements AGENCY: Department of Defense (DOD), General... collection requirement concerning quality assurance requirements. A notice was published in the Federal... before May 31, 2013. ADDRESSES: Submit comments identified by Information Collection 9000- 0077, Quality...

[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.

[Technological innovations in radiation oncology require specific quality controls].

PubMed

Lenaerts, E; Mathot, M

2014-01-01

During the last decade, the field of radiotherapy has benefited from major technological innovations and continuously improving treatment efficacy, comfort and safety of patients. This mainly concerns the imaging techniques that allow 4D CT scan recording the respiratory phases, on-board imaging on linear accelerators that ensure perfect positioning of the patient for treatment and irradiation techniques that reduce very significantly the duration of treatment sessions without compromising quality of the treatment plan, including IMRT (Intensity Modulated Radiation Therapy) and VMAT (Volumetric Modulated Arc therapy). In this context of rapid technological change, it is the responsibility of medical physicists to regularly and precisely monitor the perfect functioning of new techniques to ensure patient safety. This requires the use of specific quality control equipment best suited to these new techniques. We will briefly describe the measurement system Delta4 used to control individualized treatment plan for each patient treated with VMAT technology.

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.

14 CFR 21.143 - Quality control data requirements; prime manufacturer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control data requirements; prime... describing assigned responsibilities and delegated authority of the quality control organization, together with a chart indicating the functional relationship of the quality control organization to management...

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.

Clinical requirements for closed-loop control systems.

PubMed

Clarke, William L; Renard, Eric

2012-03-01

Closed-loop (CL) therapy systems should be safe, efficacious, and easily manageable for type 1 diabetes mellitus patient use. For the first two clinical requirements, noninferiority and superiority criteria must be determined based on current conventional and intensive therapy outcomes. Current frequencies of hypoglycemia and diabetic ketoacidosis are reviewed and safety expectations for CL therapy systems are proposed. Glycosylated hemoglobin levels lower than current American Diabetes Association recommendations for different age groups are proposed as superiority criteria. Measures of glycemic variability are described and the recording of blood glucose levels as percentages within, above, and below a target range are suggested as reasonable alternatives to sophisticated statistical analyses. It is also suggested that Diabetes Quality of Life and Fear of Hypoglycemia surveys should be used to track psychobehavioral outcomes. Manageability requirements for safe and effective clinical management of CL systems are worth being underscored. The weakest part of the infusion system remains the catheter, which is exposed to variable and under-delivery incidents. Detection methods are needed to warn both the system and the patient about altered insulin delivery, including internal pressure and flow alarms. Glucose monitor sensor accuracy is another requirement; it includes the definition of conditions that lead to capillary glucose measurement, eventually followed by sensor recalibration or replacement. The crucial clinical requirement will be a thorough definition of the situations when the patient needs to move from CL to manual management of insulin delivery, or inversely can switch back to CL after a requested interruption. Instructions about these actions will constitute a major part of the education process of the patients before using CL systems and contribute to the manageability of these systems. © 2012 Diabetes Technology Society.

Medicare and Medicaid programs; CY 2015 Home Health Prospective Payment System rate update; Home Health Quality Reporting Requirements; and survey and enforcement requirements for home health agencies. Final rule.

PubMed

2014-11-06

This final rule updates Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to-face encounter requirement. This rule also implements: Changes to simplify the face-to-face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), and a HH value-based purchasing (HH VBP) model.

5 CFR 531.504 - Level of performance required for quality step increase.

Code of Federal Regulations, 2010 CFR

2010-01-01

... step increase. 531.504 Section 531.504 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PAY UNDER THE GENERAL SCHEDULE Quality Step Increases § 531.504 Level of performance required for quality step increase. A quality step increase shall not be required but may be granted only...

Perioperative Temperature Measurement Considerations Relevant to Reporting Requirements for National Quality Programs Using Data From Anesthesia Information Management Systems.

PubMed

Epstein, Richard H; Dexter, Franklin; Hofer, Ira S; Rodriguez, Luis I; Schwenk, Eric S; Maga, Joni M; Hindman, Bradley J

2018-02-01

Perioperative hypothermia may increase the incidences of wound infection, blood loss, transfusion, and cardiac morbidity. US national quality programs for perioperative normothermia specify the presence of at least 1 "body temperature" ≥35.5°C during the interval from 30 minutes before to 15 minutes after the anesthesia end time. Using data from 4 academic hospitals, we evaluated timing and measurement considerations relevant to the current requirements to guide hospitals wishing to report perioperative temperature measures using electronic data sources. Anesthesia information management system databases from 4 hospitals were queried to obtain intraoperative temperatures and intervals to the anesthesia end time from discontinuation of temperature monitoring, end of surgery, and extubation. Inclusion criteria included age >16 years, use of a tracheal tube or supraglottic airway, and case duration ≥60 minutes. The end-of-case temperature was determined as the maximum intraoperative temperature recorded within 30 minutes before the anesthesia end time (ie, the temperature that would be used for reporting purposes). The fractions of cases with intervals >30 minutes between the last intraoperative temperature and the anesthesia end time were determined. Among the hospitals, averages (binned by quarters) of 34.5% to 59.5% of cases had intraoperative temperature monitoring discontinued >30 minutes before the anesthesia end time. Even if temperature measurement had been continued until extubation, averages of 5.9% to 20.8% of cases would have exceeded the allowed 30-minute window. Averages of 8.9% to 21.3% of cases had end-of-case intraoperative temperatures <35.5°C (ie, a quality measure failure). Because of timing considerations, a substantial fraction of cases would have been ineligible to use the end-of-case intraoperative temperature for national quality program reporting. Thus, retrieval of postanesthesia care unit temperatures would have been necessary. A

42 CFR 412.44 - Medical review requirements: Admissions and quality review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Medical review requirements: Admissions and quality review. 412.44 Section 412.44 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... Capital-Related Costs § 412.44 Medical review requirements: Admissions and quality review. Beginning on...

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…

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.

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

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...

Advanced EVA system design requirements study: EVAS/space station system interface requirements

NASA Technical Reports Server (NTRS)

Woods, T. G.

1985-01-01

The definition of the Extravehicular Activity (EVA) systems interface requirements and accomodations for effective integration of a production EVA capability into the space station are contained. A description of the EVA systems for which the space station must provide the various interfaces and accomodations are provided. The discussion and analyses of the various space station areas in which the EVA interfaces are required and/or from which implications for EVA system design requirements are derived, are included. The rationale is provided for all EVAS mechanical, fluid, electrical, communications, and data system interfaces as well as exterior and interior requirements necessary to facilitate EVA operations. Results of the studies supporting these discussions are presented in the appendix.

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.

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.

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."

Quality requirements for allergen extracts and allergoids for allergen immunotherapy.

PubMed

Zimmer, J; Bonertz, A; Vieths, S

2017-12-01

All allergen products for allergen immunotherapy currently marketed in the European Union are pharmaceutical preparations derived from allergen-containing source materials like pollens, mites and moulds. Especially this natural origin results in particular demands for the regulatory requirements governing allergen products. Furthermore, the development of regulatory requirements is complicated by the so far missing universal link between certain quality parameters, in particular biological potency, on the one hand and clinical efficacy on the other hand. As a consequence, each allergen product for specific immunotherapy has to be assessed individually for its quality, safety and efficacy. At the same time, biological potency of allergen products is most commonly determined using IgE inhibition assays based on human sera relative to product-specific in house references, ruling out full comparability of products from different manufacturers. This review article aims to summarize the current quality requirements for allergen products including the special requirements implemented for control of chemically modified allergen extracts (allergoids). Copyright © 2017 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

Predicting the Overall Spatial Quality of Automotive Audio Systems

NASA Astrophysics Data System (ADS)

Koya, Daisuke

The spatial quality of automotive audio systems is often compromised due to their unideal listening environments. Automotive audio systems need to be developed quickly due to industry demands. A suitable perceptual model could evaluate the spatial quality of automotive audio systems with similar reliability to formal listening tests but take less time. Such a model is developed in this research project by adapting an existing model of spatial quality for automotive audio use. The requirements for the adaptation were investigated in a literature review. A perceptual model called QESTRAL was reviewed, which predicts the overall spatial quality of domestic multichannel audio systems. It was determined that automotive audio systems are likely to be impaired in terms of the spatial attributes that were not considered in developing the QESTRAL model, but metrics are available that might predict these attributes. To establish whether the QESTRAL model in its current form can accurately predict the overall spatial quality of automotive audio systems, MUSHRA listening tests using headphone auralisation with head tracking were conducted to collect results to be compared against predictions by the model. Based on guideline criteria, the model in its current form could not accurately predict the overall spatial quality of automotive audio systems. To improve prediction performance, the QESTRAL model was recalibrated and modified using existing metrics of the model, those that were proposed from the literature review, and newly developed metrics. The most important metrics for predicting the overall spatial quality of automotive audio systems included those that were interaural cross-correlation (IACC) based, relate to localisation of the frontal audio scene, and account for the perceived scene width in front of the listener. Modifying the model for automotive audio systems did not invalidate its use for domestic audio systems. The resulting model predicts the overall spatial

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.

[Compatibility of different quality control systems].

PubMed

Invernizzi, Enrico

2002-01-01

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

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...

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.

[The Scope, Quality and Safety Requirements of Drug Abuse Testing].

PubMed

Küme, Tuncay; Karakükcü, Çiğdem; Pınar, Aslı; Coşkunol, Hakan

2017-01-01

The aim of this review is to inform about the scopes and requirements of drug abuse testing. Drug abuse testing is one of the tools for determination of drug use. It must fulfill the quality and safety requirements in judgmental legal and administrative decisions. Drug abuse testing must fulfill some requirements like selection of the appropriate test matrix, appropriate screening test panel, sampling in detection window, patient consent, identification of the donor, appropriate collection site, sample collection with observation, identification and control of the sample, specimen custody chain in preanalytical phase; analysis in authorized laboratories, specimen validity tests, reliable testing METHODS, strict quality control, two-step analysis in analytical phase; storage of the split specimen, confirmation of the split specimen in the objection, result custody chain, appropriate cut-off concentration, the appropriate interpretation of the result in postanalytical phase. The workflow and analytical processes of drug abuse testing are explained in last regulation of the Department of Medical Laboratory Services, Ministry of Health in Turkey. The clinical physicians have to know and apply the quality and safety requirements in drug abuse testing according to last regulations in Turkey.

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.

Quality management for space systems in ISRO

NASA Astrophysics Data System (ADS)

Satish, S.; Selva Raju, S.; Nanjunda Swamy, T. S.; Kulkarni, P. L.

2009-11-01

In a little over four decades, the Indian Space Program has carved a niche for itself with the unique application driven program oriented towards National development. The end-to-end capability approach of the space projects in the country call for innovative practices and procedures in assuring the quality and reliability of space systems. The System Reliability (SR) efforts initiated at the start of the projects continue during the entire life cycle of the project encompassing design, development, realisation, assembly, testing and integration and during launch. Even after the launch, SR groups participate in the on-orbit evaluation of transponders in communication satellites and camera systems in remote sensing satellites. SR groups play a major role in identification, evaluation and inculcating quality practices in work centres involved in the fabrication of mechanical, electronics and propulsion systems required for Indian Space Research Organization's (ISRO's) launch vehicle and spacecraft projects. Also the reliability analysis activities like prediction, assessment and demonstration as well as de-rating analysis, Failure Mode Effects and Criticality Analysis (FMECA) and worst-case analysis are carried out by SR groups during various stages of project realisation. These activities provide the basis for project management to take appropriate techno-managerial decisions to ensure that the required reliability goals are met. Extensive test facilities catering to the needs of the space program has been set up. A system for consolidating the experience and expertise gained for issue of standards called product assurance specifications to be used in all ISRO centres has also been established.

7 CFR 932.150 - Modified minimum quality requirements for canned green ripe olives.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Modified minimum quality requirements for canned green... (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts... requirements for canned green ripe olives. The minimum quality requirements prescribed in § 932.52 (a)(1) of...

7 CFR 932.150 - Modified minimum quality requirements for canned green ripe olives.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Modified minimum quality requirements for canned green... (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts... requirements for canned green ripe olives. The minimum quality requirements prescribed in § 932.52 (a)(1) of...

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.

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.

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.

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

Integrated propulsion/energy transfer control systems for lift-fan V/STOL aircraft. [reduction of total propulsion system and control system installation requirements

NASA Technical Reports Server (NTRS)

Deckert, W. H.; Rolls, L. S.

1974-01-01

An integrated propulsion/control system for lift-fan transport aircraft is described. System behavior from full-scale experimental and piloted simulator investigations are reported. The lift-fan transport is a promising concept for short-to-medium haul civil transportation and for other missions. The lift-fan transport concept features high cruise airspeed, favorable ride qualities, small perceived noise footprints, high utilization, transportation system flexibility, and adaptability to VTOL, V/STOL, or STOL configurations. The lift-fan transport has high direct operating costs in comparison to conventional aircraft, primarily because of propulsion system and aircraft low-speed control system installation requirements. An integrated lift-fan propulsion system/aircraft low-speed control system that reduces total propulsion system and control system installation requirements is discussed.

Air quality early-warning system for cities in China

NASA Astrophysics Data System (ADS)

Xu, Yunzhen; Yang, Wendong; Wang, Jianzhou

2017-01-01

Air pollution has become a serious issue in many developing countries, especially in China, and could generate adverse effects on human beings. Air quality early-warning systems play an increasingly significant role in regulatory plans that reduce and control emissions of air pollutants and inform the public in advance when harmful air pollution is foreseen. However, building a robust early-warning system that will improve the ability of early-warning is not only a challenge but also a critical issue for the entire society. Relevant research is still poor in China and cannot always satisfy the growing requirements of regulatory planning, despite the issue's significance. Therefore, in this paper, a hybrid air quality early-warning system was successfully developed, composed of forecasting and evaluation. First, a hybrid forecasting model was proposed as an important part of this system based on the theory of "decomposition and ensemble" and combined with the advanced data processing technique, support vector machine, the latest bio-inspired optimization algorithm and the leave-one-out strategy for deciding weights. Afterwards, to intensify the research, fuzzy evaluation was performed, which also plays an indispensable role in the early-warning system. The forecasting model and fuzzy evaluation approaches are complementary. Case studies using daily air pollution concentrations of six air pollutants from three cities in China (i.e., Taiyuan, Harbin and Chongqing) are used as examples to evaluate the efficiency and effectiveness of the developed air quality early-warning system. Experimental results demonstrate that both the accuracy and the effectiveness of the developed system are greatly superior for air quality early warning. Furthermore, the application of forecasting and evaluation enables the informative and effective quantification of future air quality, offering a significant advantage, and can be employed to develop rapid air quality early-warning systems.

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.

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...

The medical director and quality requirements in the dialysis facility.

PubMed

Schiller, Brigitte

2015-03-06

Four decades after the successful implementation of the ESRD program currently providing life-saving dialysis therapy to >430,000 patients, the definitions of and demands for a high-quality program have evolved and increased at the same time. Through substantial technological advances ESRD care improved, with a predominant focus on the technical aspects of care and the introduction of medications such as erythropoiesis-stimulating agents and active vitamin D for anemia and bone disease management. Despite many advances, the size of the program and the increasingly older and multimorbid patient population have contributed to continuing challenges for providing consistently high-quality care. Medicare's Final Rule of the Conditions for Coverage (April 2008) define the medical director of the dialysis center as the leader of the interdisciplinary team and the person ultimately accountable for quality, safety, and care provided in the center. Knowledge and active leadership with a hands-on approach in the quality assessment and performance improvement process (QAPI) is essential for the achievement of high-quality outcomes in dialysis centers. A collaborative approach between the dialysis provider and medical director is required to optimize outcomes and deliver evidence-based quality care. In 2011 the Centers for Medicare & Medicaid Services introduced a pay-for-performance program-the ESRD quality incentive program (QIP)- with yearly varying quality metrics that result in payment reductions in subsequent years when targets are not achieved during the performance period. Success with the QIP requires a clear understanding of the structure, metrics, and scoring methods. Information on achievement and nonachievement is publicly available, both in facilities (through the facility performance score card) and on public websites (including Medicare's Dialysis Facility Compare). By assuming the leadership role in the quality program of dialysis facilities, the medical

Qualities Required from Engineers of the Global Times

NASA Astrophysics Data System (ADS)

Senuma, Takehide

In this paper, the qualities and characteristics required from an engineer who works globally are discussed based on my own experience of a joint research project with a European company. The most important qualities and characteristics are integrity, one‧s own initiative, basic and expert knowledge, creativity, communicative skills and broad world view. Having initiative seems to be especially significant but is a weak point of young engineers in Japan at present. Ways to develop students‧ initiative are discussed in detail from a view point of the engineering education.

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

[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.

Mississippi Quality Step System: QRS Profile. The Child Care Quality Rating System (QRS)Assessment

ERIC Educational Resources Information Center

Child Trends, 2010

2010-01-01

This paper presents a profile of Mississippi's Quality Step System prepared as part of the Child Care Quality Rating System (QRS) Assessment Study. The profile consists of several sections and their corresponding descriptions including: (1) Program Information; (2) Rating Details; (3) Quality Indicators for Center-Based Programs; (4) Application…

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

21 CFR 820.5 - Quality system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality system. 820.5 Section 820.5 Food and Drugs... QUALITY SYSTEM REGULATION General Provisions § 820.5 Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured...

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.

Missouri Quality Rating System: QRS Profile. The Child Care Quality Rating System (QRS) Assessment

ERIC Educational Resources Information Center

Child Trends, 2010

2010-01-01

This paper presents a profile of Missouri's Quality Rating System prepared as part of the Child Care Quality Rating System (QRS) Assessment Study. The profile consists of several sections and their corresponding descriptions including: (1) Program Information; (2) Rating Details; (3) Quality Indicators for Center-Based Programs; (4) Indicators for…

The NOνA Module Factory Quality Assurance System

NASA Astrophysics Data System (ADS)

Smith, Alex; the NOνA Collaboration

The NOνA experiment will measure neutrino oscillations using a long-baseline beam, a ∼220-ton near detector and a ∼14-kiloton far detector. Production of ∼12500 modules to build these detectors is an industrial scale operation requiring careful quality assurance to meet the stringent technical specifications. Unlike a typical industrial operation, this project will use primarily a part time labor force of ∼200 University of Minnesota undergraduate students managed by a small team of full time employees. The quality assurance system is involved in nearly every aspect of the production: assembly, scheduling, training, payroll, materials, machine maintenance, test data, and safety compliance. The quality assurance data collected during the assembly process allows us to quickly identify and correct any problems that arise.

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

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

75 FR 80066 - Quality Control Requirements for Direct Endorsement Lenders; Notice of Proposed Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5380-N-50] Quality Control Requirements... information: Title of Proposal: Quality Control Requirements for Direct Endorsement Lenders. OMB Control... a result, DE lenders will be responsible for conducting quality control on TPO originations of FHA...

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.

Are stipulated requirements for the quality of maternity care complied with?

PubMed

Johansen, Lars T; Pay, Aase Serine Devold; Broen, Lise; Roland, Brit; Øian, Pål

2017-09-19

The Directorate of Health’s national guide Et trygt fødetilbud – kvalitetskrav til fødselsomsorgen [A safe maternity service – requirements regarding the quality of maternity care] was published in December 2010 and was intended to provide a basis for an improved and more predictable maternity service. This article presents data from the maternity institutions on compliance with the quality requirements, including information on selection, fetal monitoring, organisation, staffing and competencies. The information was acquired with the aid of an electronic questionnaire in the period January–May 2015. The form was sent by e-mail to the medical officer in charge at all maternity units in Norway as at 1 January 2015 (n=47). There was a 100 % response to the questionnaire. The criteria for selecting where pregnant women should give birth were stated to be in conformity with the quality requirements. Some maternity institutions failed to describe the areas of responsibilities of doctors and midwives (38.5 % and 15.4 %, respectively). Few institutions recorded whether the midwife was present with the patient during the active phase. Half of the maternity departments (level 2 birth units) reported unfilled doctors’ posts, and a third of the university hospitals/central hospitals (level 1 birth units) reported a severe shortage of locum midwives. Half of the level 2 birth units believed that the quality requirements had resulted in improved training, but reported only a limited degree of interdisciplinary or mandatory instruction. The study reveals that there are several areas in which the health enterprises have procedures that conform to national quality requirements, but where it is still unclear whether they are observed in practice. Areas for improvement relate to routines describing areas of responsibility, availability of personnel resources and staff training.

A Systems Engineering Approach to Quality Assurance for Aerospace Testing

NASA Technical Reports Server (NTRS)

Shepherd, Christena C.

2015-01-01

On the surface, it appears that AS91001 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK)2 that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness.

Motivating medical information system performance by system quality, service quality, and job satisfaction for evidence-based practice.

PubMed

Chang, Ching-Sheng; Chen, Su-Yueh; Lan, Yi-Ting

2012-11-21

No previous studies have addressed the integrated relationships among system quality, service quality, job satisfaction, and system performance; this study attempts to bridge such a gap with evidence-based practice study. The convenience sampling method was applied to the information system users of three hospitals in southern Taiwan. A total of 500 copies of questionnaires were distributed, and 283 returned copies were valid, suggesting a valid response rate of 56.6%. SPSS 17.0 and AMOS 17.0 (structural equation modeling) statistical software packages were used for data analysis and processing. The findings are as follows: System quality has a positive influence on service quality (γ11= 0.55), job satisfaction (γ21= 0.32), and system performance (γ31= 0.47). Service quality (β31= 0.38) and job satisfaction (β32= 0.46) will positively influence system performance. It is thus recommended that the information office of hospitals and developers take enhancement of service quality and user satisfaction into consideration in addition to placing b on system quality and information quality when designing, developing, or purchasing an information system, in order to improve benefits and gain more achievements generated by hospital information systems.

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…

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.

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

A new health system and its quality agenda.

PubMed

Detmer, D E

2001-01-01

This article reviews recent work on healthcare quality, highlights findings and recommendations of the Institute of Medicine (IOM) reports on medical errors and quality, and describes response to the reports to date. In it, Detmer, chair of the IOM's Board of Health Care Services and a member of its Committee on Quality of Health Care in America, identifies implications of the reports for healthcare delivery organizations and professionals and outlines ways organizations and professionals can improve the six dimensions of patient quality defined by the IOM. Sustained efforts at the point of care and in policy development are needed to overcome cultural inertia, realign incentives, support innovation, and address technical and human resource issues. Success requires that healthcare executives embrace the goal of transforming the healthcare sector into a true system and provide leadership for their organizations and communities in this most fundamental of challenges for twenty-first century healthcare.

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

PubMed

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

2013-02-01

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

Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis

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

MULKEY, C.H.

1999-07-02

This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for themore » Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements.« less

Requirements for guidelines systems: implementation challenges and lessons from existing software-engineering efforts.

PubMed

Shah, Hemant; Allard, Raymond D; Enberg, Robert; Krishnan, Ganesh; Williams, Patricia; Nadkarni, Prakash M

2012-03-09

A large body of work in the clinical guidelines field has identified requirements for guideline systems, but there are formidable challenges in translating such requirements into production-quality systems that can be used in routine patient care. Detailed analysis of requirements from an implementation perspective can be useful in helping define sub-requirements to the point where they are implementable. Further, additional requirements emerge as a result of such analysis. During such an analysis, study of examples of existing, software-engineering efforts in non-biomedical fields can provide useful signposts to the implementer of a clinical guideline system. In addition to requirements described by guideline-system authors, comparative reviews of such systems, and publications discussing information needs for guideline systems and clinical decision support systems in general, we have incorporated additional requirements related to production-system robustness and functionality from publications in the business workflow domain, in addition to drawing on our own experience in the development of the Proteus guideline system (http://proteme.org). The sub-requirements are discussed by conveniently grouping them into the categories used by the review of Isern and Moreno 2008. We cite previous work under each category and then provide sub-requirements under each category, and provide example of similar work in software-engineering efforts that have addressed a similar problem in a non-biomedical context. When analyzing requirements from the implementation viewpoint, knowledge of successes and failures in related software-engineering efforts can guide implementers in the choice of effective design and development strategies.

Requirements for guidelines systems: implementation challenges and lessons from existing software-engineering efforts

PubMed Central

2012-01-01

Background A large body of work in the clinical guidelines field has identified requirements for guideline systems, but there are formidable challenges in translating such requirements into production-quality systems that can be used in routine patient care. Detailed analysis of requirements from an implementation perspective can be useful in helping define sub-requirements to the point where they are implementable. Further, additional requirements emerge as a result of such analysis. During such an analysis, study of examples of existing, software-engineering efforts in non-biomedical fields can provide useful signposts to the implementer of a clinical guideline system. Methods In addition to requirements described by guideline-system authors, comparative reviews of such systems, and publications discussing information needs for guideline systems and clinical decision support systems in general, we have incorporated additional requirements related to production-system robustness and functionality from publications in the business workflow domain, in addition to drawing on our own experience in the development of the Proteus guideline system (http://proteme.org). Results The sub-requirements are discussed by conveniently grouping them into the categories used by the review of Isern and Moreno 2008. We cite previous work under each category and then provide sub-requirements under each category, and provide example of similar work in software-engineering efforts that have addressed a similar problem in a non-biomedical context. Conclusions When analyzing requirements from the implementation viewpoint, knowledge of successes and failures in related software-engineering efforts can guide implementers in the choice of effective design and development strategies. PMID:22405400

Motivating medical information system performance by system quality, service quality, and job satisfaction for evidence-based practice

PubMed Central

2012-01-01

Background No previous studies have addressed the integrated relationships among system quality, service quality, job satisfaction, and system performance; this study attempts to bridge such a gap with evidence-based practice study. Methods The convenience sampling method was applied to the information system users of three hospitals in southern Taiwan. A total of 500 copies of questionnaires were distributed, and 283 returned copies were valid, suggesting a valid response rate of 56.6%. SPSS 17.0 and AMOS 17.0 (structural equation modeling) statistical software packages were used for data analysis and processing. Results The findings are as follows: System quality has a positive influence on service quality (γ11= 0.55), job satisfaction (γ21= 0.32), and system performance (γ31= 0.47). Service quality (β31= 0.38) and job satisfaction (β32= 0.46) will positively influence system performance. Conclusions It is thus recommended that the information office of hospitals and developers take enhancement of service quality and user satisfaction into consideration in addition to placing b on system quality and information quality when designing, developing, or purchasing an information system, in order to improve benefits and gain more achievements generated by hospital information systems. PMID:23171394

A case study of translating ACGME practice-based learning and improvement requirements into reality: systems quality improvement projects as the key component to a comprehensive curriculum.

PubMed

Tomolo, A M; Lawrence, R H; Aron, D C

2009-10-01

In 2002, the Accreditation Council for Graduate Medical Education (ACGME) introduced a new requirement: residents must demonstrate competency in Practice-Based Learning and Improvement (PBLI). Training in this domain is still not consistently integrated into programmes, with few, if any, adequately going beyond knowledge of basic content and addressing all components of the requirement. To summarise the implementation of a PBLI curriculum designed to address all components of the requirement and to evaluate the impact on the practice system. A case-study approach was used for identifying and evaluating the steps for delivering the curriculum, along with the Model for Improvement's successive Plan-Do-Study-Act (PDSA) cycles (July 2004-May 2006). Notes from curriculum development meetings, notes and presentation slides made by teams about their projects, resident curriculum exit evaluations curriculum and interviews. Residents reported high levels of comfort by applying PBLI-related knowledge and skills and that the curriculum improved their ability to do various PBLI tasks. The involvement of multiple stakeholders increased. Twelve of the 15 teams' suggestions with practical systems-relevant outcomes were implemented and sustained beyond residents' project periods. While using the traditional PDSA cycles was helpful, there were limitations. A PBLI curriculum that is centred around practice-based quality improvement projects can fulfil the objectives of this ACGME competency while accomplishing sustained outcomes in quality improvement. A comprehensive curriculum is an investment but offers organisational rewards. We propose a more realistic and informative representation of rapid PDSA cycle changes.

A case study of translating ACGME practice-based learning and improvement requirements into reality: systems quality improvement projects as the key component to a comprehensive curriculum.

PubMed

Tomolo, A M; Lawrence, R H; Aron, D C

2009-06-01

In 2002, the Accreditation Council for Graduate Medical Education (ACGME) introduced a new requirement: residents must demonstrate competency in Practice-Based Learning and Improvement (PBLI). Training in this domain is still not consistently integrated into programmes, with few, if any, adequately going beyond knowledge of basic content and addressing all components of the requirement. To summarise the implementation of a PBLI curriculum designed to address all components of the requirement and to evaluate the impact on the practice system. A case-study approach was used for identifying and evaluating the steps for delivering the curriculum, along with the Model for Improvement's successive Plan-Do-Study-Act (PDSA) cycles (July 2004-May 2006). Notes from curriculum development meetings, notes and presentation slides made by teams about their projects, resident curriculum exit evaluations curriculum and interviews. Residents reported high levels of comfort by applying PBLI-related knowledge and skills and that the curriculum improved their ability to do various PBLI tasks. The involvement of multiple stakeholders increased. Twelve of the 15 teams' suggestions with practical systems-relevant outcomes were implemented and sustained beyond residents' project periods. While using the traditional PDSA cycles was helpful, there were limitations. A PBLI curriculum that is centred around practice-based quality improvement projects can fulfil the objectives of this ACGME competency while accomplishing sustained outcomes in quality improvement. A comprehensive curriculum is an investment but offers organisational rewards. We propose a more realistic and informative representation of rapid PDSA cycle changes.

Exploring Propulsion System Requirements for More and All-Electric Helicopters

NASA Technical Reports Server (NTRS)

Snyder, Christopher A.

2015-01-01

Helicopters offer unique capabilities that are important for certain missions. More and all-electric propulsion systems for helicopters offer the potential for improved efficiency, reliability, vehicle and mission capabilities as well as reduced harmful emissions. To achieve these propulsion system-based benefits, the relevant requirements must be understood and developed for the various component, sub-component and ancillary systems of the overall propulsion system. Three representative helicopters were used to explore propulsion and overall vehicle and mission requirements. These vehicles varied from light utility (one to three occupants) to highly capable (three crew members plus ten passengers and cargo). Assuming 15 and 30 year technology availability, analytical models for electric system components were developed to understand component and ancillary requirements. Overall propulsion system characteristics were developed and used for vehicle sizing and mission analyses to understand the tradeoffs of component performance and weight, with increase in vehicle size and mission capability. Study results indicate that only the light utility vehicle retained significant payload for an arbitrary 100 nautical mile range assuming 15 year technology. Thirty year technology assumptions for battery energy storage are sufficient to enable some range and payload capabilities, but further improvements in energy density are required to maintain or exceed payload and range capabilities versus present systems. Hydrocarbon-fueled range extenders can be prudently used to recover range and payload deficiencies resulting from battery energy density limitations. Thermal loads for electric systems are low heat quality, but seem manageable. To realize the benefits from more and all-electric systems, technology goals must be achieved, as well as vehicles, missions and systems identified that are best suited to take advantage of their unique characteristics.

Exploring Propulsion System Requirements for More and All-Electric Helicopters

NASA Technical Reports Server (NTRS)

Snyder, Christopher A.

2015-01-01

Helicopters offer unique capabilities that are important for certain missions. More and all-electric propulsion systems for helicopters offer the potential for improved efficiency, reliability, vehicle and mission capabilities as well as reduced harmful emissions. To achieve these propulsion system-based benefits, the relevant requirements must be understood and developed for the various component, sub-component and ancillary systems of the overall propulsion system. Three representative helicopters were used to explore propulsion and overall vehicle and mission requirements. These vehicles varied from light utility (one to three occupants) to highly capable (three crew members plus ten passengers and cargo). Assuming 15 and 30 year technology availability, analytical models for electric system components were developed to understand component and ancillary requirements. Overall propulsion system characteristics were developed and used for vehicle sizing and mission analyses to understand the tradeoffs of component performance and weight, with increase in vehicle size and mission capability. Study results indicate that only the light utility vehicle retained significant payload for an arbitrary 100 nautical mile range assuming 15 year technology. Thirty year technology assumptions for battery energy storage are sufficient to enable some range and payload capabilities, but further improvements in energy density are required to maintain or exceed payload and range capabilities versus present systems. Hydrocarbon-fueled range extenders can be prudently used to recover range and payload deficiencies resulting from battery energy density limitations. Thermal loads for electric systems are low heat quality, but seem manageable. To realize the benefits from more and all-electric systems, technology goals must be achieved, as well as identify vehicles, missions and systems that are best suited to take advantage of their unique characteristics.

76 FR 23615 - Notice of Submission of Proposed Information Collection to OMB; Quality Control Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... Proposed Information Collection to OMB; Quality Control Requirements for Direct Endorsement Lenders AGENCY... lists the following information: Title of Proposal: Quality Control Requirements for Direct Endorsement... meet FHA's quality control requirements in light of recent changes to lender eligibility criteria for...

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...

New Hampshire Quality Rating System: QRS Profile. The Child Care Quality Rating System (QRS) Assessment

ERIC Educational Resources Information Center

Child Trends, 2010

2010-01-01

This paper presents a profile of New Hampshire's Quality Rating System prepared as part of the Child Care Quality Rating System (QRS) Assessment Study. The profile consists of several sections and their corresponding descriptions including: (1) Program Information; (2) Rating Details; (3) Quality Indicators for Center-Based Programs; (4)…

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.

EPA National Quality System Contacts

EPA Pesticide Factsheets

Web links and contacts for the individual quality systems developed in support of the EPA Quality System by each EPA Regional Office, National Program Office and ORD National Research Laboratory and Center.

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.

[Colonoscopy quality control as a requirement of colorectal cancer screening].

PubMed

Quintero, Enrique; Alarcón-Fernández, Onofre; Jover, Rodrigo

2013-11-01

The strategies used in population-based colorectal screening strategies culminate in colonoscopy and consequently the success of these programs largely depends on the quality of this diagnostic test. The main factors to consider when evaluating quality are scientific-technical quality, safety, patient satisfaction, and accessibility. Quality indicators allow variability among hospitals, endoscopy units and endoscopists to be determined and can identify those not achieving recommended standards. In Spain, the working group for colonoscopy quality of the Spanish Society of Gastroenterology and the Spanish Society of Gastrointestinal Endoscopy have recently drawn up a Clinical Practice Guideline that contains the available evidence on the quality of screening colonoscopy, as well as the basic requirements that must be met by endoscopy units and endoscopists carrying out this procedure. The implementation of training programs and screening colonoscopy quality controls are strongly recommended to guarantee the success of population-based colorectal cancer screening. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

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.

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.

21 CFR 820.186 - Quality system record.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality system record. 820.186 Section 820.186...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.186 Quality system record. Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and...

OVERVIEW OF EPA'S QUALITY REQUIREMENTS FOR SOLICITATIONS AND CONTRACTS

EPA Science Inventory

The purpose of this presentation and this Website is to assist EPA employees to determine the type of Quality Assurance (QA) requirements needed for work under contract. Most environmental data are collected on behalf of EPA by other organizations. EPA has made available this ea...

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

Special requirements for electronic health record systems in ophthalmology.

PubMed

Chiang, Michael F; Boland, Michael V; Brewer, Allen; Epley, K David; Horton, Mark B; Lim, Michele C; McCannel, Colin A; Patel, Sayjal J; Silverstone, David E; Wedemeyer, Linda; Lum, Flora

2011-08-01

The field of ophthalmology has a number of unique features compared with other medical and surgical specialties regarding clinical workflow and data management. This has important implications for the design of electronic health record (EHR) systems that can be used intuitively and efficiently by ophthalmologists and that can promote improved quality of care. Ophthalmologists often lament the absence of these specialty-specific features in EHRs, particularly in systems that were developed originally for primary care physicians or other medical specialists. The purpose of this article is to summarize the special requirements of EHRs that are important for ophthalmology. The hope is that this will help ophthalmologists to identify important features when searching for EHR systems, to stimulate vendors to recognize and incorporate these functions into systems, and to assist federal agencies to develop future guidelines regarding meaningful use of EHRs. More broadly, the American Academy of Ophthalmology believes that these functions are elements of good system design that will improve access to relevant information at the point of care between the ophthalmologist and the patient, will enhance timely communications between primary care providers and ophthalmologists, will mitigate risk, and ultimately will improve the ability of physicians to deliver the highest-quality medical care. Proprietary or commercial interest disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Teleoperators - Manual/automatic system requirements.

NASA Technical Reports Server (NTRS)

Janow, C.; Malone, T. B.

1973-01-01

The teleoperator is defined as a remotely controlled, cybernetic, man-machine system designed to extend and augment man's sensory, manipulative, and cognitive capabilities. The teleoperator system incorporates the decision making, adaptive intelligence without requiring its presence. The man and the machine work as a team, each contributing unique and significant capabilities, and each depending on the other to achieve a common goal. Some of the more significant requirements associated with the development of teleoperator systems technology for space, industry, and medicine are examined. Emphasis is placed on the requirement to more effectively use the man and the machine in any man-machine system.

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...

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...

[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.

[Document management systems to support quality management systems at university hospitals - an interview-based study].

PubMed

Holderried, Martin; Bökel, Ann-Catrin; Ochsmann, Elke

2018-05-01

In order to save and control the processes and quality of medical services, a suitable steering system of all relevant documents is essential from the point of view of clinical quality management. Systems supporting an automated steering system of documents are called document management systems (DMS), and they also enter the healthcare sector. The use of DMS in the German healthcare sector has hardly been investigated so far. To close this knowledge gap, interviews were carried out with German university hospitals over a six-month period and subjected to a qualitative content analysis according to Mayring. In total, 25 university hospitals agreed to participate in this study, 19 of which have been working with a digital DMS for about six years on average. There was a great variety among the IT systems used. Document management and usability of the DMS as well as its integration into existing IT structures were key decision-making criteria for the selection of a digital DMS. In general, the long-term usability of the DMS is supported by regular evaluation of one's own requirements for the system, administration and training programs. In addition, DMS have a positive effect on patient safety and the quality of medical care. Copyright © 2018. Published by Elsevier GmbH.

Documenting an ISO 9000 Quality System.

ERIC Educational Resources Information Center

Fisher, Barry

1995-01-01

Discusses six steps to follow when documenting an ISO 9000 quality system: using ISO 9000 to develop a quality system, identifying a company's business processes, analyzing the business processes; describing the procedures, writing the quality manual, and working to the documented procedures. (SR)

Iowa Child Care Quality Rating System: QRS Profile. The Child Care Quality Rating System (QRS) Assessment

ERIC Educational Resources Information Center

Child Trends, 2010

2010-01-01

This paper presents a profile of Iowa's Child Care Quality Rating System prepared as part of the Child Care Quality Rating System (QRS) Assessment Study. The profile is divided into the following categories: (1) Program Information; (2) Rating Details; (3) Quality Indicators for Center-Based Programs; (4) Indicators for Family Child Care Programs;…

42 CFR 460.134 - Minimum requirements for quality assessment and performance improvement program.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) Quality of life of participants. (4) Effectiveness and safety of staff-provided and contracted services... 42 Public Health 4 2012-10-01 2012-10-01 false Minimum requirements for quality assessment and... ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Quality Assessment and Performance...

42 CFR 460.134 - Minimum requirements for quality assessment and performance improvement program.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) Quality of life of participants. (4) Effectiveness and safety of staff-provided and contracted services... 42 Public Health 4 2011-10-01 2011-10-01 false Minimum requirements for quality assessment and... ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Quality Assessment and Performance...

42 CFR 460.134 - Minimum requirements for quality assessment and performance improvement program.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Quality of life of participants. (4) Effectiveness and safety of staff-provided and contracted services... 42 Public Health 4 2010-10-01 2010-10-01 false Minimum requirements for quality assessment and... ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Quality Assessment and Performance...

42 CFR 460.134 - Minimum requirements for quality assessment and performance improvement program.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Quality of life of participants. (4) Effectiveness and safety of staff-provided and contracted services... 42 Public Health 4 2013-10-01 2013-10-01 false Minimum requirements for quality assessment and... ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Quality Assessment and Performance...

42 CFR 460.134 - Minimum requirements for quality assessment and performance improvement program.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Quality of life of participants. (4) Effectiveness and safety of staff-provided and contracted services... 42 Public Health 4 2014-10-01 2014-10-01 false Minimum requirements for quality assessment and... ELDERLY (PACE) PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE) Quality Assessment and Performance...

[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.

Quality Management in Astronomical Software and Data Systems

NASA Astrophysics Data System (ADS)

Radziwill, N. M.

2007-10-01

As the demand for more sophisticated facilities increases, the complexity of the technical and organizational challenges faced by operational space- and ground-based telescopes also increases. In many organizations, funding tends not to be proportional to this trend, and steps must be taken to cultivate a lean environment in both development and operations to consistently do more with less. To facilitate this transition, an organization must be aware of how it can meet quality-related goals, such as reducing variation, improving productivity of people and systems, streamlining processes, ensuring compliance with requirements (scientific, organizational, project, or regulatory), and increasing user satisfaction. Several organizations are already on this path. Quality-based techniques for the efficient, effective development of new telescope facilities and maintenance of existing facilities are described.

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.

Advanced EVA system design requirements study

NASA Technical Reports Server (NTRS)

1986-01-01

Design requirements and criteria for the Space Station Advanced Extravehicular Activity System (EVAS) including crew enclosures, portable life support systems, maneuvering propulsion systems, and related extravehicular activity (EVA) support equipment were defined and established. The EVA mission requirements, environments, and medical and physiological requirements, as well as opertional, procedures, and training issues were considered.

Systems Engineering, Quality and Testing

NASA Technical Reports Server (NTRS)

Shepherd, Christena C.

2015-01-01

AS9100 has little to say about how to apply a Quality Management System (QMS) to aerospace test programs. There is little in the quality engineering Body of Knowledge that applies to testing, unless it is nondestructive examination or some type of lab or bench testing. If one examines how the systems engineering processes are implemented throughout a test program; and how these processes can be mapped to AS9100, a number of areas for involvement of the quality professional are revealed.

Improved Traceability of Mission Concept to Requirements Using Model Based Systems Engineering

NASA Technical Reports Server (NTRS)

Reil, Robin

2014-01-01

Model Based Systems Engineering (MBSE) has recently been gaining significant support as a means to improve the traditional document-based systems engineering (DBSE) approach to engineering complex systems. In the spacecraft design domain, there are many perceived and propose benefits of an MBSE approach, but little analysis has been presented to determine the tangible benefits of such an approach (e.g. time and cost saved, increased product quality). This thesis presents direct examples of how developing a small satellite system model can improve traceability of the mission concept to its requirements. A comparison of the processes and approaches for MBSE and DBSE is made using the NASA Ames Research Center SporeSat CubeSat mission as a case study. A model of the SporeSat mission is built using the Systems Modeling Language standard and No Magics MagicDraw modeling tool. The model incorporates mission concept and requirement information from the missions original DBSE design efforts. Active dependency relationships are modeled to analyze the completeness and consistency of the requirements to the mission concept. Overall experience and methodology are presented for both the MBSE and original DBSE design efforts of SporeSat.

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.

30 CFR 74.9 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Physician Quality Reporting System (PQRS) for Interventional Pain Management Practices: Challenges and Opportunities.

PubMed

Manchikanti, Laxmaiah; Hammer, Marvel; Benyamin, Ramsin M; Hirsch, Joshua A

2016-01-01

Basing their rationale on multiple publications from Institute of Medicine (IOM), specifically Crossing the Quality Chasm, policy makers have focused on a broad range of issues, including assessment of the influence of medical practice organization structures on quality performance and development of quality measures. The 2006 Tax Relief and Health Care Act established the Physician Quality Reporting System (PQRS), to enable eligible professionals to report health care quality and health outcome information that cannot be obtained from standard Medicare claims. However, the Patient Protection and Affordable Care Act (ACA) of 2010 required the Centers for Medicare and Medicaid Services (CMS) to incorporate a combination of cost and quality into the payment systems for health care as a precursor to value-based payments. The final change to PQRS pending initiation after 2018, is based on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) which has incorporated alternative payment models and merit-based payment systems. Recent publication of quality performance scores by CMS has been less than optimal. When voluntary participation began in July 2007, providers were paid a bonus for reporting quality measures from 2008 through 2014, ranging from 0.5% to 2% of the Medicare Part B allowed charges furnished during the reporting period. Starting in 2015, penalties started for nonparticipation. Eligible professionals and group practices that failed to satisfactorily report data on quality measures during 2014 are subject to a 2% reduction in Medicare fee-for-service amounts for services furnished by the eligible professional or group practice during 2016. The CMS proposed rule for 2016 physician payments contained a number of provisions with proposed updates to the PQRS and Physician Value-Based Payment Modifier among other changes. The proposed rule is the first release since MACRA repealed the sustainable growth rate formula. CMS proposed to continue many

Maintainability Program Requirements for Space Systems

NASA Technical Reports Server (NTRS)

1987-01-01

This document is established to provide common general requirements for all NASA programs to: design maintainability into all systems where maintenance is a factor in system operation and mission success; and ensure that maintainability characteristics are developed through the systems engineering process. These requirements are not new. Design for ease of maintenance and minimization of repair time have always been fundamental requirements of the systems engineering process. However, new or reusable orbital manned and in-flight maintainable unmanned space systems demand special emphasis on maintainability, and this document has been prepared to meet that need. Maintainability requirements on many NASA programs differ in phasing and task emphasis from requirements promulgated by other Government agencies. This difference is due to the research and development nature of NASA programs where quantities produced are generally small; therefore, the depth of logistics support typical of many programs is generally not warranted. The cost of excessive maintenance is very high due to the logistics problems associated with the space environment. The ability to provide timely maintenance often involves safety considerations for manned space flight applications. This document represents a basic set of requirements that will achieve a design for maintenance. These requirements are directed primarily at manned and unmanned orbital space systems. To be effective, maintainability requirements should be tailored to meet specific NASA program and project needs and constraints. NASA activities shall invoke the requirements of this document consistent with program planning in procurements or on inhouse development efforts.

Calibration Issues and Operating System Requirements for Electron-Probe Microanalysis

NASA Technical Reports Server (NTRS)

Carpenter, P.

2006-01-01

Instrument purchase requirements and dialogue with manufacturers have established hardware parameters for alignment, stability, and reproducibility, which have helped improve the precision and accuracy of electron microprobe analysis (EPMA). The development of correction algorithms and the accurate solution to quantitative analysis problems requires the minimization of systematic errors and relies on internally consistent data sets. Improved hardware and computer systems have resulted in better automation of vacuum systems, stage and wavelength-dispersive spectrometer (WDS) mechanisms, and x-ray detector systems which have improved instrument stability and precision. Improved software now allows extended automated runs involving diverse setups and better integrates digital imaging and quantitative analysis. However, instrumental performance is not regularly maintained, as WDS are aligned and calibrated during installation but few laboratories appear to check and maintain this calibration. In particular, detector deadtime (DT) data is typically assumed rather than measured, due primarily to the difficulty and inconvenience of the measurement process. This is a source of fundamental systematic error in many microprobe laboratories and is unknown to the analyst, as the magnitude of DT correction is not listed in output by microprobe operating systems. The analyst must remain vigilant to deviations in instrumental alignment and calibration, and microprobe system software must conveniently verify the necessary parameters. Microanalysis of mission critical materials requires an ongoing demonstration of instrumental calibration. Possible approaches to improvements in instrument calibration, quality control, and accuracy will be discussed. Development of a set of core requirements based on discussions with users, researchers, and manufacturers can yield documents that improve and unify the methods by which instruments can be calibrated. These results can be used to

Security Quality Requirements Engineering (SQUARE): Case Study Phase III

DTIC Science & Technology

2006-05-01

Security Quality Requirements Engineering (SQUARE): Case Study Phase III Lydia Chung Frank Hung Eric Hough Don Ojoko-Adams Advisor...Engineering (SQUARE): Case Study Phase III CMU/SEI-2006-SR-003 Lydia Chung Frank Hung Eric Hough Don Ojoko-Adams Advisor Nancy R. Mead...1 1.1 The SQUARE Process ............................................................................... 1 1.2 Case Study Clients

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.

Louisiana Quality Start Child Care Rating System: QRS Profile. The Child Care Quality Rating System (QRS) Assessment

ERIC Educational Resources Information Center

Child Trends, 2010

2010-01-01

This paper presents a profile of Louisiana's Quality Start Child Care Rating System prepared as part of the Child Care Quality Rating System (QRS) Assessment Study. The profile consists of several sections and their corresponding descriptions including: (1) Program Information; (2) Rating Details; (3) Quality Indicators for Center-Based Programs;…

Quality Rating and Improvement Systems: A Strategic Movement for Defining Quality

ERIC Educational Resources Information Center

Neugebauer, Roger

2009-01-01

One of the most important trends in the early childhood field is the emergence of quality rating systems (QRS), or quality rating and improvement systems (QRIS), which are designed to assess, improve, and communicate the level of quality of early and school-age care programs. QRS came onto the scene in 1998 when Oklahoma enacted its "Reaching…

Soft wheat quality characteristics required for making baking powder biscuits

USDA-ARS?s Scientific Manuscript database

Fifteen soft wheat varieties were evaluated for their grain, milling, flour and dough mixing characteristics, as well as their solvent retention capacities (SRCs), pasting properties and suitability for making baking powder biscuits, to identify wheat quality characteristics required for making bisc...

[Definition and specification requirements for PAC-systems (picture archiving and communication system). A performance index with reference to the standard "IEEE Recommended Practice for Software Requirement Specifications"].

PubMed

König, H; Klose, K J

1999-04-01

The formulation of requirements is necessary to control the goals of a PACS project. Furthermore, in this way, the scope of functionality necessary to support radiological working processes becomes clear. Definitions of requirements and specification are formulated independently of systems according to the IEEE standard "Recommended Practice for Software Requirements Specifications". Definitions are given in the Request for Information, specifications in the Request for Proposal. Functional and non-functional requirements are distinguished. The solutions are rated with respect to scope, appropriateness and quality of implementation. A PACS checklist was created according to the methods described above. It is published on the homepage of the "Arbeitsgemeinschaft Informationstechnologie" (AGIT) within the "Deutsche Röntgengesellschaft" (DRG) (http://www.uni-marburg.de/mzr/agit). The checklist provides a discussion forum which should contribute to an agreement on accepted basic PACS functionalities.

14 CFR 145.211 - Quality control system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Quality control system. 145.211 Section 145...) SCHOOLS AND OTHER CERTIFICATED AGENCIES REPAIR STATIONS Operating Rules § 145.211 Quality control system. (a) A certificated repair station must establish and maintain a quality control system acceptable to...

14 CFR 145.211 - Quality control system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Quality control system. 145.211 Section 145...) SCHOOLS AND OTHER CERTIFICATED AGENCIES REPAIR STATIONS Operating Rules § 145.211 Quality control system. (a) A certificated repair station must establish and maintain a quality control system acceptable to...

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.

Quality evaluation of health information system's architectures developed using the HIS-DF methodology.

PubMed

López, Diego M; Blobel, Bernd; Gonzalez, Carolina

2010-01-01

Requirement analysis, design, implementation, evaluation, use, and maintenance of semantically interoperable Health Information Systems (HIS) have to be based on eHealth standards. HIS-DF is a comprehensive approach for HIS architectural development based on standard information models and vocabulary. The empirical validity of HIS-DF has not been demonstrated so far. Through an empirical experiment, the paper demonstrates that using HIS-DF and HL7 information models, semantic quality of HIS architecture can be improved, compared to architectures developed using traditional RUP process. Semantic quality of the architecture has been measured in terms of model's completeness and validity metrics. The experimental results demonstrated an increased completeness of 14.38% and an increased validity of 16.63% when using the HIS-DF and HL7 information models in a sample HIS development project. Quality assurance of the system architecture in earlier stages of HIS development presumes an increased quality of final HIS systems, which supposes an indirect impact on patient care.

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Sampling requirements for forage quality characterization of rectangular hay bales

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

Sheaffer, C.C.; Martin, N.P.; Jewett, J.G.

2000-02-01

Commercial lots of alfalfa (Medicago sativa L.) hay are often bought and sold on the basis of forage quality. Proper sampling is essential to obtain accurate forage quality results for pricing of alfalfa hay, but information about sampling is limited to small, 20- to 40-kg rectangular bales. Their objectives were to determine the within-bale variation in 400-kg rectangular bales and to determine the number and distribution of core samples required to represent the crude protein (CP), acid detergent fiber (ADF), neutral detergent fiber (NDF), and dry matter (DM) concentration in commercial lots of alfalfa hay. Four bales were selected frommore » each of three hay lots and core sampled nine times per side for a total of 54 cores per bale. There was no consistent pattern of forage quality variation within bales. Averaged across lots, any portion of a bale was highly correlated with bale grand means for CP, ADF, NDF, and DM. Three lots of hay were probed six times per bale, one core per bale side from 55, 14, and 14 bales per lot. For determination of CP, ADF, NDF, and DM concentration, total core numbers required to achieve an acceptable standard error (SE) were minimized by sampling once per bale. Bootstrap analysis of data from the most variable hay lot suggested that forage quality of any lot of 400-kg alfalfa hay bales should be adequately represented by 12 bales sampled once per bale.« less

LEGO plot for simultaneous application of multiple quality requirements during trueness verification of quantitative laboratory tests.

PubMed

Park, Hae-il; Chae, Hyojin; Kim, Myungshin; Lee, Jehoon; Kim, Yonggoo

2014-03-01

We developed a two-dimensional plot for viewing trueness that takes into account potential shift and variable quality requirements to verify trueness using certified reference material (CRM). Glucose, total cholesterol (TC), and creatinine levels were determined by two kinds of assay in two levels of a CRM. Available quality requirements were collected, codified, and sorted in an ascending order in the plot's header row. Centering on the mean of measured values from CRM, the "mean ± US CLIA '88 allowable total error" was located in the header of the leftmost and rightmost columns. Twenty points were created in intervening columns as potential shifts. Uncertainties were calculated according to regression between certified values and uncertainties of CRM, and positioned in the corresponding columns. Cells were assigned different colors where column and row intersected based on comparison of the 95% confidence interval of the percentage bias with each quality requirement. A glucose assay failed to meet the highest quality criteria, for which shift of +0.13-0.14 mmol/l was required. A TC assay met the quality requirement and a shift of ±0.03 mmol/l was tolerable. A creatinine assay also met the quality requirement but any shift was not tolerable. The plot provides a systematic view of the trueness of quantitative laboratory tests. © 2014 Wiley Periodicals, Inc.

Water quality modeling using geographic information system (GIS) data

NASA Technical Reports Server (NTRS)

Engel, Bernard A

1992-01-01

Protection of the environment and natural resources at the Kennedy Space Center (KSC) is of great concern. The potential for surface and ground water quality problems resulting from non-point sources of pollution was examined using models. Since spatial variation of parameters required was important, geographic information systems (GIS) and their data were used. The potential for groundwater contamination was examined using the SEEPAGE (System for Early Evaluation of the Pollution Potential of Agricultural Groundwater Environments) model. A watershed near the VAB was selected to examine potential for surface water pollution and erosion using the AGNPS (Agricultural Non-Point Source Pollution) model.

Intelligent redundant actuation system requirements and preliminary system design

NASA Technical Reports Server (NTRS)

Defeo, P.; Geiger, L. J.; Harris, J.

1985-01-01

Several redundant actuation system configurations were designed and demonstrated to satisfy the stringent operational requirements of advanced flight control systems. However, this has been accomplished largely through brute force hardware redundancy, resulting in significantly increased computational requirements on the flight control computers which perform the failure analysis and reconfiguration management. Modern technology now provides powerful, low-cost microprocessors which are effective in performing failure isolation and configuration management at the local actuator level. One such concept, called an Intelligent Redundant Actuation System (IRAS), significantly reduces the flight control computer requirements and performs the local tasks more comprehensively than previously feasible. The requirements and preliminary design of an experimental laboratory system capable of demonstrating the concept and sufficiently flexible to explore a variety of configurations are discussed.

Quality and Safety Implications of Emergency Department Information Systems

PubMed Central

Farley, Heather L.; Baumlin, Kevin M.; Hamedani, Azita G.; Cheung, Dickson S.; Edwards, Michael R.; Fuller, Drew C.; Genes, Nicholas; Griffey, Richard T.; Kelly, John J.; McClay, James C.; Nielson, Jeff; Phelan, Michael P.; Shapiro, Jason S.; Stone-Griffith, Suzanne; Pines, Jesse M.

2013-01-01

The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services “meaningful use” incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals’ electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital’s or physician group’s approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system’s ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or

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 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

PubMed

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

Total Quality Management of Information System for Quality Assessment of Pesantren Using Fuzzy-SERVQUAL

NASA Astrophysics Data System (ADS)

Faizah, Arbiati; Syafei, Wahyul Amien; Isnanto, R. Rizal

2018-02-01

This research proposed a model combining an approach of Total Quality Management (TQM) and Fuzzy method of Service Quality (SERVQUAL) to asses service quality. TQM implementation was as quality management orienting on customer's satisfaction by involving all stakeholders. SERVQUAL model was used to measure quality service based on five dimensions such as tangible, reliability, responsiveness, assurance, and empathy. Fuzzy set theory was to accommodate subjectivity and ambiguity of quality assessment. Input data consisted of indicator data and quality assessment aspect. Input data was, then, processed to be service quality assessment questionnaires of Pesantren by using Fuzzy method to get service quality score. This process consisted of some steps as follows : inputting dimension and questionnaire data to data base system, filling questionnaire through system, then, system calculated fuzzification, defuzzification, gap of quality expected and received by service receivers, and calculating each dimension rating showing quality refinement priority. Rating of each quality dimension was, then, displayed at dashboard system to enable users to see information. From system having been built, it could be known that tangible dimension had the highest gap, -0.399, thus it needs to be prioritized and gets evaluation and refinement action soon.

Assessing decision quality in patient-centred care requires a preference-sensitive measure

PubMed Central

Kaltoft, Mette; Cunich, Michelle; Salkeld, Glenn; Dowie, Jack

2014-01-01

A theory-based instrument for measuring the quality of decisions made using any form of decision technology, including both decision-aided and unaided clinical consultations is required to enable person- and patient-centred care and to respond positively to individual heterogeneity in the value aspects of decision making. Current instruments using the term ‘decision quality’ have adopted a decision- and thus condition-specific approach. We argue that patient-centred care requires decision quality to be regarded as both preference-sensitive across multiple relevant criteria and generic across all conditions and decisions. MyDecisionQuality is grounded in prescriptive multi criteria decision analysis and employs a simple expected value algorithm to calculate a score for the quality of a decision that combines, in the clinical case, the patient’s individual preferences for eight quality criteria (expressed as importance weights) and their ratings of the decision just taken on each of these criteria (expressed as performance rates). It thus provides an index of decision quality that encompasses both these aspects. It also provides patients with help in prioritizing quality criteria for future decision making by calculating, for each criterion, the Incremental Value of Perfect Rating, that is, the increase in their decision quality score that would result if their performance rating on the criterion had been 100%, weightings unchanged. MyDecisionQuality, which is a web-based generic and preference-sensitive instrument, can constitute a key patient-reported measure of the quality of the decision-making process. It can provide the basis for future decision improvement, especially when the clinician (or other stakeholders) completes the equivalent instrument and the extent and nature of concordance and discordance can be established. Apart from its role in decision preparation and evaluation, it can also provide real time and relevant documentation for the patient�

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

Requirements Analysis for Information-Intensive Systems

NASA Technical Reports Server (NTRS)

Callender, E. D.; Hartsough, C.; Morris, R. V.; Yamamoto, Y.

1986-01-01

Report discusses role of requirements analysis in development of information-intensive systems. System examined from variety of human viewpoints during design, development, and implementation. Such examination, called requirements analysis, ensures system simultaneously meets number of distinct but interacting needs. Viewpoints defined and integrated to help attain objectives.

Design requirements for SRB production control system. Volume 2: System requirements and conceptual description

NASA Technical Reports Server (NTRS)

1981-01-01

In the development of the business system for the SRB automated production control system, special attention had to be paid to the unique environment posed by the space shuttle. The issues posed by this environment, and the means by which they were addressed, are reviewed. The change in management philosphy which will be required as NASA switches from one-of-a-kind launches to multiple launches is discussed. The implications of the assembly process on the business system are described. These issues include multiple missions, multiple locations and facilities, maintenance and refurbishment, multiple sources, and multiple contractors. The implications of these aspects on the automated production control system are reviewed including an assessment of the six major subsystems, as well as four other subsystem. Some general system requirements which flow through the entire business system are described.

Design requirements for SRB production control system. Volume 3: Package evaluation, modification and hardware

NASA Technical Reports Server (NTRS)

1981-01-01

The software package evaluation was designed to analyze commercially available, field-proven, production control or manufacturing resource planning management technology and software package. The analysis was conducted by comparing SRB production control software requirements and conceptual system design to software package capabilities. The methodology of evaluation and the findings at each stage of evaluation are described. Topics covered include: vendor listing; request for information (RFI) document; RFI response rate and quality; RFI evaluation process; and capabilities versus requirements.

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...

Portable water quality monitoring system

NASA Astrophysics Data System (ADS)

Nizar, N. B.; Ong, N. R.; Aziz, M. H. A.; Alcain, J. B.; Haimi, W. M. W. N.; Sauli, Z.

2017-09-01

Portable water quality monitoring system was a developed system that tested varied samples of water by using different sensors and provided the specific readings to the user via short message service (SMS) based on the conditions of the water itself. In this water quality monitoring system, the processing part was based on a microcontroller instead of Lead and Copper Rule (LCR) machines to receive the results. By using four main sensors, this system obtained the readings based on the detection of the sensors, respectively. Therefore, users can receive the readings through SMS because there was a connection between Arduino Uno and GSM Module. This system was designed to be portable so that it would be convenient for users to carry it anywhere and everywhere they wanted to since the processor used is smaller in size compared to the LCR machines. It was also developed to ease the user to monitor and control the water quality. However, the ranges of the sensors' detection still a limitation in this study.

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Hydrologic and Water Quality System (HAWQS)

EPA Science Inventory

The Hydrologic and Water Quality System (HAWQS) is a web-based interactive water quantity and quality modeling system that employs as its core modeling engine the Soil and Water Assessment Tool (SWAT), an internationally-recognized public domain model. HAWQS provides users with i...

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...

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)

System Proposal for Mass Transit Service Quality Control Based on GPS Data

PubMed Central

Padrón, Gabino; Cristóbal, Teresa; Alayón, Francisco; Quesada-Arencibia, Alexis; García, Carmelo R.

2017-01-01

Quality is an essential aspect of public transport. In the case of regular public passenger transport by road, punctuality and regularity are criteria used to assess quality of service. Calculating metrics related to these criteria continuously over time and comprehensively across the entire transport network requires the handling of large amounts of data. This article describes a system for continuously and comprehensively monitoring punctuality and regularity. The system uses location data acquired continuously in the vehicles and automatically transferred for analysis. These data are processed intelligently by elements that are commonly used by transport operators: GPS-based tracking system, onboard computer and wireless networks for mobile data communications. The system was tested on a transport company, for which we measured the punctuality of one of the routes that it operates; the results are presented in this article. PMID:28621745

System Proposal for Mass Transit Service Quality Control Based on GPS Data.

PubMed

Padrón, Gabino; Cristóbal, Teresa; Alayón, Francisco; Quesada-Arencibia, Alexis; García, Carmelo R

2017-06-16

Quality is an essential aspect of public transport. In the case of regular public passenger transport by road, punctuality and regularity are criteria used to assess quality of service. Calculating metrics related to these criteria continuously over time and comprehensively across the entire transport network requires the handling of large amounts of data. This article describes a system for continuously and comprehensively monitoring punctuality and regularity. The system uses location data acquired continuously in the vehicles and automatically transferred for analysis. These data are processed intelligently by elements that are commonly used by transport operators: GPS-based tracking system, onboard computer and wireless networks for mobile data communications. The system was tested on a transport company, for which we measured the punctuality of one of the routes that it operates; the results are presented in this article.

Laboratory quality management system: road to accreditation and beyond.

PubMed

Wadhwa, V; Rai, S; Thukral, T; Chopra, M

2012-01-01

This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS) for a medical testing and diagnostic laboratory in a holistic way and hopes to expand the horizon beyond quality control (QC) and quality assurance. It provides an insight on accreditation bodies and highlights a glimpse of existing laboratory practices but essentially it takes the reader through the journey of accreditation and during the course of reading and understanding this document, prepares the laboratory for the same. Some of the areas which have not been highlighted previously include: requirement for accreditation consultants, laboratory infrastructure and scope, applying for accreditation, document preparation. This section is well supported with practical illustrations and necessary tables and exhaustive details like preparation of a standard operating procedure and a quality manual. Concept of training and privileging of staff has been clarified and a few of the QC exercises have been dealt with in a novel way. Finally, a practical advice for facing an actual third party assessment and caution needed to prevent post-assessment pitfalls has been dealt with.

7 CFR 1770.11 - Accounting system requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 12 2010-01-01 2010-01-01 false Accounting system requirements. 1770.11 Section 1770..., DEPARTMENT OF AGRICULTURE (CONTINUED) ACCOUNTING REQUIREMENTS FOR RUS TELECOMMUNICATIONS BORROWERS Uniform System of Accounts § 1770.11 Accounting system requirements. (a) Each RUS borrower subject to the...

7 CFR 1767.12 - Accounting system requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 12 2010-01-01 2010-01-01 false Accounting system requirements. 1767.12 Section 1767..., DEPARTMENT OF AGRICULTURE (CONTINUED) ACCOUNTING REQUIREMENTS FOR RUS ELECTRIC BORROWERS Uniform System of Accounts § 1767.12 Accounting system requirements. (a) Each Rural Development electric borrower must...

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.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Vehicle systems and payload requirements evaluation. [computer programs for identifying launch vehicle system requirements

NASA Technical Reports Server (NTRS)

Rea, F. G.; Pittenger, J. L.; Conlon, R. J.; Allen, J. D.

1975-01-01

Techniques developed for identifying launch vehicle system requirements for NASA automated space missions are discussed. Emphasis is placed on development of computer programs and investigation of astrionics for OSS missions and Scout. The Earth Orbit Mission Program - 1 which performs linear error analysis of launch vehicle dispersions for both vehicle and navigation system factors is described along with the Interactive Graphic Orbit Selection program which allows the user to select orbits which satisfy mission requirements and to evaluate the necessary injection accuracy.

A reliable sewage quality abnormal event monitoring system.

PubMed

Li, Tianling; Winnel, Melissa; Lin, Hao; Panther, Jared; Liu, Chang; O'Halloran, Roger; Wang, Kewen; An, Taicheng; Wong, Po Keung; Zhang, Shanqing; Zhao, Huijun

2017-09-15

With closing water loop through purified recycled water, wastewater becomes a part of source water, requiring reliable wastewater quality monitoring system (WQMS) to manage wastewater source and mitigate potential health risks. However, the development of reliable WQMS is fatally constrained by severe contamination and biofouling of sensors due to the hostile analytical environment of wastewaters, especially raw sewages, that challenges the limit of existing sensing technologies. In this work, we report a technological solution to enable the development of WQMS for real-time abnormal event detection with high reliability and practicality. A vectored high flow hydrodynamic self-cleaning approach and a dual-sensor self-diagnostic concept are adopted for WQMS to effectively encounter vital sensor failing issues caused by contamination and biofouling and ensure the integrity of sensing data. The performance of the WQMS has been evaluated over a 3-year trial period at different sewage catchment sites across three Australian states. It has demonstrated that the developed WQMS is capable of continuously operating in raw sewage for a prolonged period up to 24 months without maintenance and failure, signifying the high reliability and practicality. The demonstrated WQMS capability to reliably acquire real-time wastewater quality information leaps forward the development of effective wastewater source management system. The reported self-cleaning and self-diagnostic concepts should be applicable to other online water quality monitoring systems, opening a new way to encounter the common reliability and stability issues caused by sensor contamination and biofouling. Copyright © 2017 Elsevier Ltd. All rights reserved.

Strategies for monitoring the bacteriological quality of water supply in distribution systems

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

Geldreich, E.E.; Goodrich, J.A.; Clark, R.M.

1989-01-01

Monitoring strategies for characterizing the bacteriological quality of water in the distribution system require a complete understanding of a variety of interrelated aspects that include treated water quality, water-supply retention in storage and infrastructure deterioration in the distribution system. A study of field data from several water-supply utilities was used to highlight some innovative interpretations of compliance monitoring data. Major perceptions include: The use of a 5% coliform frequency of occurrence limit highlights compliance significance in those situations where there are clusters of positive samples containing less than 4 coliforms per 100 mL. Unfortunately, this presence/absence concept does not providemore » any indication of the magnitude of a contamination event.« less

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.

78 FR 72620 - Federal Acquisition Regulation; Higher-Level Contract Quality Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-03

... DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE.... IV. Regulatory Flexibility Act The Department of Defense (DoD), the General Services Administration...-AM65 Federal Acquisition Regulation; Higher-Level Contract Quality Requirements AGENCY: Department of...

42 CFR 441.585 - Quality assurance system.

Code of Federal Regulations, 2012 CFR

2012-10-01

... provides information about the provisions of quality improvement and assurance to each individual receiving... 42 Public Health 4 2012-10-01 2012-10-01 false Quality assurance system. 441.585 Section 441.585...) § 441.585 Quality assurance system. (a) States must establish and maintain a comprehensive, continuous...

Air Quality System (AQS) Metadata

EPA Pesticide Factsheets

The U.S. Environmental Protection Agency compiles air quality monitoring data in the Air Quality System (AQS). Ambient air concentrations are measured at a national network of more than 4,000 monitoring stations and are reported by state, local, and tribal

Requirements based system risk modeling

NASA Technical Reports Server (NTRS)

Meshkat, Leila; Cornford, Steven; Feather, Martin

2004-01-01

The problem that we address in this paper is assessing the expected degree of success of the system or mission based on the degree to which each requirement is satisfied and the relative weight of the requirements. We assume a complete list of the requirements, the relevant risk elements and their probability of occurrence and the quantified effect of the risk elements on the requirements. In order to assess the degree to which each requirement is satisfied, we need to determine the effect of the various risk elements on the requirement.

Effect of a commercial housing system on egg quality during extended storage.

PubMed

Jones, D R; Karcher, D M; Abdo, Z

2014-05-01

Egg producers in the United States are utilizing a variety of commercial egg production systems to provide consumer choice and meet legislative requirements. Consumer egg grades in the United States were developed for conventional cage production, and it is unclear what effect alternative production systems might have on egg quality during retail and consumer home storage. The current study was undertaken to determine what changes in egg quality characteristics occur during extended cold storage for commercially produced conventional cage, enriched colony cage, and cage-free aviary eggs. During 12 wk of cold storage, egg weight, albumen height, Haugh unit, static compression shell strength, vitelline membrane strength and deformation, yolk index, shell dynamic stiffness, and whole egg total solids were monitored. Overall, aviary and enriched eggs were significantly (P < 0.05) heavier than conventional cage. Albumen height and Haugh unit (P < 0.05) were significantly greater for conventional cage than enriched eggs. Static compression shell strength was greatest (P < 0.05) for enriched eggs compared with aviary. No overall housing system effects for yolk measurements, shell dynamic stiffness, or whole egg total solids were observed. Albumen height, Haugh unit, and yolk quality measurements were all greatest at 0 and lowest at 12 wk of storage (P < 0.05). The rate of quality change among the housing systems for each measured attribute at 4, 6, and 12 wk was determined. Other than differences in the change of egg weight at 4 wk, no significant differences in the rate of quality decline were found among the housing systems. The results of the current study indicate that current US egg quality standards should effectively define quality for commercially produced conventional cage, enriched colony cage, and cage-free aviary eggs.

Detailed design of a Ride Quality Augmentation System for commuter aircraft

NASA Technical Reports Server (NTRS)

Suikat, Reiner; Donaldson, Kent E.; Downing, David R.

1989-01-01

The design of a Ride Quality Augmentation System (RQAS) for commuter aircraft is documented. The RQAS is designed for a Cessna 402B, an 8 passenger prop twin representative to this class of aircraft. The purpose of the RQAS is the reduction of vertical and lateral accelerations of the aircraft due to atmospheric turbulence by the application of active control. The detailed design of the hardware (the aircraft modifications, the Ride Quality Instrumentation System (RQIS), and the required computer software) is examined. The aircraft modifications, consisting of the dedicated control surfaces and the hydraulic actuation system, were designed at Cessna Aircraft by Kansas University-Flight Research Laboratory. The instrumentation system, which consist of the sensor package, the flight computer, a Data Acquisition System, and the pilot and test engineer control panels, was designed by NASA-Langley. The overall system design and the design of the software, both for flight control algorithms and ground system checkout are detailed. The system performance is predicted from linear simulation results and from power spectral densities of the aircraft response to a Dryden gust. The results indicate that both accelerations are possible.

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).

How to Compare the Security Quality Requirements Engineering (SQUARE) Method with Other Methods

DTIC Science & Technology

2007-08-01

Attack Trees for Modeling and Analysis 10 2.8 Misuse and Abuse Cases 10 2.9 Formal Methods 11 2.9.1 Software Cost Reduction 12 2.9.2 Common...modern or efficient techniques. • Requirements analysis typically is either not performed at all (identified requirements are directly specified without...any analysis or modeling) or analysis is restricted to functional re- quirements and ignores quality requirements, other nonfunctional requirements

Colometer: a real-time quality feedback system for screening colonoscopy.

PubMed

Filip, Dobromir; Gao, Xuexin; Angulo-Rodríguez, Leticia; Mintchev, Martin P; Devlin, Shane M; Rostom, Alaa; Rosen, Wayne; Andrews, Christopher N

2012-08-28

rating from the automated system and the reviewers was 3.45 [interquartile range (IQR), 3.1-3.68] and 3.00 (IQR, 2.33-3.67) respectively for all colonoscopy video samples. The automated rating revealed a strong correlation with the reviewer's rating (ρ coefficient= 0.65, P = 0.01). There was good correlation of the automated overall quality rating and the mean endoscopist withdrawal speed rating (Spearman r coefficient= 0.59, P = 0.03). There was no correlation of automated overall quality rating with mean endoscopists image quality rating (Spearman r coefficient= 0.41, P = 0.15). The results from a novel automated real-time colonoscopy quality feedback system strongly agreed with the endoscopists' quality assessments. Further study is required to validate this approach.

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...

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

, 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.

"Power quality system," a new system of quality management for globalization: towards innovation and competitive advantages.

PubMed

Abdul-Rahman, H; Berawi, M A

Knowledge Management (KM) addresses the critical issues of organizational adoption, survival and competence in the face of an increasingly changing environment. KM embodies organizational processes that seek a synergistic combination of the data and information processing capabilities of information and communication technologies (ICT), and the creative and innovative capacity of human beings to improve ICT In that role, knowledge management will improve quality management and avoid or minimize losses and weakness that usually come from poor performance as well as increase the competitive level of the company and its ability to survive in the global marketplace. To achieve quality, all parties including the clients, company consultants, contractors, entrepreneurs, suppliers, and the governing bodies (i.e., all involved stake-holders) need to collaborate and commit to achieving quality. The design based organizations in major business and construction companies have to be quality driven to support healthy growth in today's competitive market. In the march towards vision 2020 and globalization (i.e., the one world community) of many companies, their design based organizations need to have superior quality management and knowledge management to anticipate changes. The implementation of a quality system such as the ISO 9000 Standards, Total Quality Management, or Quality Function Deployment (QFD) focuses the company's resources towards achieving faster and better results in the global market with less cost. To anticipate the needs of the marketplace and clients as the world and technology change, a new system, which we call Power Quality System (PQS), has been designed. PQS is a combination of information and communication technologies (ICT) and the creative and innovative capacity of human beings to meet the challenges of the new world business and to develop high quality products.

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

Technology usage, quality management system, and service quality in Thailand.

PubMed

Sivabrovornvatana, Nilubon; Siengthai, Sununta; Krairit, Donyaprueth; Paul, Himangshu

2005-01-01

This article aims to explore the relationship between technology and quality management for enhancing Thai hospital service quality. The paper presents the findings of an exploratory study that investigates service quality from the customer and service provider perception. In-depth interviews were conducted with respondents in Thai hospitals. The interviews explored service-related factors that patients and service providers perceive to be important for hospital services. The first interview group consisted of professionals as internal customers in direct contact with external customers, while the second group consisted of external customers of the same hospitals. The study's outcomes clearly suggest factors that make significant contribution to service quality. These factors can be categorized according to five SERVQUAL dimensions (reliability, responsiveness, assurance, empathy, and tangibility), although some factors required slightly different interpretation. The findings suggest that hospitals can develop an appropriate approach to their advantage, which can yield sustainable improvement in service quality as perceived by patients and professionals. Hospitals can make better quality decisions based on structured measurement and knowledge. It is recommended that managers apply this knowledge for successful implementation of activities related to service quality in their organizations.

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.

In pursuit of quality by viable quality assurance system: the controllers' perceptions.

PubMed

Aziz, Anwar

2011-01-01

Patients, families and communities expect safe, competent and compassionate nursing care that has always been a core value of nursing. To meet these expectations, a valid and reliable quality assurance (QA) system is crucial to ensure that nurse-graduates are competent, confident and fit to practice. The QA approach is seen to be fundamental for quality improvement, it would be appropriate to consider its influence in the nursing education in Pakistan as the current situation is evident of non-existence of such a system to assure its quality. The data is drawn from a qualitative case study conducted in 2004. Among a purposive sample of 71 nurses inclusive of a group of Controllers were interviewed on one-to-one basis. Interviews were audio taped to reduce the risk of any misinterpretation and to facilitate the exact description of data as it was said. The non-directive, semi-structured and open-ended questionnaire was used to collect data. Thematic analysis of verbatim transcripts of the interviews was done. The study findings reveal a unanimous desire of the nurses to gauge quality of nurse education through efficient and effective quality assurance system. A crucial need is felt to develop a viable quality assurance system to ensure approved level of quality in nursing education to deliver the right care to the right patient at the right time, every time. The continuous quality assurance and improvement (CQAI) framework based on Deming Quality Cycle (Plan, Do, Check and Act) could facilitate appropriate designing and development of mechanism.

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.

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.

Quality monitored distributed voting system

DOEpatents

Skogmo, David

1997-01-01

A quality monitoring system can detect certain system faults and fraud attempts in a distributed voting system. The system uses decoy voters to cast predetermined check ballots. Absent check ballots can indicate system faults. Altered check ballots can indicate attempts at counterfeiting votes. The system can also cast check ballots at predetermined times to provide another check on the distributed voting system.

An airborne remote sensing system for urban air quality

NASA Technical Reports Server (NTRS)

Duncan, L. J.; Friedman, E. J.; Keitz, E. L.; Ward, E. A.

1974-01-01

Several NASA sponsored remote sensors and possible airborne platforms were evaluated. Outputs of dispersion models for SO2 and CO pollution in the Washington, D.C. area were used with ground station data to establish the expected performance and limitations of the remote sensors. Aircraft/sensor support requirements are discussed. A method of optimum flight plan determination was made. Cost trade offs were performed. Conclusions about the implementation of various instrument packages as parts of a comprehensive air quality monitoring system in Washington are presented.

Advanced EVA system design requirements study

NASA Technical Reports Server (NTRS)

Woods, T. G.

1988-01-01

The results are presented of a study to identify specific criteria regarding space station extravehicular activity system (EVAS) hardware requirements. Key EVA design issues include maintainability, technology readiness, LSS volume vs. EVA time available, suit pressure/cabin pressure relationship and productivity effects, crew autonomy, integration of EVA as a program resource, and standardization of task interfaces. A variety of DOD EVA systems issues were taken into consideration. Recommendations include: (1) crew limitations, not hardware limitations; (2) capability to perform all of 15 generic missions; (3) 90 days on-orbit maintainability with 50 percent duty cycle as minimum; and (4) use by payload sponsors of JSC document 10615A plus a Generic Tool Kit and Specialized Tool Kit description. EVA baseline design requirements and criteria, including requirements of various subsystems, are outlined. Space station/EVA system interface requirements and EVA accommodations are discussed in the areas of atmosphere composition and pressure, communications, data management, logistics, safe haven, SS exterior and interior requirements, and SS airlock.

Quality Systems and ISO 9000 in Higher Education.

ERIC Educational Resources Information Center

Lundquist, Robert

1997-01-01

Examines quality assurance systems in higher education in general and of ISO 9000, a set of international quality standards, in particular. Reports on a survey of 23 institutions worldwide concerning implementation of quality systems and application of the ISO 9000 standards. Concludes that while institutions have found the quality assurance…

[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.

40 CFR 91.327 - Sampling system requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Sampling system requirements. 91.327....327 Sampling system requirements. (a) Sample component surface temperature. For sampling systems which..., sample line section, filters, and so forth) in the heated portion of the sampling system that has a...

40 CFR 91.327 - Sampling system requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Sampling system requirements. 91.327....327 Sampling system requirements. (a) Sample component surface temperature. For sampling systems which..., sample line section, filters, and so forth) in the heated portion of the sampling system that has a...

49 CFR 228.313 - Electrical system requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Electrical system requirements. 228.313 Section...; SLEEPING QUARTERS Safety and Health Requirements for Camp Cars Provided by Railroads as Sleeping Quarters § 228.313 Electrical system requirements. (a) All heating, cooking, ventilation, air conditioning, and...

49 CFR 228.313 - Electrical system requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Electrical system requirements. 228.313 Section...; SLEEPING QUARTERS Safety and Health Requirements for Camp Cars Provided by Railroads as Sleeping Quarters § 228.313 Electrical system requirements. (a) All heating, cooking, ventilation, air conditioning, and...

49 CFR 228.313 - Electrical system requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Electrical system requirements. 228.313 Section...; SLEEPING QUARTERS Safety and Health Requirements for Camp Cars Provided by Railroads as Sleeping Quarters § 228.313 Electrical system requirements. (a) All heating, cooking, ventilation, air conditioning, and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

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

Quality monitored distributed voting system

DOEpatents

Skogmo, D.

1997-03-18

A quality monitoring system can detect certain system faults and fraud attempts in a distributed voting system. The system uses decoy voters to cast predetermined check ballots. Absent check ballots can indicate system faults. Altered check ballots can indicate attempts at counterfeiting votes. The system can also cast check ballots at predetermined times to provide another check on the distributed voting system. 6 figs.

Quality Assurance and T&E of Inertial Systems for RLV Mission

NASA Astrophysics Data System (ADS)

Sathiamurthi, S.; Thakur, Nayana; Hari, K.; Peter, Pilmy; Biju, V. S.; Mani, K. S.

2017-12-01

This work describes the quality assurance and Test and Evaluation (T&E) activities carried out for the inertial systems flown successfully in India's first reusable launch vehicle technology demonstrator hypersonic experiment mission. As part of reliability analysis, failure mode effect and criticality analysis and derating analysis were carried out in the initial design phase, findings presented to design review forums and the recommendations were implemented. T&E plan was meticulously worked out and presented to respective forums for review and implementation. Test data analysis, health parameter plotting and test report generation was automated and these automations significantly reduced the time required for these activities and helped to avoid manual errors. Further, T&E cycle is optimized without compromising on quality aspects. These specific measures helped to achieve zero defect delivery of inertial systems for RLV application.

FPGA-based firmware model for extended measurement systems with data quality monitoring

NASA Astrophysics Data System (ADS)

Wojenski, A.; Pozniak, K. T.; Mazon, D.; Chernyshova, M.

2017-08-01

Modern physics experiments requires construction of advanced, modular measurement systems for data processing and registration purposes. Components are often designed in one of the common mechanical and electrical standards, e.g. VME or uTCA. The paper is focused on measurement systems using FPGAs as data processing blocks, especially for plasma diagnostics using GEM detectors with data quality monitoring aspects. In the article is proposed standardized model of HDL FPGA firmware implementation, for use in a wide range of different measurement system. The effort was made in term of flexible implementation of data quality monitoring along with source data dynamic selection. In the paper is discussed standard measurement system model followed by detailed model of FPGA firmware for modular measurement systems. Considered are both: functional blocks and data buses. In the summary, necessary blocks and signal lines are described. Implementation of firmware following the presented rules should provide modular design, with ease of change different parts of it. The key benefit is construction of universal, modular HDL design, that can be applied in different measurement system with simple adjustments.

The Requirements Generation System: A tool for managing mission requirements

NASA Technical Reports Server (NTRS)

Sheppard, Sylvia B.

1994-01-01

Historically, NASA's cost for developing mission requirements has been a significant part of a mission's budget. Large amounts of time have been allocated in mission schedules for the development and review of requirements by the many groups who are associated with a mission. Additionally, tracing requirements from a current document to a parent document has been time-consuming and costly. The Requirements Generation System (RGS) is a computer-supported cooperative-work tool that assists mission developers in the online creation, review, editing, tracing, and approval of mission requirements as well as in the production of requirements documents. This paper describes the RGS and discusses some lessons learned during its development.

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...

Air Quality System (AQS)

EPA Pesticide Factsheets

The Air Quality System (AQS) database contains measurements of air pollutant concentrations from throughout the United States and its territories. The measurements include both criteria air pollutants and hazardous air pollutants.

Civilian Radioactive Waste Management System Requirements Document

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

C.A. Kouts

2006-05-10

The CRD addresses the requirements of Department of Energy (DOE) Order 413.3-Change 1, ''Program and Project Management for the Acquisition of Capital Assets'', by providing the Secretarial Acquisition Executive (Level 0) scope baseline and the Program-level (Level 1) technical baseline. The Secretarial Acquisition Executive approves the Office of Civilian Radioactive Waste Management's (OCRWM) critical decisions and changes against the Level 0 baseline; and in turn, the OCRWM Director approves all changes against the Level 1 baseline. This baseline establishes the top-level technical scope of the CRMWS and its three system elements, as described in section 1.3.2. The organizations responsible formore » design, development, and operation of system elements described in this document must therefore prepare subordinate project-level documents that are consistent with the CRD. Changes to requirements will be managed in accordance with established change and configuration control procedures. The CRD establishes requirements for the design, development, and operation of the CRWMS. It specifically addresses the top-level governing laws and regulations (e.g., ''Nuclear Waste Policy Act'' (NWPA), 10 Code of Federal Regulations (CFR) Part 63, 10 CFR Part 71, etc.) along with specific policy, performance requirements, interface requirements, and system architecture. The CRD shall be used as a vehicle to incorporate specific changes in technical scope or performance requirements that may have significant program implications. Such may include changes to the program mission, changes to operational capability, and high visibility stakeholder issues. The CRD uses a systems approach to: (1) identify key functions that the CRWMS must perform, (2) allocate top-level requirements derived from statutory, regulatory, and programmatic sources, and (3) define the basic elements of the system architecture and operational concept. Project-level documents address CRD requirements by

Experiences and recommendations in deploying a real-time, water quality monitoring system

NASA Astrophysics Data System (ADS)

O'Flynn, B.; Regan, F.; Lawlor, A.; Wallace, J.; Torres, J.; O'Mathuna, C.

2010-12-01

Monitoring of water quality at a river basin level to meet the requirements of the Water Framework Directive (WFD) using conventional sampling and laboratory-based techniques poses a significant financial burden. Wireless sensing systems offer the potential to reduce these costs considerably, as well as provide more useful, continuous monitoring capabilities by giving an accurate idea of the changing environmental and water quality in real time. It is unlikely that the traditional spot/grab sampling will provide a reasonable estimate of the true maximum and/or mean concentration for a particular physicochemical variable in a water body with marked temporal variability. When persistent fluctuations occur, it is likely only to be detected through continuous measurements, which have the capability of detecting sporadic peaks of concentration. Thus, in situ sensors capable of continuous sampling of parameters required under the WFD would therefore provide more up-to-date information, cut monitoring costs and provide better coverage representing long-term trends in fluctuations of pollutant concentrations. DEPLOY is a technology demonstration project, which began planning and station selection and design in August 2008 aiming to show how state-of-the-art technology could be implemented for cost-effective, continuous and real-time monitoring of a river catchment. The DEPLOY project is seen as an important building block in the realization of a wide area autonomous network of sensors capable of monitoring the spatial and temporal distribution of important water quality and environmental target parameters. The demonstration sites chosen are based in the River Lee, which flows through Ireland's second largest city, Cork, and were designed to include monitoring stations in five zones considered typical of significant river systems--these monitor water quality parameters such as pH, temperature, depth, conductivity, turbidity and dissolved oxygen. Over one million data points

Organizing Performance Requirements For Dynamical Systems

NASA Technical Reports Server (NTRS)

Malchow, Harvey L.; Croopnick, Steven R.

1990-01-01

Paper describes methodology for establishing performance requirements for complicated dynamical systems. Uses top-down approach. In series of steps, makes connections between high-level mission requirements and lower-level functional performance requirements. Provides systematic delineation of elements accommodating design compromises.

42 CFR 493.1299 - Standard: Postanalytic systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Postanalytic systems quality assessment... Nonwaived Testing Postanalytic Systems § 493.1299 Standard: Postanalytic systems quality assessment. (a) The....1291. (b) The postanalytic systems quality assessment must include a review of the effectiveness of...

HAWQS (Hydrologic and Water Quality System)

EPA Pesticide Factsheets

A water quantity and quality modeling system to evaluate the impacts of management alternatives, pollution control scenarios, and climate change scenarios on the quantity and quality of water at a national scale.

Electrocardiogram Scanner-System Requirements

DOT National Transportation Integrated Search

1973-03-01

An experimental and analytical study has been conducted to establish the feasibility for scanning and digitizing electrocardiogram records. The technical requirements and relative costs for two systems are discussed herein. One is designed to automat...

Systems and context modeling approach to requirements analysis

NASA Astrophysics Data System (ADS)

Ahuja, Amrit; Muralikrishna, G.; Patwari, Puneet; Subhrojyoti, C.; Swaminathan, N.; Vin, Harrick

2014-08-01

Ensuring completeness and correctness of the requirements for a complex system such as the SKA is challenging. Current system engineering practice includes developing a stakeholder needs definition, a concept of operations, and defining system requirements in terms of use cases and requirements statements. We present a method that enhances this current practice into a collection of system models with mutual consistency relationships. These include stakeholder goals, needs definition and system-of-interest models, together with a context model that participates in the consistency relationships among these models. We illustrate this approach by using it to analyze the SKA system requirements.

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.

42 CFR 493.1289 - Standard: Analytic systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Analytic systems quality assessment. 493... Nonwaived Testing Analytic Systems § 493.1289 Standard: Analytic systems quality assessment. (a) The... through 493.1283. (b) The analytic systems quality assessment must include a review of the effectiveness...

42 CFR 493.1249 - Standard: Preanalytic systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Preanalytic systems quality assessment... Nonwaived Testing Preanalytic Systems § 493.1249 Standard: Preanalytic systems quality assessment. (a) The....1241 through 493.1242. (b) The preanalytic systems quality assessment must include a review of the...

40 CFR 90.327 - Sampling system requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Sampling system requirements. 90.327... Equipment Provisions § 90.327 Sampling system requirements. (a) Sample component surface temperature. For sampling systems which use heated components, use engineering judgment to locate the coolest portion of...

40 CFR 90.327 - Sampling system requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Sampling system requirements. 90.327... Equipment Provisions § 90.327 Sampling system requirements. (a) Sample component surface temperature. For sampling systems which use heated components, use engineering judgment to locate the coolest portion of...

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...

An Integrated Information System for Supporting Quality Management Tasks

NASA Astrophysics Data System (ADS)

Beyer, N.; Helmreich, W.

2004-08-01

In a competitive environment, well defined processes become the strategic advantage of a company. Hence, targeted Quality Management ensures efficiency, trans- parency and, ultimately, customer satisfaction. In the particular context of a Space Test Centre, a num- ber of specific Quality Management standards have to be applied. According to the revision of ISO 9001 dur- ing 2000, and due to the adaptation of ECSS-Q20-07, process orientation and data analysis are key tasks for ensuring and evaluating the efficiency of a company's processes. In line with these requirements, an integrated management system for accessing the necessary infor- mation to support Quality Management and other proc- esses has been established. Some of its test-related fea- tures are presented here. Easy access to the integrated management system from any work place at IABG's Space Test Centre is ensured by means of an intranet portal. It comprises a full set of quality-related process descriptions, information on test facilities, emergency procedures, and other relevant in- formation. The portal's web interface provides direct access to a couple of external applications. Moreover, easy updating of all information and low cost mainte- nance are features of this integrated information system. The timely and transparent management of non- conformances is covered by a dedicated NCR database which incorporates full documentation capability, elec- tronic signature and e-mail notification of concerned staff. A search interface allows for queries across all documented non-conformances. Furthermore, print ver- sions can be generated at any stage in the process, e.g. for distribution to customers. Feedback on customer satisfaction is sought through a web-based questionnaire. The process is initiated by the responsible test manager through submission of an e- mail that contains a hyperlink to a secure website, ask- ing the customer to complete the brief online form, which is directly fed to a database

46 CFR 63.20-1 - Specific control system requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Specific control system requirements. 63.20-1 Section 63... AUXILIARY BOILERS Additional Control System Requirements § 63.20-1 Specific control system requirements. In... following requirements apply for specific control systems: (a) Primary safety control system. Following...

46 CFR 63.20-1 - Specific control system requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Specific control system requirements. 63.20-1 Section 63... AUXILIARY BOILERS Additional Control System Requirements § 63.20-1 Specific control system requirements. In... following requirements apply for specific control systems: (a) Primary safety control system. Following...

Towards a Fuzzy Expert System on Toxicological Data Quality Assessment.

PubMed

Yang, Longzhi; Neagu, Daniel; Cronin, Mark T D; Hewitt, Mark; Enoch, Steven J; Madden, Judith C; Przybylak, Katarzyna

2013-01-01

Quality assessment (QA) requires high levels of domain-specific experience and knowledge. QA tasks for toxicological data are usually performed by human experts manually, although a number of quality evaluation schemes have been proposed in the literature. For instance, the most widely utilised Klimisch scheme1 defines four data quality categories in order to tag data instances with respect to their qualities; ToxRTool2 is an extension of the Klimisch approach aiming to increase the transparency and harmonisation of the approach. Note that the processes of QA in many other areas have been automatised by employing expert systems. Briefly, an expert system is a computer program that uses a knowledge base built upon human expertise, and an inference engine that mimics the reasoning processes of human experts to infer new statements from incoming data. In particular, expert systems have been extended to deal with the uncertainty of information by representing uncertain information (such as linguistic terms) as fuzzy sets under the framework of fuzzy set theory and performing inferences upon fuzzy sets according to fuzzy arithmetic. This paper presents an experimental fuzzy expert system for toxicological data QA which is developed on the basis of the Klimisch approach and the ToxRTool in an effort to illustrate the power of expert systems to toxicologists, and to examine if fuzzy expert systems are a viable solution for QA of toxicological data. Such direction still faces great difficulties due to the well-known common challenge of toxicological data QA that "five toxicologists may have six opinions". In the meantime, this challenge may offer an opportunity for expert systems because the construction and refinement of the knowledge base could be a converging process of different opinions which is of significant importance for regulatory policy making under the regulation of REACH, though a consensus may never be reached. Also, in order to facilitate the implementation

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

PubMed

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

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.

Integrated management of depression: improving system quality and creating effective interfaces.

PubMed

Myette, Thomas L

2008-04-01

Depression is a chronic recurrent condition and is a leading cause of work disability. Improving occupational outcomes for depression will require an integrated approach that incorporates best practices from the clinical, community, and workplace systems. This article briefly reviews recent quality improvement initiatives and promising practices in each system and then shifts to the importance of systems integration. An integrated chronic care model uses a sophisticated case management process to support essential relationships, facilitate key plans, and efficiently link the three systems to optimize clinical, economic, and occupational outcomes. An expanded role for employers and their agents in the management of depression and other chronic diseases is seen as fundamental to maintaining a healthy and productive workforce. To improve occupational outcomes for depression by integrating best practices from the clinical, community, and workplace systems. After a brief review of quality improvement initiatives and promising practices in each system, an integrated chronic care model is introduced. A case management process that links critical systems, supports essential relationships, and facilitates key plans is expected to result in improvements in clinical, economic, and occupational outcomes. Employers should be more engaged with clinical and community partners in the prevention and control of depression in affected employees.

Ethnopedology and soil quality of bamboo (Bambusa sp.) based agroforestry system.

PubMed

Arun Jyoti, Nath; Lal, Rattan; Das, Ashesh Kumar

2015-07-15

It is widely recognized that farmers' hold important knowledge of folk soil classification for agricultural land for its uses, yet little has been studied for traditional agroforestry systems. This article explores the ethnopedology of bamboo (Bambusa sp.) based agroforestry system in North East India, and establishes the relationship of soil quality index (SQI) with bamboo productivity. The study revealed four basic folk soil (mati) types: kalo (black soil), lal (red soil), pathal (stony soil) and balu (sandy soil). Of these, lal mati soil was the most predominant soil type (~ 40%) in bamboo-based agroforestry system. Soil physio-chemical parameters were studied to validate the farmers' soil hierarchal classification and also to correlate with productivity of the bamboo stand. Farmers' hierarchal folk soil classification was consistent with the laboratory scientific analysis. Culm production (i.e. measure of productivity of bamboo) was the highest (27culmsclump(-1)) in kalo mati (black soil) and the lowest (19culmsclump(-1)) in balu mati (sandy soil). Linear correlation of individual soil quality parameter with bamboo productivity explained 16 to 49% of the variability. A multiple correlation of the best fitted linear soil quality parameter (soil organic carbon or SOC, water holding capacity or WHC, total nitrogen) with productivity improved explanatory power to 53%. Development of SQI from ten relevant soil quality parameters and its correlation with bamboo productivity explained the 64% of the variation and therefore, suggest SQI as the best determinant of bamboo yield. Data presented indicate that the kalo mati (black soil) is sustainable or sustainable with high input. However, the other three folk soil types (red, stony and sandy soil) are also sustainable but for other land uses. Therefore, ethnopedological studies may move beyond routine laboratory analysis and incorporate SQI for assessing the sustainability of land uses managed by the farmers'. Additional

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…

Intelligent Systems Approaches to Product Sound Quality Analysis

NASA Astrophysics Data System (ADS)

Pietila, Glenn M.

As a product market becomes more competitive, consumers become more discriminating in the way in which they differentiate between engineered products. The consumer often makes a purchasing decision based on the sound emitted from the product during operation by using the sound to judge quality or annoyance. Therefore, in recent years, many sound quality analysis tools have been developed to evaluate the consumer preference as it relates to a product sound and to quantify this preference based on objective measurements. This understanding can be used to direct a product design process in order to help differentiate the product from competitive products or to establish an impression on consumers regarding a product's quality or robustness. The sound quality process is typically a statistical tool that is used to model subjective preference, or merit score, based on objective measurements, or metrics. In this way, new product developments can be evaluated in an objective manner without the laborious process of gathering a sample population of consumers for subjective studies each time. The most common model used today is the Multiple Linear Regression (MLR), although recently non-linear Artificial Neural Network (ANN) approaches are gaining popularity. This dissertation will review publicly available published literature and present additional intelligent systems approaches that can be used to improve on the current sound quality process. The focus of this work is to address shortcomings in the current paired comparison approach to sound quality analysis. This research will propose a framework for an adaptive jury analysis approach as an alternative to the current Bradley-Terry model. The adaptive jury framework uses statistical hypothesis testing to focus on sound pairings that are most interesting and is expected to address some of the restrictions required by the Bradley-Terry model. It will also provide a more amicable framework for an intelligent systems approach

Level of Adoption of Quality Management Systems Into the Mexican Pork Industry

NASA Astrophysics Data System (ADS)

Maldonado-Siman, Em; Ruíz-Flores, Agustín; Núñez-Domínguez, Rafael; González-Alcorta, Mariano; Hernández-Rodríguez, Bertha Alicia

This research studies the characteristics of the Mexican pork sector; adoption status of quality management systems, and product destinations. Ninety six percent of fifty enterprises have fully answered a questionnaire. Ninety percent are small and medium-sized, the rest are large-sized firms. Nineteen percent of them have totally adopted HACCP, sixty three percent are implementing or planning to do it, the rest have no plans to adopt it. Thirteen percent of the enterprises had ISO 9000. Thirty four percent of their sales go to supermarkets, 57% to other retail chains and 9% to exportation. Product destinations are mainly Central America, United States of America, Asia and Mexico. To improve efficiency and the quality of process it is necessary to implement HACCP. Besides, customers and legal requirements are the external factors, which result in this adoption. In the process of implementing, there are some problems, such as staff motivation and training. The results suggest that HACCP system operating is important for the Mexican pork industry. It also has relevant implications in domestic trade. It is necessary to encourage adoption of quality management systems in the sector.

Requirements controlled design: A method for discovery of discontinuous system boundaries in the requirements hyperspace

NASA Astrophysics Data System (ADS)

Hollingsworth, Peter Michael

The drive toward robust systems design, especially with respect to system affordability throughout the system life-cycle, has led to the development of several advanced design methods. While these methods have been extremely successful in satisfying the needs for which they have been developed, they inherently leave a critical area unaddressed. None of them fully considers the effect of requirements on the selection of solution systems. The goal of all of current modern design methodologies is to bring knowledge forward in the design process to the regions where more design freedom is available and design changes cost less. Therefore, it seems reasonable to consider the point in the design process where the greatest restrictions are placed on the final design, the point in which the system level requirements are set. Historically the requirements have been treated as something handed down from above. However, neither the customer nor the solution provider completely understood all of the options that are available in the broader requirements space. If a method were developed that provided the ability to understand the full scope of the requirements space, it would allow for a better comparison of potential solution systems with respect to both the current and potential future requirements. The key to a requirements conscious method is to treat requirements differently from the traditional approach. The method proposed herein is known as Requirements Controlled Design (RCD). By treating the requirements as a set of variables that control the behavior of the system, instead of variables that only define the response of the system, it is possible to determine a-priori what portions of the requirements space that any given system is capable of satisfying. Additionally, it should be possible to identify which systems can satisfy a given set of requirements and the locations where a small change in one or more requirements poses a significant risk to a design program

A review of data quality assessment methods for public health information systems.

PubMed

Chen, Hong; Hailey, David; Wang, Ning; Yu, Ping

2014-05-14

High quality data and effective data quality assessment are required for accurately evaluating the impact of public health interventions and measuring public health outcomes. Data, data use, and data collection process, as the three dimensions of data quality, all need to be assessed for overall data quality assessment. We reviewed current data quality assessment methods. The relevant study was identified in major databases and well-known institutional websites. We found the dimension of data was most frequently assessed. Completeness, accuracy, and timeliness were the three most-used attributes among a total of 49 attributes of data quality. The major quantitative assessment methods were descriptive surveys and data audits, whereas the common qualitative assessment methods were interview and documentation review. The limitations of the reviewed studies included inattentiveness to data use and data collection process, inconsistency in the definition of attributes of data quality, failure to address data users' concerns and a lack of systematic procedures in data quality assessment. This review study is limited by the coverage of the databases and the breadth of public health information systems. Further research could develop consistent data quality definitions and attributes. More research efforts should be given to assess the quality of data use and the quality of data collection process.

A Review of Data Quality Assessment Methods for Public Health Information Systems

PubMed Central

Chen, Hong; Hailey, David; Wang, Ning; Yu, Ping

2014-01-01

High quality data and effective data quality assessment are required for accurately evaluating the impact of public health interventions and measuring public health outcomes. Data, data use, and data collection process, as the three dimensions of data quality, all need to be assessed for overall data quality assessment. We reviewed current data quality assessment methods. The relevant study was identified in major databases and well-known institutional websites. We found the dimension of data was most frequently assessed. Completeness, accuracy, and timeliness were the three most-used attributes among a total of 49 attributes of data quality. The major quantitative assessment methods were descriptive surveys and data audits, whereas the common qualitative assessment methods were interview and documentation review. The limitations of the reviewed studies included inattentiveness to data use and data collection process, inconsistency in the definition of attributes of data quality, failure to address data users’ concerns and a lack of systematic procedures in data quality assessment. This review study is limited by the coverage of the databases and the breadth of public health information systems. Further research could develop consistent data quality definitions and attributes. More research efforts should be given to assess the quality of data use and the quality of data collection process. PMID:24830450

40 CFR 63.11890 - What are my additional general requirements for complying with this subpart?

Code of Federal Regulations, 2012 CFR

2012-07-01

... malfunctions and required monitoring system quality assurance or quality control activities (including, as... malfunctions, or required monitoring system quality assurance or control activities in calculations used to... source, including associated air pollution control components and monitoring system components, in a...

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...

The relationship between social capital and quality management systems in European hospitals: a quantitative study.

PubMed

Hammer, Antje; Arah, Onyebuchi A; Dersarkissian, Maral; Thompson, Caroline A; Mannion, Russell; Wagner, Cordula; Ommen, Oliver; Sunol, Rosa; Pfaff, Holger

2013-01-01

Strategic leadership is an important organizational capability and is essential for quality improvement in hospital settings. Furthermore, the quality of leadership depends crucially on a common set of shared values and mutual trust between hospital management board members. According to the concept of social capital, these are essential requirements for successful cooperation and coordination within groups. We assume that social capital within hospital management boards is an important factor in the development of effective organizational systems for overseeing health care quality. We hypothesized that the degree of social capital within the hospital management board is associated with the effectiveness and maturity of the quality management system in European hospitals. We used a mixed-method approach to data collection and measurement in 188 hospitals in 7 European countries. For this analysis, we used responses from hospital managers. To test our hypothesis, we conducted a multilevel linear regression analysis of the association between social capital and the quality management system score at the hospital level, controlling for hospital ownership, teaching status, number of beds, number of board members, organizational culture, and country clustering. The average social capital score within a hospital management board was 3.3 (standard deviation: 0.5; range: 1-4) and the average hospital score for the quality management index was 19.2 (standard deviation: 4.5; range: 0-27). Higher social capital was associated with higher quality management system scores (regression coefficient: 1.41; standard error: 0.64, p=0.029). The results suggest that a higher degree of social capital exists in hospitals that exhibit higher maturity in their quality management systems. Although uncontrolled confounding and reverse causation cannot be completely ruled out, our new findings, along with the results of previous research, could have important implications for the work of

Talking about quality: exploring how 'quality' is conceptualized in European hospitals and healthcare systems.

PubMed

Wiig, Siri; Aase, Karina; von Plessen, Christian; Burnett, Susan; Nunes, Francisco; Weggelaar, Anne Marie; Anderson-Gare, Boel; Calltorp, Johan; Fulop, Naomi

2014-10-11

Conceptualization of quality of care - in terms of what individuals, groups and organizations include in their meaning of quality, is an unexplored research area. It is important to understand how quality is conceptualised as a means to successfully implement improvement efforts and bridge potential disconnect in language about quality between system levels, professions, and clinical services. The aim is therefore to explore and compare conceptualization of quality among national bodies (macro level), senior hospital managers (meso level), and professional groups within clinical micro systems (micro level) in a cross-national study. This cross-national multi-level case study combines analysis of national policy documents and regulations at the macro level with semi-structured interviews (383) and non-participant observation (803 hours) of key meetings and shadowing of staff at the meso and micro levels in ten purposively sampled European hospitals (England, the Netherlands, Portugal, Sweden, and Norway). Fieldwork at the meso and micro levels was undertaken over a 12-month period (2011-2012) and different types of micro systems were included (maternity, oncology, orthopaedics, elderly care, intensive care, and geriatrics). The three quality dimensions clinical effectiveness, patient safety, and patient experience were incorporated in macro level policies in all countries. Senior hospital managers adopted a similar conceptualization, but also included efficiency and costs in their conceptualization of quality. 'Quality' in the forms of measuring indicators and performance management were dominant among senior hospital managers (with clinical and non-clinical background). The differential emphasis on the three quality dimensions was strongly linked to professional roles, personal ideas, and beliefs at the micro level. Clinical effectiveness was dominant among physicians (evidence-based approach), while patient experience was dominant among nurses (patient

Fit for purpose quality management system for military forensic exploitation.