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...

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...

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

Code of Federal Regulations, 2013 CFR

2013-07-01

... monitoring system quality assurance or quality control activities (including, as applicable, calibration... required monitoring system quality assurance or quality control activities including, as applicable... required monitoring system quality assurance or control activities in calculations used to report emissions...

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...

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...

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...

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2012 CFR

2012-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2013 CFR

2013-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2011 CFR

2011-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2014 CFR

2014-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Quality assurance tendering and awarding contracts

NASA Astrophysics Data System (ADS)

1994-12-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 51.359 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Quality control. 51.359 Section 51.359 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS REQUIREMENTS FOR... to assure test accuracy. Computer control of quality assurance checks and quality control charts...

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.

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

42 CFR 84.40 - Quality control plans; filing requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality... proposed quality control plan which shall be designed to assure the quality of respiratory protection...

7 CFR 275.21 - Quality control review reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 4 2011-01-01 2011-01-01 false Quality control review reports. 275.21 Section 275.21... Reporting on Program Performance § 275.21 Quality control review reports. (a) General. Each State agency shall submit reports on the performance of quality control reviews in accordance with the requirements...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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...

42 CFR 423.162 - Quality improvement organization activities.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 3 2012-10-01 2012-10-01 false Quality improvement organization activities. 423... Cost Control and Quality Improvement Requirements § 423.162 Quality improvement organization activities. (a) General rule. Quality improvement organizations (QIOs) are required to offer providers...

42 CFR 423.162 - Quality improvement organization activities.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 3 2014-10-01 2014-10-01 false Quality improvement organization activities. 423... Cost Control and Quality Improvement Requirements § 423.162 Quality improvement organization activities. (a) General rule. Quality improvement organizations (QIOs) are required to offer providers...

42 CFR 423.162 - Quality improvement organization activities.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 3 2013-10-01 2013-10-01 false Quality improvement organization activities. 423... Cost Control and Quality Improvement Requirements § 423.162 Quality improvement organization activities. (a) General rule. Quality improvement organizations (QIOs) are required to offer providers...

40 CFR 63.8615 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2010 CFR

2010-07-01

... monitoring malfunctions, associated repairs, out-of-control periods, or required quality assurance or control activities for purposes of calculating data averages. A monitoring malfunction is any sudden, infrequent, not... periods of monitor malfunctions, associated repairs, and required quality assurance or control activities...

Total quality assurance

NASA Astrophysics Data System (ADS)

Louzon, E.

1989-12-01

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

46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

Principles and Practices for Quality Assurance and Quality Control

USGS Publications Warehouse

Jones, Berwyn E.

1999-01-01

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

Quality program plan for the Ultraviolet Spectrometer Experiment S169, Revision C

NASA Technical Reports Server (NTRS)

Vinson, W. W.

1971-01-01

The quality progress plan establishes the requirements for a system of controls to assure compliance with the quality assurance requirements as set forth in NASA quality program provisions for aeronautical and space system contractors.

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...

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

PubMed

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

2011-12-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

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...

42 CFR 475.101 - Eligibility requirements for QIO contracts.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 475.101 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS QUALITY IMPROVEMENT ORGANIZATIONS Utilization and Quality Control Quality Improvement Organizations § 475.101 Eligibility requirements for QIO contracts. In...

23 CFR 1340.8 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

23 CFR 1340.8 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

23 CFR 1340.8 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

Family Functions and Life Quality of Parents of Children With Cleft Lip and Palate.

PubMed

Aslan, Belma I; Gülşen, Ayşe; Tirank, Şadiye B; Findikçioğlu, Kemal; Uzuner, F Deniz; Tutar, Hakan; Üçüncü, Neslihan

2018-05-15

This study was designed to identify variables affecting family functions and life quality of parents with cleft lip and/or palate children. Family Assesment Scale (FAS) and short form of World Health Organization quality of life (WHOQOL-BREF-TR) were used to measure family functions and life quality of parents. Questionnaire Forms were given to 146 parents: 74 having cleft lip and/or palate children (cleft-group), and the other 72 with healthy children (control-group). Parents were divided into 3 subgroups according to children's age as 0 to 6, 7 to 12, and 13 to 18 years. Kruskal-Wallis and Mann-Whitney U tests were used to evaluate differences between the groups. Behavior of cleft patients' parents was found to be problematic in behavioral control, required attention and role areas at 0 to 6 years, required attention area at ages 7 to 12 and 13 to 18 years. When compared to control group, significant differences were detected in required attention at ages 0 to 6 years, problem-solving, and communication areas at 7 to 12 years. Findings of life quality were found to be over medium level in physical, social, psychological and environmental areas in cleft group at all age groups; however, life quality was found better in control group in physical, psychological, and social subtests at age 13 to 18 years. Cleft children influence family functions in behavioral control, required attention and role areas at early childhood, and continue to affect required attention through adolescence. Also social, physical, and psychological fields of life quality were found lower in cleft parents compared to control group at adolescence.

42 CFR 475.104 - Requirements for demonstrating ability to perform review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... review. 475.104 Section 475.104 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS QUALITY IMPROVEMENT ORGANIZATIONS Utilization and Quality Control Quality Improvement Organizations § 475.104 Requirements for demonstrating...

77 FR 73611 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

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

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-01

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

42 CFR 493.643 - Fee for determination of program compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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.

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

PubMed

Al-Qatawneh, Lina

2017-02-13

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

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

EPA Science Inventory

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

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...

Advancement in modern approaches to mineral production quality control

NASA Astrophysics Data System (ADS)

Freidina, EV; Botvinnik, AA; Dvornikova, AN

2017-02-01

The natural resource potential of mineral deposits is represented by three categories: upside, attainable and investment. A modern methodology is proposed in this paper for production quality control, and its tools aimed at ensuring agreement between the product quality and the market requirements are described. The definitions of the costs of the product quality compliance and incompliance with the consumer requirements are introduced; the latter is suggested to use in evaluating resource potential of mineral deposits at a certain degree of probability.

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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...

77 FR 75968 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... information unless it displays a currently valid OMB control number. Food and Nutrition Service Title: Quality... required to perform Quality Control (QC) review for the Supplemental Nutrition Assistance Program (SNAP). The FNS-380-1, Quality Control Review Schedule is for State use to collect both QC data and case...

Applying Sigma Metrics to Reduce Outliers.

PubMed

Litten, Joseph

2017-03-01

Sigma metrics can be used to predict assay quality, allowing easy comparison of instrument quality and predicting which tests will require minimal quality control (QC) rules to monitor the performance of the method. A Six Sigma QC program can result in fewer controls and fewer QC failures for methods with a sigma metric of 5 or better. The higher the number of methods with a sigma metric of 5 or better, the lower the costs for reagents, supplies, and control material required to monitor the performance of the methods. Copyright © 2016 Elsevier Inc. All rights reserved.

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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.

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

Educational Auditing and Quality Assurance. Occasional Paper No. 4.

ERIC Educational Resources Information Center

Conner, James E.; Lessinger, Leon M.

This paper considers how to respond to new requirements for adequate disclosure of the schools' performance to the public. It proposes the use of three powerful constructs--quality control, quality assurance, and an independent educational accomplishment audit (IEAA). The essential elements of quality control are agreeing on and specifying desired…

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

PubMed

2014-06-10

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

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

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

Code of Federal Regulations, 2012 CFR

2012-07-01

... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

Code of Federal Regulations, 2010 CFR

2010-07-01

... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

Code of Federal Regulations, 2011 CFR

2011-07-01

... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

Code of Federal Regulations, 2013 CFR

2013-07-01

... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

Code of Federal Regulations, 2014 CFR

2014-07-01

... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

49 CFR 173.474 - Quality control for construction of packaging.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 2 2011-10-01 2011-10-01 false Quality control for construction of packaging. 173...-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS Class 7 (Radioactive) Materials § 173.474 Quality control for construction of packaging. Prior to the first use of any packaging for the shipment of Class 7...

49 CFR 173.474 - Quality control for construction of packaging.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Quality control for construction of packaging. 173...-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS Class 7 (Radioactive) Materials § 173.474 Quality control for construction of packaging. Prior to the first use of any packaging for the shipment of Class 7...

[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.

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2014 CFR

2014-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

42 CFR 431.810 - Basic elements of the Medicaid eligibility quality control (MEQC) program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Basic elements of the Medicaid eligibility quality control (MEQC) program. 431.810 Section 431.810 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... elements of the Medicaid eligibility quality control (MEQC) program. (a) General requirements. The agency...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

ER quality control components UGGT and STT3a are required for activation of defense responses in bir1-1.

PubMed

Zhang, Qian; Sun, Tongjun; Zhang, Yuelin

2015-01-01

The receptor-like kinase SUPPRESSOR OF BIR1, 1 (SOBIR1) functions as a critical regulator in plant immunity. It is required for activation of cell death and defense responses in Arabidopsis bak1-interacting receptor-like kinase 1,1 (bir1-1) mutant plants. Here we report that the ER quality control component UDP-glucose:glycoprotein glucosyltransferase (UGGT) is required for the biogenesis of SOBIR1 and mutations in UGGT suppress the spontaneous cell death and constitutive defense responses in bir1-1. Loss of function of STT3a, which encodes a subunit of the oligosaccharyltransferase complex, also suppresses the autoimmune phenotype in bir1-1. However, it has no effect on the accumulation of SOBIR1, suggesting that additional signaling components other than SOBIR1 may be regulated by ER quality control. Our study provides clear evidence that ER quality control play critical roles in regulating defense activation in bir1-1.

21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

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 packaging and labeling operations? 111.127 Section 111.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING...

Assessment of flying-quality criteria for air-breathing aerospacecraft

NASA Technical Reports Server (NTRS)

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

1992-01-01

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

Manufacture and quality control of interconnecting wire hardnesses, Volume 1

NASA Technical Reports Server (NTRS)

1972-01-01

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

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

PubMed

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

2018-06-01

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

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 35.588 - Award limitations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Tribe or Intertribal Consortium meets the applicable quality assurance and quality control requirements... Intertribal Consortium agrees to include a discussion of how the work performed under section 106 addressed water quality problems on Tribal lands in the annual report required under § 35.515(d). (5) After an...

40 CFR 35.588 - Award limitations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Tribe or Intertribal Consortium meets the applicable quality assurance and quality control requirements... Intertribal Consortium agrees to include a discussion of how the work performed under section 106 addressed water quality problems on Tribal lands in the annual report required under § 35.515(d). (5) After an...

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.

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

NASA Technical Reports Server (NTRS)

Biezad, Daniel

1997-01-01

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

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

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.

Accreditation of Individualized Quality Control Plans by the College of American Pathologists.

PubMed

Hoeltge, Gerald A

2017-03-01

The Laboratory Accreditation Program of the College of American Pathologists (CAP) began in 2015 to allow accredited laboratories to devise their own strategies for quality control of laboratory testing. Participants now have the option to implement individualized quality control plans (IQCPs). Only nonwaived testing that features an internal control (built-in, electronic, or procedural) is eligible for IQCP accreditation. The accreditation checklists that detail the requirements have been peer-reviewed by content experts on CAP's scientific resource committees and by a panel of accreditation participants. Training and communication have been key to the successful introduction of the new IQCP requirements. Copyright © 2016 Elsevier Inc. All rights reserved.

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality... equipment procedures and records and to interview the employees who conduct the control tests. Two copies of...

40 CFR 63.10010 - What are my monitoring, installation, operation, and maintenance requirements?

Code of Federal Regulations, 2013 CFR

2013-07-01

... that emissions are controlled with a common control device or series of control devices, are discharged... parallel control devices or multiple series of control devices are discharged to the atmosphere through... quality control activities (including, as applicable, calibration checks and required zero and span...

40 CFR 63.10010 - What are my monitoring, installation, operation, and maintenance requirements?

Code of Federal Regulations, 2014 CFR

2014-07-01

... that emissions are controlled with a common control device or series of control devices, are discharged... parallel control devices or multiple series of control devices are discharged to the atmosphere through... quality control activities (including, as applicable, calibration checks and required zero and span...

78 FR 28854 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... formula regulations, including infant formula labeling, quality control procedures, notification....S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

Identification of milling and baking quality QTL in multiple soft wheat mapping populations

USDA-ARS?s Scientific Manuscript database

Wheat derived food products require a range of characteristics. Identification and understanding of the genetic components controlling end-use quality of wheat is important for crop improvement. We assessed the underlying genetics controlling specific milling and baking quality parameters of soft wh...

78 FR 22785 - Approval and Promulgation of Air Quality Implementation Plans; Delaware, State Board Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Promulgation of Air Quality Implementation Plans; Delaware, State Board Requirements AGENCY: Environmental... revision to the Delaware State Implementation Plan (SIP) submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) on January 11, 2013. The SIP revision addresses requirements of...

23 CFR 637.207 - Quality assurance program.

Code of Federal Regulations, 2011 CFR

2011-04-01

... independent assurance (IA) program consisting of the following: (1) Acceptance program. (i) Each STD's... quality control samples. (C) The quality control sampling and testing is evaluated by an IA program. (iii... appropriate. See 23 CFR 635.413(e) for specific requirements. (2) The IA program shall evaluate the qualified...

75 FR 23777 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... collection regarding the manufacture of infant formula, including infant formula labeling, quality control.... 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-22

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

References on EPA Quality Assurance Project Plans

EPA Pesticide Factsheets

Provides requirements for the conduct of quality management practices, including quality assurance (QA) and quality control (QC) activities, for all environmental data collection and environmental technology programs performed by or for this Agency.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

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

42 CFR 493.1425 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

Measuring Software Product Quality: The ISO 25000 Series and CMMI

DTIC Science & Technology

2004-06-14

performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

Quality control education in the community college

NASA Technical Reports Server (NTRS)

Greene, J. Griffen; Wilson, Steve

1966-01-01

This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

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

DTIC Science & Technology

1998-05-18

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

Evaluation of the Flying Qualities Requirements of MIL-F-8785B (ASG) using the C-5A Airplane

DTIC Science & Technology

1975-03-20

using only the elevator control (neutralizing the aileron and rudder controls is allowed). The same tech - nique used to recover from post-stall gyrations...AD-AO11 728 EVALUATION OF THE FLYING QUALITIES REQUIREMENTS OF MIL- F-8785B (ASG) USING THE C-5A AIRPLANE Charles L. Silvers, et al Lockheed-Geor-gia...75-3 00 EVALUATION OF THE FLYING QUALITIES •- ~REQUIRIMENTS OF MIL-F-878S5 (ASO) USING THE C-SA AIRPLANE LOCKHEED-GEORGIA COMPANY TECHNICAL REPORT

User Interaction with the CNPC Link

NASA Technical Reports Server (NTRS)

Hobbs, Alan; Lyall, Elizabeth A.

2014-01-01

As part of NASAs UAS in the NAS project, human factor guidelines are being developed for the ground control station of unmanned aircraft systems. A critical task for the pilot of a UAS is the management and control of the terrestrial radio links used to provide control of the vehicle and relay communications with air traffic control. An analysis of the task of the UAS pilot has been conducted to identify areas where guidelines are required. This analysis has identified a set of information requirements that must be supported by the radio equipment used to provide Control and Non-payload Communication (CNPC). Key requirements include the need for an alert when the link is lost, information on the current quality and latency of the link, and information to enable the future quality of the link to be anticipated as the aircraft changes location. These identified requirements can assist in the development of minimum operational performance standards for CNPC equipment.

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

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

77 FR 62147 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Pittsburgh-Beaver...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... completeness requirement for one or more quarters during 2009-2011. EPA addressed the missing data of each of...-assured, quality-controlled and certified ambient air monitoring data for the 2008-2010 and 2009-2011...- assured, quality-controlled, and certified monitoring data for the 2007-2009 monitoring period, that the...

75 FR 59084 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control Technique...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... Promulgation of Air Quality Implementation Plans; Maryland; Control Technique Guidelines for Paper, Film, and... from paper, film, and foil coatings. Specifically, Maryland is amending its regulations by adopting the requirements of EPA's Control Technique Guidelines (CTG) for Paper, Film, and Foil Coatings. These amendments...

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...

Data Validation & Laboratory Quality Assurance for Region 9

EPA Pesticide Factsheets

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

Effects of side-stick controllers on rotorcraft handling qualities for terrain flight

NASA Technical Reports Server (NTRS)

Aiken, E. W.

1985-01-01

Pertinent fixed and rotary-wing feasibility studies and handling-qualities research programs are reviewed and the effects of certain controller characteristics on handling qualities for specific rotorcraft flight tasks are summarized. The effects of the controller force-deflection relationship and the number of controlled axes that are integrated in a single controller are examined. Simulation studies were conducted which provide a significant part of the available handling qualities data. The studies demonstrate the feasibility of using a single, properly designed, limited-displacement, multiaxis controller for certain relatively routine flight tasks in a two-crew rotorcraft with nominal levels of stability and control augmentation with a high degree of reliability are incorporated, separated three or two-axis controller configurations are required for acceptable handling qualities.

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160... procedures, or other laboratory control mechanisms required by this subpart, including any change in such...

Bioassay selection, experimental design and quality control/assurance for use in effluent assessment and control.

PubMed

Johnson, Ian; Hutchings, Matt; Benstead, Rachel; Thain, John; Whitehouse, Paul

2004-07-01

In the UK Direct Toxicity Assessment Programme, carried out in 1998-2000, a series of internationally recognised short-term toxicity test methods for algae, invertebrates and fishes, and rapid methods (ECLOX and Microtox) were used extensively. Abbreviated versions of conventional tests (algal growth inhibition tests, Daphnia magna immobilisation test and the oyster embryo-larval development test) were valuable for toxicity screening of effluent discharges and the identification of causes and sources of toxicity. Rapid methods based on chemiluminescence and bioluminescence were not generally useful in this programme, but may have a role where the rapid test has been shown to be an acceptable surrogate for a standardised test method. A range of quality assurance and control measures were identified. Requirements for quality control/assurance are most stringent when deriving data for characterising the toxic hazards of effluents and monitoring compliance against a toxicity reduction target. Lower quality control/assurance requirements can be applied to discharge screening and the identification of causes and sources of toxicity.

QUALITY CONTROL OF PHARMACEUTICALS.

PubMed

LEVI, L; WALKER, G C; PUGSLEY, L I

1964-10-10

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed.

[Quality control in anesthesiology].

PubMed

Muñoz-Ramón, J M

1995-03-01

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

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

PubMed

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

48 CFR 2146.201 - General.

Code of Federal Regulations, 2012 CFR

2012-10-01

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

48 CFR 2146.201 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

48 CFR 2146.201 - General.

Code of Federal Regulations, 2013 CFR

2013-10-01

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

48 CFR 2146.201 - General.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

48 CFR 2146.201 - General.

Code of Federal Regulations, 2014 CFR

2014-10-01

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

42 CFR 480.106 - Exceptions to QIO notice requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 480.106 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION REVIEW INFORMATION Utilization and Quality Control Quality Improvement Organizations...

42 CFR 480.106 - Exceptions to QIO notice requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs... public health. When the QIO determines that requested information is necessary to protect against an...

42 CFR 480.106 - Exceptions to QIO notice requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION REVIEW INFORMATION Utilization and Quality Control Quality Improvement Organizations... individuals or public health. When the QIO determines that requested information is necessary to protect...

42 CFR 480.106 - Exceptions to QIO notice requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs... public health. When the QIO determines that requested information is necessary to protect against an...

42 CFR 480.106 - Exceptions to QIO notice requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs... public health. When the QIO determines that requested information is necessary to protect against an...

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

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

[Preparation of freeze - drying control materials of IgG antibody against Schistosoma japonicum for immunodetection kits].

PubMed

Jin, Huang; Chun-Lian, Tang; Zu-Wu, Tu; Li, Tang; Ke-Hui, Zhang; Qian, Li; Jun, Ye

2018-04-18

To prepare freeze-drying control materials of IgG antibody against Schistosoma japonicum for detection kits. The serum samples of schistosomiasis patients from endemic areas and normal people without history of schistosome infection or contact with infested water in Hubei Province were collected. All the sera were detected by the method approved by China Food and Drug Administration and selected for preparation of quality control samples. Totally twelve positive quality control materials, ten negative quality control materials, and one sensitive and one precision quality control materials were screened. According to the positive serum level, the positive degrees of quality control materials were divided into strong, medium and weak levels. The stability could be valid for one year. The freeze-drying quality control materials of IgG antibody against S. japonicum for detection kits are prepared. They are easy to use and have good stability, and therefore, they may meet the requirement of quality control for the detection of schistosomiasis diagnostics kits.

Quality management in in vivo proton MRS.

PubMed

Pedrosa de Barros, Nuno; Slotboom, Johannes

2017-07-15

The quality of MR-Spectroscopy data can easily be affected in in vivo applications. Several factors may produce signal artefacts, and often these are not easily detected, not even by experienced spectroscopists. Reliable and reproducible in vivo MRS-data requires the definition of quality requirements and goals, implementation of measures to guarantee quality standards, regular control of data quality, and a continuous search for quality improvement. The first part of this review includes a general introduction to different aspects of quality management in MRS. It is followed by the description of a series of tests and phantoms that can be used to assure the quality of the MR system. In the third part, several methods and strategies used for quality control of the spectroscopy data are presented. This review concludes with a reference to a few interesting techniques and aspects that may help to further improve the quality of in vivo MR-spectra. Copyright © 2017 Elsevier Inc. All rights reserved.

42 CFR 493.1495 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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

ERIC Educational Resources Information Center

Haapakorpi, Arja; Geirsdóttir, Guðrún; Jóhannsdóttir, Gyða

2013-01-01

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

Statistical Methods in Assembly Quality Management of Multi-Element Products on Automatic Rotor Lines

NASA Astrophysics Data System (ADS)

Pries, V. V.; Proskuriakov, N. E.

2018-04-01

To control the assembly quality of multi-element mass-produced products on automatic rotor lines, control methods with operational feedback are required. However, due to possible failures in the operation of the devices and systems of automatic rotor line, there is always a real probability of getting defective (incomplete) products into the output process stream. Therefore, a continuous sampling control of the products completeness, based on the use of statistical methods, remains an important element in managing the quality of assembly of multi-element mass products on automatic rotor lines. The feature of continuous sampling control of the multi-element products completeness in the assembly process is its breaking sort, which excludes the possibility of returning component parts after sampling control to the process stream and leads to a decrease in the actual productivity of the assembly equipment. Therefore, the use of statistical procedures for continuous sampling control of the multi-element products completeness when assembled on automatic rotor lines requires the use of such sampling plans that ensure a minimum size of control samples. Comparison of the values of the limit of the average output defect level for the continuous sampling plan (CSP) and for the automated continuous sampling plan (ACSP) shows the possibility of providing lower limit values for the average output defects level using the ACSP-1. Also, the average sample size when using the ACSP-1 plan is less than when using the CSP-1 plan. Thus, the application of statistical methods in the assembly quality management of multi-element products on automatic rotor lines, involving the use of proposed plans and methods for continuous selective control, will allow to automating sampling control procedures and the required level of quality of assembled products while minimizing sample size.

KPMG Peat Marwick LLP Corporation of Mercer University Fiscal Year Ended June 30, 1995

DTIC Science & Technology

1997-06-11

The objective of a quality control review is to ensure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-133. We conducted a quality control review of the audit working papers. We focused our review on the following...qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control, internal controls, substantive testing, general and specific compliance testing, and the Schedule of Federal Awards.

75 FR 15348 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revision To Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

.... What Is a SIP? Section 110 of the CAA requires states to develop air pollution regulations and control... air pollution regulations, control strategies, other means or techniques, and technical analyses... provisions of the CAA. A SIP protects air quality primarily by addressing air pollution at its point of...

[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.

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

INTEGRATING PROBABILISTIC AND FIXED-SITE MONITORING FOR ROBUST WATER QUALITY ASSESSMENTS

EPA Science Inventory

Determining the extent of water-quality degradation, controlling nonpoint sources, and defining allowable amounts of contaminants are important water-quality issues defined in the Clean Water Act that require new monitoring data. Probabilistic, randomized stream water-quality mon...

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

PubMed

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

2010-01-01

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

A simulation investigation of scout/attack helicopter directional control requirements for hover and low-speed tasks

NASA Technical Reports Server (NTRS)

Bivens, Courtland C.; Guercio, Joseph G.

1987-01-01

A piloted simulator experiment was conducted to investigate directional axis handling qualities requirements for low speed and hover tasks performed by a Scout/Attack helicopter. Included were the directional characteristics of various candidate light helicopter family configurations. Also, the experiment focused on conventional single main/tail rotor configurations of the OH-58 series aircraft, where the first-order yaw-axis dynamic effects that contributed to the loss of tail rotor control were modeled. Five pilots flew 22 configurations under various wind conditions. Cooper-Harper handling quality ratings were used as the primary measure of merit of each configuration. The results of the experiment indicate that rotorcraft configurations with high directional gust sensitivity require greater minimum yaw damping to maintain satisfactory handling qualities during nap-of-the-Earth flying tasks. It was also determined that both yaw damping and control response are critical handling qualities parameters in performing the air-to-air target acquisition and tracking task. Finally, the lack of substantial yaw damping and larger values of gust sensitivity increased the possibility of loss of directional control at low airspeeds for the single main/tail rotor configurations.

Ernst and Young LLP South Carolina Research Authority Fiscal Year Ended June 30, 1995.

DTIC Science & Technology

1997-06-30

The objective of a quality control review is to ensure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of OMB Circular A-133. As the Federal oversight agency for SCRA, we conducted a quality control review of the audit working papers. We...focused our review on the following qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control

Quality Control of Pharmaceuticals

PubMed Central

Levi, Leo; Walker, George C.; Pugsley, L. I.

1964-01-01

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed. PMID:14199105

FIELD QUALITY CONTROL STRATEGIES ASSESSING SOLIDIFICATION/STABILIZATION

EPA Science Inventory

Existing regulatory mobility reduction (leaching) tests are not amenable to real time quality control because of the time required to perform sample extraction and chemical analysis. This is of conccern because the leaching test is the most important parameter used to relate trea...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2010 CFR

2010-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2013 CFR

2013-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2014 CFR

2014-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2012 CFR

2012-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

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

DOT National Transportation Integrated Search

2015-01-01

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

Progressing quality control in environmental impact assessment beyond legislative compliance: An evaluation of the IEMA EIA Quality Mark certification scheme

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

Bond, Alan, E-mail: alan.bond@uea.ac.uk; Research Unit for Environmental Sciences and Management, North-West University; Fischer, Thomas B, E-mail: fischer@liverpool.ac.uk

The effectiveness of Environmental Impact Assessment (EIA) systems is contingent on a number of control mechanisms: procedural; judicial; evaluative; public and government agency; professional; and development aid agency. If we assume that procedural and judicial controls are guaranteed in developed EIA systems, then progressing effectiveness towards an acceptable level depends on improving the performance of other control mechanisms over time. These other control mechanisms are either absent, or are typically centrally controlled, requiring public finances; this we argue is an unpopular model in times of greater Government austerity. Here we evaluate a market-based mechanism for improving the performance of evaluativemore » and professional control mechanisms, the UK Institute of Environmental Management and Assessments' EIA Quality Mark. We do this by defining dimensions of effectiveness for the purposes of our evaluation, and by identifying international examples of the approaches taken to delivering the other control measures to validate the approach taken in the EIA Quality Mark. We then evaluate the EIA Quality Mark, when used in combination with legal procedures and an active judiciary, against the effectiveness dimensions and use time-series analysis of registrant data to examine its ability to progress practice. We conclude that the EIA Quality Mark has merit as a model for a market-based mechanism, and may prove a more financially palatable approach for delivering effective EIA in mature systems in countries that lack centralised agency oversight. It may, therefore, be of particular interest to some Member States of the European Union for ensuring forthcoming certification requirements stemming from recent amendments to the EIA Directive. - Highlights: • Quality control mechanisms in EIA are identified. • Effectiveness of EIA is conceptualised for evaluation purposes. • The UK IEMA EIA Quality Mark is introduced as a market-based mechanism. • The EIA Quality Mark is found to progress quality in many, but not all, areas.« less

A pilot's assessment of helicopter handling-quality factors common to both agility and instrument flying tasks

NASA Technical Reports Server (NTRS)

Gerdes, R. M.

1980-01-01

A series of simulation and flight investigations were undertaken to evaluate helicopter flying qualities and the effects of control system augmentation for nap-of-the-Earth (NOE) agility and instrument flying tasks. Handling quality factors common to both tasks were identified. Precise attitude control was determined to be a key requirement for successful accomplishment of both tasks. Factors that degraded attitude controllability were improper levels of control sensitivity and damping, and rotor system cross coupling due to helicopter angular rate and collective pitch input. Application of rate command, attitude command, and control input decouple augmentation schemes enhanced attitude control and significantly improved handling qualities for both tasks. The NOE agility and instrument flying handling quality considerations, pilot rating philosophy, and supplemental flight evaluations are also discussed.

GEOSPATIAL QUALITY COUNCIL

EPA Science Inventory

Geospatial Science is increasingly becoming an important tool in making Agency decisions. QualIty Control and Quality Assurance are required to be integrated during the planning, implementation and assessment of geospatial databases, processes and products. In order to ensure Age...

Quality in the Professions.

ERIC Educational Resources Information Center

Becher, Tony

1999-01-01

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

78 FR 8485 - Approval and Promulgation of Air Quality Implementation Plans; Michigan

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... Promulgation of Air Quality Implementation Plans; Michigan AGENCY: Environmental Protection Agency (EPA... control), R336.1240 (Required air quality models), R336.1241 (Air quality modeling demonstration... nonattainment air quality permitting regulations found in 40 CFR 51.165(a) and (b). EPA has found that the rules...

40 CFR 63.8465 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2010 CFR

2010-07-01

... use data recorded during monitoring malfunctions, associated repairs, out-of-control periods, or required quality assurance or control activities for purposes of calculating data averages. A monitoring... assurance or control activities (including, as applicable, calibration checks and required zero and span...

40 CFR 63.5355 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2010 CFR

2010-07-01

... periods in assessing the compliance ratio, and, if an emission control device is used, in assessing the...) For emission control devices, except for monitor malfunctions, associated repairs, and required quality assurance or control activities (including, as applicable, calibration checks and required zero...

21 CFR 107.50 - Terms and conditions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Center for Food Safety and Applied Nutrition concludes that additional or modified quality control... also typically represented and labeled for use to provide dietary management for diseases or conditions... regulations promulgated under section 412(a)(2) of the act, the quality control procedure requirements of part...

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…

THE IMPORTANCE OF A SUCCESSFUL QUALITY ASSURANCE (QA) PROGRAM FROM A RESEARCH MANAGER'S PERSPECTIVE

EPA Science Inventory

The paper discusses the Air Pollution Prevention and Control Division's Quality Assurance (QA) program and the approaches used to meet QA requirements in the Division. The presentation is a technical manager's perspective of the Division's requirements for and approach to QA in i...

40 CFR 63.6135 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Combustion Turbines Continuous Compliance Requirements § 63.6135 How do I monitor and collect data to... quality assurance or quality control activities (including, as applicable, calibration checks and required... times the stationary combustion turbine is operating. (b) Do not use data recorded during monitor...

40 CFR 63.6135 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Combustion Turbines Continuous Compliance Requirements § 63.6135 How do I monitor and collect data to... quality assurance or quality control activities (including, as applicable, calibration checks and required... times the stationary combustion turbine is operating. (b) Do not use data recorded during monitor...

40 CFR 63.6135 - How do I monitor and collect data to demonstrate continuous compliance?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Combustion Turbines Continuous Compliance Requirements § 63.6135 How do I monitor and collect data to... quality assurance or quality control activities (including, as applicable, calibration checks and required... times the stationary combustion turbine is operating. (b) Do not use data recorded during monitor...

Environmental Law

DTIC Science & Technology

2002-06-01

Interior’s Bureau of Land Management (BLM). Flue - Gas Desulfurization (FGD). Post-combustion sulfur dioxide control technology in which a scrubber...4. Individual Control Strategies for Toxic Pollutants. a. The CWA requires states to identify “impaired” water bodies within their...water quality standards. Thereafter, states must develop “individual control strategies ” (ICSs) to regulate such pollutants and achieve water quality

Quality assessment concept of the World Data Center for Climate and its application to CMIP5 data

NASA Astrophysics Data System (ADS)

Stockhause, M.; Höck, H.; Toussaint, F.; Lautenschlager, M.

2012-08-01

The preservation of data in a high state of quality which is suitable for interdisciplinary use is one of the most pressing and challenging current issues in long-term archiving. For high volume data such as climate model data, the data and data replica are no longer stored centrally but distributed over several local data repositories, e.g. the data of the Climate Model Intercomparison Project Phase 5 (CMIP5). The most important part of the data is to be archived, assigned a DOI, and published according to the World Data Center for Climate's (WDCC) application of the DataCite regulations. The integrated part of WDCC's data publication process, the data quality assessment, was adapted to the requirements of a federated data infrastructure. A concept of a distributed and federated quality assessment procedure was developed, in which the workload and responsibility for quality control is shared between the three primary CMIP5 data centers: Program for Climate Model Diagnosis and Intercomparison (PCMDI), British Atmospheric Data Centre (BADC), and WDCC. This distributed quality control concept, its pilot implementation for CMIP5, and first experiences are presented. The distributed quality control approach is capable of identifying data inconsistencies and to make quality results immediately available for data creators, data users and data infrastructure managers. Continuous publication of new data versions and slow data replication prevents the quality control from check completion. This together with ongoing developments of the data and metadata infrastructure requires adaptations in code and concept of the distributed quality control approach.

Quality Control Review of Office of the State Auditor Mississippi State University Fiscal Year Ended June 30, 1996

DTIC Science & Technology

1998-04-10

The objective of a quality control review is to ensure that the audit was conducted in accordance with applicable standards and meets the auditing requirements of the 0MB Circular A-i 33. As a Federal finding agency for the University, we conducted a quality control review of the audit working papers. We focused our review on the following qualitative aspects of the audit : due professional

KPMG Peat Marwick LLP GreatLakes Composites Consortium, Inc. Fiscal Year Ended December 31, 1995

DTIC Science & Technology

1997-06-25

The objective of a quality control review is to assure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-133. As the cognizant agency for the Institute, we conducted a quality control review of the audit working papers. We...focused our review on the qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control, internal

48 CFR 1646.201 - Contract Quality Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

40 CFR 52.1280 - Significant deterioration of air quality.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality. 52.1280 Section 52.1280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Significant deterioration of air quality. (a) All applications and other information required pursuant to § 52... Address: Mississippi Department of Environmental Quality, Office of Pollution Control, Air Division, P.O...

40 CFR 52.1280 - Significant deterioration of air quality.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality. 52.1280 Section 52.1280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Significant deterioration of air quality. (a) All applications and other information required pursuant to § 52... Address: Mississippi Department of Environmental Quality, Office of Pollution Control, Air Division, P.O...

40 CFR 52.1280 - Significant deterioration of air quality.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality. 52.1280 Section 52.1280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Significant deterioration of air quality. (a) All applications and other information required pursuant to § 52... Address: Mississippi Department of Environmental Quality, Office of Pollution Control, Air Division, P.O...

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

[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.

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.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Orion Handling Qualities During ISS Proximity Operations and Docking

NASA Technical Reports Server (NTRS)

Stephens, John-Paul; Vos, Gordon A.; Bilimoria, Karl D.; Mueller, Eric R.; Brazzel, Jack; Spehar, Pete

2011-01-01

NASA's Orion spacecraft is designed to autonomously rendezvous and dock with many vehicles including the International Space Station. However, the crew is able to assume manual control of the vehicle s attitude and flight path. In these instances, Orion must meet handling qualities requirements established by NASA. Two handling qualities assessments were conducted at the Johnson Space Center to evaluate preliminary designs of the vehicle using a six degree of freedom, high-fidelity guidance, navigation, and control simulation. The first assessed Orion s handling qualities during the last 20 ft before docking, and included both steady and oscillatory motions of the docking target. The second focused on manual acquisition of the docking axis during the proximity operations phase and subsequent station-keeping. Cooper-Harper handling qualities ratings, workload ratings and comments were provided by 10 evaluation pilots for the docking study and 5 evaluation pilots for the proximity operations study. For the docking task, both cases received 90% Level 1 (satisfactory) handling qualities ratings, exceeding NASA s requirement. All ratings for the ProxOps task were Level 1. These evaluations indicate that Orion is on course to meet NASA's handling quality requirements for ProxOps and docking.

[Highly quality-controlled radiation therapy].

PubMed

Shirato, Hiroki

2005-04-01

Advanced radiation therapy for intracranial disease has focused on set-up accuracy for the past 15 years. However, quality control in the prescribed dose is actually as important as the tumor set-up in radiation therapy. Because of the complexity of the three-dimensional radiation treatment planning system in recent years, the highly quality-controlled prescription of the dose has now been reappraised as the mainstream to improve the treatment outcome of radiation therapy for intracranial disease. The Japanese Committee for Quality Control of Radiation Therapy has developed fundamental requirements such as a QC committee in each hospital, a medical physicist, dosimetrists (QC members), and an external audit.

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Characterizing SWCNT Dispersion in Polymer Composites

NASA Technical Reports Server (NTRS)

Lillehei, Peter T.; Kim, Jae-Woo; Gibbons, Luke; Park, Cheol

2007-01-01

The new wave of single wall carbon nanotube (SWCNT) infused composites will yield structurally sound multifunctional nanomaterials. The SWCNT network requires thorough dispersion within the polymer matrix in order to maximize the benefits of the nanomaterial. However, before any nanomaterials can be used in aerospace applications a means of quality assurance and quality control must be certified. Quality control certification requires a means of quantification, however, the measurement protocol mandates a method of seeing the dispersion first. We describe here the new tools that we have developed and implemented to first be able to see carbon nanotubes in polymers and second to measure or quantify the dispersion of the nanotubes.

Cost analysis of impacts of climate change on regional air quality.

PubMed

Liao, Kuo-Jen; Tagaris, Efthimios; Russell, Armistead G; Amar, Praveen; He, Shan; Manomaiphiboon, Kasemsan; Woo, Jung-Hun

2010-02-01

Climate change has been predicted to adversely impact regional air quality with resulting health effects. Here a regional air quality model and a technology analysis tool are used to assess the additional emission reductions required and associated costs to offset impacts of climate change on air quality. Analysis is done for six regions and five major cities in the continental United States. Future climate is taken from a global climate model simulation for 2049-2051 using the Intergovernmental Panel on Climate Change (IPCC) A1B emission scenario, and emission inventories are the same as current ones to assess impacts of climate change alone on air quality and control expenses. On the basis of the IPCC A1B emission scenario and current control technologies, least-cost sets of emission reductions for simultaneously offsetting impacts of climate change on regionally averaged 4th highest daily maximum 8-hr average ozone and yearly averaged PM2.5 (particulate matter [PM] with an aerodynamic diameter less than 2.5 microm) for the six regions examined are predicted to range from $36 million (1999$) yr(-1) in the Southeast to $5.5 billion yr(-1) in the Northeast. However, control costs to offset climate-related pollutant increases in urban areas can be greater than the regional costs because of the locally exacerbated ozone levels. An annual cost of $4.1 billion is required for offsetting climate-induced air quality impairment in 2049-2051 in the five cities alone. Overall, an annual cost of $9.3 billion is estimated for offsetting climate change impacts on air quality for the six regions and five cities examined. Much of the additional expense is to reduce increased levels of ozone. Additional control costs for offsetting the impacts everywhere in the United States could be larger than the estimates in this study. This study shows that additional emission controls and associated costs for offsetting climate impacts could significantly increase currently estimated control requirements and should be considered in developing control strategies for achieving air quality targets in the future.

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.

The Status of the Quality Control in Acupuncture-Neuroimaging Studies

PubMed Central

Qiu, Ke; Jing, Miaomiao; Liu, Xiaoyan; Gao, Feifei; Liang, Fanrong; Zeng, Fang

2016-01-01

Using neuroimaging techniques to explore the central mechanism of acupuncture gains increasing attention, but the quality control of acupuncture-neuroimaging study remains to be improved. We searched the PubMed Database during 1995 to 2014. The original English articles with neuroimaging scan performed on human beings were included. The data involved quality control including the author, sample size, characteristics of the participant, neuroimaging technology, and acupuncture intervention were extracted and analyzed. The rigorous inclusion and exclusion criteria are important guaranty for the participants' homogeneity. The standard operation process of acupuncture and the stricter requirement for acupuncturist play significant role in quality control. More attention should be paid to the quality control in future studies to improve the reproducibility and reliability of the acupuncture-neuroimaging studies. PMID:27242911

A pilot's assessment of helicopter handling-quality factors common to both agility and instrument flying tasks

NASA Technical Reports Server (NTRS)

Gerdes, R. M.

1980-01-01

Results from a series of simulation and flight investigations undertaken to evaluate helicopter flying qualities and the effects of control system augmentation for nap-of-the-earth (NOE) agility and instrument flying tasks were analyzed to assess handling-quality factors common to both tasks. Precise attitude control was determined to be a key requirement for successful accomplishment of both tasks. Factors that degraded attitude controllability were improper levels of control sensitivity and damping and rotor-system cross-coupling due to helicopter angular rate and collective pitch input. Application of rate-command, attitude-command, and control-input decouple augmentation schemes enhanced attitude control and significantly improved handling qualities for both tasks. NOE agility and instrument flying handling-quality considerations, pilot rating philosophy, and supplemental flight evaluations are also discussed.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

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

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

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

Lewis, Michael G.

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

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

DOT National Transportation Integrated Search

2015-02-01

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

42 CFR 476.71 - QIO review requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... care) for the palliation and management of terminal illness; (2) Whether the quality of the services... Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS UTILIZATION AND QUALITY CONTROL REVIEW Review Responsibilities...

Producing Quality Water for Industrial Use.

ERIC Educational Resources Information Center

Schaezler, Donald J.

1978-01-01

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

Statistical survey of XB-70 airplane responses and control usage with an illustration of the application to handling qualities criteria

NASA Technical Reports Server (NTRS)

Powers, B. G.

1972-01-01

The magnitude and frequency of occurrence of aircraft responses and control inputs during 27 flights of the XB-70 airplane were measured. Exceedance curves are presented for the airplane responses and control usage. A technique is presented which makes use of these exceedance curves to establish or verify handling qualities criteria. This technique can provide a means of incorporating current operational experience in handling qualities requirements for future aircraft.

Linking fish tolerance to water quality criteria for the assessment of environmental flows: A practical method for streamflow regulation and pollution control.

PubMed

Zhao, Changsen; Yang, Shengtian; Liu, Junguo; Liu, Changming; Hao, Fanghua; Wang, Zhonggen; Zhang, Huitong; Song, Jinxi; Mitrovic, Simon M; Lim, Richard P

2018-05-15

The survival of aquatic biota in stream ecosystems depends on both water quantity and quality, and is particularly susceptible to degraded water quality in regulated rivers. Maintenance of environmental flows (e-flows) for aquatic biota with optimum water quantity and quality is essential for sustainable ecosystem services, especially in developing regions with insufficient stream monitoring of hydrology, water quality and aquatic biota. Few e-flow methods are available that closely link aquatic biota tolerances to pollutant concentrations in a simple and practical manner. In this paper a new method was proposed to assess e-flows that aimed to satisfy the requirements of aquatic biota for both the quantity and quality of the streamflow by linking fish tolerances to water quality criteria, or the allowable concentration of pollutants. For better operation of water projects and control of pollutants discharged into streams, this paper presented two coefficients for streamflow adjustment and pollutant control. Assessment of e-flows in the Wei River, the largest tributary of the Yellow River, shows that streamflow in dry seasons failed to meet e-flow requirements. Pollutant influx exerted a large pressure on the aquatic ecosystem, with pollutant concentrations much higher than that of the fish tolerance thresholds. We found that both flow velocity and water temperature exerted great influences on the pollutant degradation rate. Flow velocity had a much greater influence on pollutant degradation than did the standard deviation of flow velocity. This study provides new methods to closely link the tolerance of aquatic biota to water quality criteria for e-flow assessment. The recommended coefficients for streamflow adjustment and pollutant control, to dynamically regulate streamflow and control pollutant discharge, are helpful for river management and ecosystems rehabilitation. The relatively low data requirement also makes the method easy to use efficiently in developing regions, and thus this study has significant implications for managing flows in polluted and regulated rivers worldwide. Copyright © 2018. Published by Elsevier Ltd.

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

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

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

USDA-ARS?s Scientific Manuscript database

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

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... will be produced by a Project Delivery Team. The quality control plan shall be included in the Project Management Plan and shall describe the procedures to be used to ensure compliance with technical and policy requirements during implementation. (b) During development of the Project Management Plan for each project, the...

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

Sailer, S.J.

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

Double shell tanks (DST) chemistry control data quality objectives

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

BANNING, D.L.

2001-10-09

One of the main functions of the River Protection Project is to store the Hanford Site tank waste until the Waste Treatment Plant (WTP) is ready to receive and process the waste. Waste from the older single-shell tanks is being transferred to the newer double-shell tanks (DSTs). Therefore, the integrity of the DSTs must be maintained until the waste from all tanks has been retrieved and transferred to the WTP. To help maintain the integrity of the DSTs over the life of the project, specific chemistry limits have been established to control corrosion of the DSTs. These waste chemistry limitsmore » are presented in the Technical Safety Requirements (TSR) document HNF-SD-WM-TSR-006, Sec. 5 . IS, Rev 2B (CHG 200 I). In order to control the chemistry in the DSTs, the Chemistry Control Program will require analyses of the tank waste. This document describes the Data Quality Objective (DUO) process undertaken to ensure appropriate data will be collected to control the waste chemistry in the DSTs. The DQO process was implemented in accordance with Data Quality Objectives for Sampling and Analyses, HNF-IP-0842, Rev. Ib, Vol. IV, Section 4.16, (Banning 2001) and the U.S. Environmental Protection Agency EPA QA/G4, Guidance for the Data Quality Objectives Process (EPA 1994), with some modifications to accommodate project or tank specific requirements and constraints.« less

Flight Control Development for the ARH-70 Armed Reconnaissance Helicopter Program

NASA Technical Reports Server (NTRS)

Christensen, Kevin T.; Campbell, Kip G.; Griffith, Carl D.; Ivler, Christina M.; Tischler, Mark B.; Harding, Jeffrey W.

2008-01-01

In July 2005, Bell Helicopter won the U.S. Army's Armed Reconnaissance Helicopter competition to produce a replacement for the OH-58 Kiowa Warrior capable of performing the armed reconnaissance mission. To meet the U.S. Army requirement that the ARH-70A have Level 1 handling qualities for the scout rotorcraft mission task elements defined by ADS-33E-PRF, Bell equipped the aircraft with their generic automatic flight control system (AFCS). Under the constraints of the tight ARH-70A schedule, the development team used modem parameter identification and control law optimization techniques to optimize the AFCS gains to simultaneously meet multiple handling qualities design criteria. This paper will show how linear modeling, control law optimization, and simulation have been used to produce a Level 1 scout rotorcraft for the U.S. Army, while minimizing the amount of flight testing required for AFCS development and handling qualities evaluation of the ARH-70A.

[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.

Mathematical modeling for resource and energy saving control of extruders in multi-assortment productions of polymeric films

NASA Astrophysics Data System (ADS)

Polosin, A. N.; Chistyakova, T. B.

2018-05-01

In this article, the authors describe mathematical modeling of polymer processing in extruders of various types used in extrusion and calender productions of film materials. The method consists of the synthesis of a static model for calculating throughput, energy consumption of the extruder, extrudate quality indices, as well as a dynamic model for evaluating polymer residence time in the extruder, on which the quality indices depend. Models are adjusted according to the extruder type (single-screw, reciprocating, twin-screw), its screw and head configuration, extruder’s work temperature conditions, and the processed polymer type. Models enable creating extruder screw configurations and determining extruder controlling action values that provide the extrudate of required quality while satisfying extruder throughput and energy consumption requirements. Model adequacy has been verified using polyolefins’ and polyvinylchloride processing data in different extruders. The program complex, based on mathematical models, has been developed in order to control extruders of various types in order to ensure resource and energy saving in multi-assortment productions of polymeric films. Using the program complex in the control system for the extrusion stage of the polymeric film productions enables improving film quality, reducing spoilage, lessening the time required for production line change-over to other throughput and film type assignment.

Analysis of wind-tunnel stability and control tests in terms of flying qualities of full-scale airplanes

NASA Technical Reports Server (NTRS)

Kayten, Gerald G

1945-01-01

The analysis of results of wind-tunnel stability and control tests of powered airplane models in terms of the flying qualities of full-scale airplanes is advocated. In order to indicated the topics upon which comments are considered desirable in the report of a wind-tunnel stability and control investigation and to demonstrate the nature of the suggested analysis, the present NACA flying-qualities requirements are discussed in relation to wind-tunnel tests. General procedures for the estimation of flying qualities from wind-tunnel tests are outlined.

40 CFR 52.683 - Significant deterioration of air quality.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality. 52.683 Section 52.683 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... deterioration of air quality. (a) The State of Idaho Rules for Control of Air Pollution in Idaho, specifically... the Clean Air Act for preventing significant deterioration of air quality. (b) The requirements of...

40 CFR 52.683 - Significant deterioration of air quality.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality. 52.683 Section 52.683 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... deterioration of air quality. (a) The State of Idaho Rules for Control of Air Pollution in Idaho, specifically... the Clean Air Act for preventing significant deterioration of air quality. (b) The requirements of...

40 CFR 52.683 - Significant deterioration of air quality.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality. 52.683 Section 52.683 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... deterioration of air quality. (a) The State of Idaho Rules for Control of Air Pollution in Idaho, specifically... Air Act for preventing significant deterioration of air quality. (b) The requirements of sections 160...

40 CFR 52.683 - Significant deterioration of air quality.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality. 52.683 Section 52.683 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... deterioration of air quality. (a) The State of Idaho Rules for Control of Air Pollution in Idaho, specifically... the Clean Air Act for preventing significant deterioration of air quality. (b) The requirements of...

Joint Optics Structures Experiment (JOSE)

NASA Technical Reports Server (NTRS)

Founds, David

1987-01-01

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

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

PubMed

Barbaroux, Magali; Gerighausen, Susanne; Hackel, Heiko

2014-01-01

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

Polymerase Chain Reaction/Rapid Methods Are Gaining a Foothold in Developing Countries.

PubMed

Ragheb, Suzan Mohammed; Jimenez, Luis

Detection of microbial contamination in pharmaceutical raw materials and finished products is a critical factor to guarantee their safety, stability, and potency. Rapid microbiological methods-such as polymerase chain reaction-have been widely applied to clinical and food quality control analysis. However, polymerase chain reaction applications to pharmaceutical quality control have been rather slow and sporadic. Successful implementation of these methods in pharmaceutical companies in developing countries requires important considerations to provide sensitive and robust assays that will comply with good manufacturing practices. In recent years several publications have encouraged the application of molecular techniques in the microbiological assessment of pharmaceuticals. One of these techniques is polymerase chain reaction (PCR). The successful application of PCR in the pharmaceutical industry in developing countries is governed by considerable factors and requirements. These factors include the setting up of a PCR laboratory and the choice of appropriate equipment and reagents. In addition, the presence of well-trained analysts and establishment of quality control and quality assurance programs are important requirements. The pharmaceutical firms should take into account these factors to allow better chances for regulatory acceptance and wide application of this technique. © PDA, Inc. 2014.

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

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

NASA Astrophysics Data System (ADS)

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

2016-07-01

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

40 CFR Appendix B to Part 425 - Modified Monier-Williams Method

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Modified Monier-Williams Method B... Appendix B to Part 425—Modified Monier-Williams Method Outline of Method Hydrogen sulfide is liberated from.... Quality Control 1. Each laboratory that uses this method is required to operate a formal quality control...

40 CFR Appendix B to Part 425 - Modified Monier-Williams Method

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Modified Monier-Williams Method B... Part 425—Modified Monier-Williams Method Outline of Method Hydrogen sulfide is liberated from an.... Quality Control 1. Each laboratory that uses this method is required to operate a formal quality control...

40 CFR Appendix B to Part 425 - Modified Monier-Williams Method

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Modified Monier-Williams Method B... Part 425—Modified Monier-Williams Method Outline of Method Hydrogen sulfide is liberated from an.... Quality Control 1. Each laboratory that uses this method is required to operate a formal quality control...

21 CFR 111.140 - Under this subpart F, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... and making a disposition decision and written procedures for approving or rejecting any reprocessing... perform the quality control operation, who conducted the material review and made the disposition decision... System: Requirements for Quality Control § 111.140 Under this subpart F, what records must you make and...

Alternative Strategies for Control of Sulfur Dioxide Emissions

ERIC Educational Resources Information Center

MacDonald, Bryce I.

1975-01-01

Achievement of air quality goals requires careful consideration of alternative control strategies in view of national concerns with energy and the economy. Three strategies which might be used by coal fired steam electric plants to achieve ambient air quality standards for sulfur dioxide have been compared and the analysis presented. (Author/BT)

California State Implementation Plan; Final Approval of Revision; Yolo-Solano Air Quality Management District; Reasonably Available Control Technology Requirements for 1997 8-hour Ozone NAAQS

EPA Pesticide Factsheets

EPA is taking final action to approve a revision to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California SIP concerning YSAQMD regarding RACT)requirements the 1997 8-hour ozone NAAQS and approve negative declarations into SIP.

Quality control in diagnostic immunohistochemistry: integrated on-slide positive controls.

PubMed

Bragoni, A; Gambella, A; Pigozzi, S; Grigolini, M; Fiocca, R; Mastracci, L; Grillo, F

2017-11-01

Standardization in immunohistochemistry is a priority in modern pathology and requires strict quality control. Cost containment has also become fundamental and auditing of all procedures must take into account both these principles. Positive controls must be routinely performed so that their positivity guarantees the appropriateness of the immunohistochemical procedure. The aim of this study is to develop a low cost (utilizing a punch biopsy-PB-tool) procedure to construct positive controls which can be integrated in the patient's tissue slide. Sixteen frequently used control blocks were selected and multiple cylindrical samples were obtained using a 5-mm diameter punch biopsy tool, separately re-embedding them in single blocks. For each diagnostic immunoreaction requiring a positive control, an integrated PB-control section (cut from the appropriate PB-control block) was added to the top right corner of the diagnostic slide before immunostaining. This integrated control technique permitted a saving of 4.75% in total direct lab costs and proved to be technically feasible and reliable. Our proposal is easy to perform and within the reach of all pathology labs, requires easily available tools, its application costs is less than using external paired controls and ensures that a specific control for each slide is always available.

Helicopter roll control effectiveness criteria program summary

NASA Technical Reports Server (NTRS)

Heffley, Robert K.; Bourne, Simon M.; Mnich, Marc A.

1988-01-01

A study of helicopter roll control effectiveness is summarized for the purpose of defining military helicopter handling qualities requirements. The study is based on an analysis of pilot-in-the-loop task performance of several basic maneuvers. This is extended by a series of piloted simulations using the NASA Ames Vertical Motion Simulator and selected flight data. The main results cover roll control power and short-term response characteristics. In general the handling qualities requirements recommended are set in conjunction with desired levels of flight task and maneuver response which can be directly observed in actual flight. An important aspect of this, however, is that vehicle handling qualities need to be set with regard to some quantitative aspect of mission performance. Specific examples of how this can be accomplished include a lateral unmask/remask maneuver in the presence of a threat and an air tracking maneuver which recognizes the kill probability enhancement connected with decreasing the range to the target. Conclusions and recommendations address not only the handling qualities recommendations, but also the general use of flight simulators and the dependence of mission performance on handling qualities.

40 CFR 52.683 - Significant deterioration of air quality.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality. 52.683 Section 52.683 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... deterioration of air quality. (a) The State of Idaho Rules for Control of Air Pollution in Idaho, specifically... quality. (b) The requirements of sections 160 through 165 of the Clean Air Act are not met for Indian...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

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

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)

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

NASA Technical Reports Server (NTRS)

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

1973-01-01

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

Design, analysis, and control of a large transport aircraft utilizing selective engine thrust as a backup system for the primary flight control. Ph.D. Thesis

NASA Technical Reports Server (NTRS)

Gerren, Donna S.

1995-01-01

A study has been conducted to determine the capability to control a very large transport airplane with engine thrust. This study consisted of the design of an 800-passenger airplane with a range of 5000 nautical miles design and evaluation of a flight control system, and design and piloted simulation evaluation of a thrust-only backup flight control system. Location of the four wing-mounted engines was varied to optimize the propulsive control capability, and the time constant of the engine response was studied. The goal was to provide level 1 flying qualities. The engine location and engine time constant did not have a large effect on the control capability. The airplane design did meet level 1 flying qualities based on frequencies, damping ratios, and time constants in the longitudinal and lateral-directional modes. Project pilots consistently rated the flying qualities as either level 1 or level 2 based on Cooper-Harper ratings. However, because of the limited control forces and moments, the airplane design fell short of meeting the time required to achieve a 30 deg bank and the time required to respond a control input.

Microbiological water methods: quality control measures for Federal Clean Water Act and Safe Drinking Water Act regulatory compliance.

PubMed

Root, Patsy; Hunt, Margo; Fjeld, Karla; Kundrat, Laurie

2014-01-01

Quality assurance (QA) and quality control (QC) data are required in order to have confidence in the results from analytical tests and the equipment used to produce those results. Some AOAC water methods include specific QA/QC procedures, frequencies, and acceptance criteria, but these are considered to be the minimum controls needed to perform a microbiological method successfully. Some regulatory programs, such as those at Code of Federal Regulations (CFR), Title 40, Part 136.7 for chemistry methods, require additional QA/QC measures beyond those listed in the method, which can also apply to microbiological methods. Essential QA/QC measures include sterility checks, reagent specificity and sensitivity checks, assessment of each analyst's capabilities, analysis of blind check samples, and evaluation of the presence of laboratory contamination and instrument calibration and checks. The details of these procedures, their performance frequency, and expected results are set out in this report as they apply to microbiological methods. The specific regulatory requirements of CFR Title 40 Part 136.7 for the Clean Water Act, the laboratory certification requirements of CFR Title 40 Part 141 for the Safe Drinking Water Act, and the International Organization for Standardization 17025 accreditation requirements under The NELAC Institute are also discussed.

Lessions learned in WISE image quality

NASA Astrophysics Data System (ADS)

Kendall, Martha; Duval, Valerie G.; Larsen, Mark F.; Heinrichsen, Ingolf H.; Esplin, Roy W.; Shannon, Mark; Wright, Edward L.

2010-08-01

The Wide-Field Infrared Survey Explorer (WISE) mission launched in December of 2009 is a true success story. The mission is performing beyond expectations on-orbit and maintained cost and schedule throughout. How does such a thing happen? A team constantly focused on mission success is a key factor. Mission success is more than a program meeting its ultimate science goals; it is also meeting schedule and cost goals to avoid cancellation. The WISE program can attribute some of its success in achieving the image quality needed to meet science goals to lessons learned along the way. A requirement was missed in early decomposition, the absence of which would have adversely affected end-to-end system image quality. Fortunately, the ability of the cross-organizational team to focus on fixing the problem without pointing fingers or waiting for paperwork was crucial in achieving a timely solution. Asking layman questions early in the program could have revealed requirement flowdown misunderstandings between spacecraft control stability and image processing needs. Such is the lesson learned with the WISE spacecraft Attitude Determination & Control Subsystem (ADCS) jitter control and the image data reductions needs. Spacecraft motion can affect image quality in numerous ways. Something as seemingly benign as different terminology being used by teammates in separate groups working on data reduction, spacecraft ADCS, the instrument, mission operations, and the science proved to be a risk to system image quality. While the spacecraft was meeting the allocated jitter requirement , the drift rate variation need was not being met. This missing need was noticed about a year before launch and with a dedicated team effort, an adjustment was made to the spacecraft ADCS control. WISE is meeting all image quality requirements on-orbit thanks to a diligent team noticing something was missing before it was too late and applying their best effort to find a solution.

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

10 CFR 74.59 - Quality assurance and accounting requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... analyses and evaluations of the design, installation, preoperational tests, calibration, and operation of... performed at a pre-determined frequency, indicate a need for recalibration. Calibrations and tests must be... necessary for performance of the material control tests required by § 74.53(b). (e) Measurement control. The...

10 CFR 74.59 - Quality assurance and accounting requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... analyses and evaluations of the design, installation, preoperational tests, calibration, and operation of... performed at a pre-determined frequency, indicate a need for recalibration. Calibrations and tests must be... necessary for performance of the material control tests required by § 74.53(b). (e) Measurement control. The...

GEOSPATIAL QA

EPA Science Inventory

Geospatial Science is increasingly becoming an important tool in making Agency decisions. Quality Control and Quality Assurance are required to be integrated during the planning, implementation and assessment of geospatial databases, processes and products. In order to ensure Age...

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

NASA Astrophysics Data System (ADS)

Schmitt, R.; Pavim, A.

2009-06-01

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

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

PubMed

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

2013-06-01

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

Quality Assurance Project Plan - Modeling the Impact of Hydraulic Fracturing on Water Resources Based on Water Acquisition Scenarios

EPA Pesticide Factsheets

This planning document describes the quality assurance/quality control activities and technical requirements that will be used during the research study. The goal of this project is to evaluate the potential impacts of large volume water withdrawals.

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

PubMed

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

2017-09-01

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

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

PubMed

Kroes, Burt H

2014-12-02

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

Kodak Skills Enhancement Program Curriculum: Math for Manufacturing and Quality Control. Report No. AEP-93-01.

ERIC Educational Resources Information Center

Beaudin, Bart P.; And Others

This teacher's guide is intended for use in helping Kodak Corporation employees develop the basic mathematics skills required to perform the manufacturing and quality control tasks expected of them. The following topics are covered in the first five modules: the four basic functions (adding, subtracting, multiplying, and dividing), calculations…

The Hazardous-Drums Project: A Multiweek Laboratory Exercise for General Chemistry Involving Environmental, Quality Control, and Cost Evaluation

ERIC Educational Resources Information Center

Hayes, David; Widanski, Bozena

2013-01-01

A laboratory experiment is described that introduces students to "real-world" hazardous waste management issues chemists face. The students are required to define an analytical problem, choose a laboratory analysis method, investigate cost factors, consider quality-control issues, interpret the meaning of results, and provide management…

Automatic Rotational Sky Quality Meter (R-SQM) Design and Software for Astronomical Observatories

NASA Astrophysics Data System (ADS)

Dogan, E.; Ozbaldan, E. E.; Shameoni, Niaei M.; Yesilyaprak, C.

2016-12-01

We have presented the new design of Sky Quality Meter (SQM) device that is an automatic rotational model of sky quality meter (R-SQM) carried out by DAG (Eastern Anatolia Observatory) Technical Team. R-SQM is required for determining the long-term changes of sky quality of an astronomical observatory and consists of four SQM devices mounted on a rotating shaft with different angles for scanning all sky. This system is controlled by a Raspberry Pi control card and a step motor with its driver and a special software.

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.

Design and development of a structural mode control system

NASA Technical Reports Server (NTRS)

1977-01-01

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

Welding and joining techniques.

PubMed

Chipperfield, F A; Dunkerton, S B

2001-05-01

There is a welding solution for most applications. As products must meet more stringent requirements or require more flexible processes to aid design or reduce cost, further improvements or totally new processes are likely to be developed. Quality control aspects are also becoming more important to meet regulation, and monitoring and control of welding processes and the standardised testing of joints will meet some if not all of these requirements.

A Total Quality-Control Plan with Right-Sized Statistical Quality-Control.

PubMed

Westgard, James O

2017-03-01

A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right-sized statistical QC procedure to detect medically important errors. Westgard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements. Copyright © 2016 Elsevier Inc. All rights reserved.

CHALLENGES IN SETTING UP QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY FACILITIES IN NIGERIA.

PubMed

Inyang, S O; Egbe, N O; Ekpo, E

2015-01-01

The Nigerian Nuclear Regulatory Authority (NNRA) was established to regulate and control the use of radioactive and radiation emitting sources in Nigeria. Quality control (QC) on diagnostic radiology equipment form part of the fundamental requirements for the authorization of diagnostic radiology facilities in the Country. Some quality control tests (output, exposure linearity and reproducibility) were measured on the x-ray machines in the facilities that took part in the study. Questionnaire was developed to evaluate the frequencies at which QC tests were conducted in the facilities and the challenges in setting up QC. Results show great variation in the values of the QC parameters measured. Inadequate cooperation by facilities management, lack of QC equipment and insufficient staff form the major challenges in setting up QC in the facilities under study. The responses on the frequencies at which QC tests should be conducted did not correspond to the recommended standards; indicating that personnel were not familiar with QC implementation and may require further training on QC.

STOVL Control Integration Program

NASA Technical Reports Server (NTRS)

Weiss, C.; Mcdowell, P.; Watts, S.

1994-01-01

An integrated flight/propulsion control for an advanced vector thrust supersonic STOVL aircraft, was developed by Pratt & Whitney and McDonnell Douglas Aerospace East. The IFPC design was based upon the partitioning of the global requirements into flight control and propulsion control requirements. To validate the design, aircraft and engine models were also developed for use on a NASA Ames piloted simulator. Different flight control implementations, evaluated for their handling qualities, are documented in the report along with the propulsion control, engine model, and aircraft model.

42 CFR 423.150 - Scope.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

[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.

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

Engels, J.

The Environmental Restoration (ER) Program was established for the investigation and remediation of inactive US Department of Energy (DOE) sites and facilities that have been declared surplus in terms of their previous uses. The purpose of this document is to Specify ER requirements for quality control (QC) of analytical data. Activities throughout all phases of the investigation may affect the quality of the final data product, thus are subject to control specifications. Laboratory control is emphasized in this document, and field concerns will be addressed in a companion document Energy Systems, in its role of technical coordinator and at themore » request of DOE-OR, extends the application of these requirements to all participants in ER activities. Because every instance and concern may not be addressed in this document, participants are encouraged to discuss any questions with the ER Quality Assurance (QA) Office, the Analytical Environmental Support Group (AESG), or the Analytical Project Office (APO).« less

Analysis of the Parameters Required for Performance Monitoring and Assessment of Military Communications Systems by Military Technical Controller

DTIC Science & Technology

1975-12-01

139 APPENDIX A* BASIC CONCEPT OF MILITARY TECHNICAL CONTROL.142 6 APIENDIX Es TEST EQUIPMENI REQUIRED FOR lEASURF.4ENr OF 1AF’AMETE RS...Control ( SATEC ) Automatic Facilities heport Army Automated Quality Monitoring Reporting System (AQMPS) Army Autcmated Technical Control-Semi (ATC-Semi...technical control then beco.. es equipment status monitoring. All the major equipment in a system wculd have internal sensors with properly selected parameters

40 CFR 52.275 - Particulate matter control.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

A robot control formalism based on an information quality concept

NASA Technical Reports Server (NTRS)

Ekman, A.; Torne, A.; Stromberg, D.

1994-01-01

A relevance measure based on Jaynes maximum entropy principle is introduced. Information quality is the conjunction of accuracy and relevance. The formalism based on information quality is developed for one-agent applications. The robot requires a well defined working environment where properties of each object must be accurately specified.

UrQt: an efficient software for the Unsupervised Quality trimming of NGS data.

PubMed

Modolo, Laurent; Lerat, Emmanuelle

2015-04-29

Quality control is a necessary step of any Next Generation Sequencing analysis. Although customary, this step still requires manual interventions to empirically choose tuning parameters according to various quality statistics. Moreover, current quality control procedures that provide a "good quality" data set, are not optimal and discard many informative nucleotides. To address these drawbacks, we present a new quality control method, implemented in UrQt software, for Unsupervised Quality trimming of Next Generation Sequencing reads. Our trimming procedure relies on a well-defined probabilistic framework to detect the best segmentation between two segments of unreliable nucleotides, framing a segment of informative nucleotides. Our software only requires one user-friendly parameter to define the minimal quality threshold (phred score) to consider a nucleotide to be informative, which is independent of both the experiment and the quality of the data. This procedure is implemented in C++ in an efficient and parallelized software with a low memory footprint. We tested the performances of UrQt compared to the best-known trimming programs, on seven RNA and DNA sequencing experiments and demonstrated its optimality in the resulting tradeoff between the number of trimmed nucleotides and the quality objective. By finding the best segmentation to delimit a segment of good quality nucleotides, UrQt greatly increases the number of reads and of nucleotides that can be retained for a given quality objective. UrQt source files, binary executables for different operating systems and documentation are freely available (under the GPLv3) at the following address: https://lbbe.univ-lyon1.fr/-UrQt-.html .

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.

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

[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.

Oromucosal film preparations: classification and characterization methods.

PubMed

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

2013-09-01

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

49 CFR 40.235 - What are the requirements for proper use and care of ASDs?

Code of Federal Regulations, 2014 CFR

2014-10-01

... ASD on the CPL. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g... the specified quality control checks or that has passed its expiration date. (e) As an employer, with...

49 CFR 40.235 - What are the requirements for proper use and care of ASDs?

Code of Federal Regulations, 2012 CFR

2012-10-01

... ASD on the CPL. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g... the specified quality control checks or that has passed its expiration date. (e) As an employer, with...

49 CFR 40.235 - What are the requirements for proper use and care of ASDs?

Code of Federal Regulations, 2011 CFR

2011-10-01

... ASD on the CPL. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g... the specified quality control checks or that has passed its expiration date. (e) As an employer, with...

49 CFR 40.235 - What are the requirements for proper use and care of ASDs?

Code of Federal Regulations, 2010 CFR

2010-10-01

... ASD on the CPL. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g... the specified quality control checks or that has passed its expiration date. (e) As an employer, with...

49 CFR 40.235 - What are the requirements for proper use and care of ASDs?

Code of Federal Regulations, 2013 CFR

2013-10-01

... ASD on the CPL. Your QAP must specify the methods used for quality control checks, temperatures at which the ASD must be stored and used, the shelf life of the device, and environmental conditions (e.g... the specified quality control checks or that has passed its expiration date. (e) As an employer, with...

Quality of mass-reared codling moth (Lepidoptera: Tortricidae) after long distance transportation 1. Logistics of shipping procedures and quality parameters as measured in the laboratory.

USDA-ARS?s Scientific Manuscript database

The sterile insect technique is a proven effective control tactic against lepidopteran pests when applied in an area-wide integrated pest management programme. The construction of insect mass-rearing facilities requires considerable investment and moth control strategies that include the use of ster...

Organic weed conrol and cover crop residue integration impacts on weed control, quality, and yield and economics in conservation tillage tomato - A case study

USDA-ARS?s Scientific Manuscript database

The increased use of conservation tillage in vegetable production requires more information be developed on the role of cover crops in weed control, tomato quality and yield. Three conservation-tillage systems utilizing crimson clover, brassica and cereal rye as winter cover crops were compared to ...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2010 CFR

2010-04-01

... monitoring required under subpart E; (4) Conducting any required material review and making any required disposition decision; (5) Approving or rejecting any reprocessing; (6) Determining whether all in-process... and to determine that the product is consistent with your purchase order. ...

Presentation of flight control design and handling quality commonality by separate surface stability augmentation for the family of commuter airplanes

NASA Technical Reports Server (NTRS)

Hensley, Douglas; Creighton, Thomas; Haddad, Raphael; Hendrich, Louis; Morgan, Louise; Russell, Mark; Swift, Gerald

1987-01-01

The methodology and results for a flight control design and implementation for common handling qualities by Separate Surface Stability Augmentation (SSSA) for the family of commuter airplanes are contained. The open and closed loop dynamics and the design results of augmenting for common handling qualities are presented. The physical and technology requirements are presented for implementing the SSSA system. The conclusion of this report and recommendations for changes or improvement are discussed.

Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels.

PubMed

Zupke, Craig; Brady, Lowell J; Slade, Peter G; Clark, Philip; Caspary, R Guy; Livingston, Brittney; Taylor, Lisa; Bigham, Kyle; Morris, Arvia E; Bailey, Robert W

2015-01-01

Pressures for cost-effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

PubMed

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

Handling Qualities of Model Reference Adaptive Controllers with Varying Complexity for Pitch-Roll Coupled Failures

NASA Technical Reports Server (NTRS)

Schaefer, Jacob; Hanson, Curt; Johnson, Marcus A.; Nguyen, Nhan

2011-01-01

Three model reference adaptive controllers (MRAC) with varying levels of complexity were evaluated on a high performance jet aircraft and compared along with a baseline nonlinear dynamic inversion controller. The handling qualities and performance of the controllers were examined during failure conditions that induce coupling between the pitch and roll axes. Results from flight tests showed with a roll to pitch input coupling failure, the handling qualities went from Level 2 with the baseline controller to Level 1 with the most complex MRAC tested. A failure scenario with the left stabilator frozen also showed improvement with the MRAC. Improvement in performance and handling qualities was generally seen as complexity was incrementally added; however, added complexity usually corresponds to increased verification and validation effort required for certification. The tradeoff between complexity and performance is thus important to a controls system designer when implementing an adaptive controller on an aircraft. This paper investigates this relation through flight testing of several controllers of vary complexity.

Reducing the impact of environmental noise on quality of life requires an effective national noise policy

DOT National Transportation Integrated Search

2003-06-22

The focus here is on the impact of environmental noise on the quality of life. After : reviewing the terms of The Noise Control Act of 1972 (NCA 72) related to quality of life, : the authors explore the following issues: (1) the desire for an accepta...

Water Quality in the Production of Containerized Longleaf Pine Seedlings

Treesearch

David J. Moorhead; John M. Ruter

2002-01-01

The consistent production of quality container grown seedlings requires that key production variables be identified and controlled; otherwise, quality and the percentage of marketable plants will be erratic (Garber and Ruter 1993a). Additionally, production times and costs may increase unless production variables are monitored and managed throughout the production...

42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

Code of Federal Regulations, 2010 CFR

2010-10-01

... PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.153 Drug utilization... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE...

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

ERIC Educational Resources Information Center

Kabashkin, Igor; Michnev, Boris; Utchin, Georgy

1998-01-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Training of U.S. Air Traffic Controllers. (IDA Report No. R-206).

ERIC Educational Resources Information Center

Henry, James H.; And Others

The report reviews the evolution of existing national programs for air traffic controller training, estimates the number of persons requiring developmental and supplementary training, examines present controller selection and training programs, investigates performance measurement methods, considers standardization and quality control, discusses…

Environmental Justice analysis in Hydraulic Fracturing Analysis, June 13, 2011

EPA Pesticide Factsheets

This planning document describes the quality assurance/quality control activities and technical requirements that will be used during the research study, using an index-based approach to compare a nationally representative set of well sites fractured.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

Handling Qualities Implications for Crewed Spacecraft Operations

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Jackson, E. Bruce; Arthur, J. J.

2012-01-01

Abstract Handling qualities embody those qualities or characteristics of an aircraft that govern the ease and precision with which a pilot is able to perform the tasks required in support of an aircraft role. These same qualities are as critical, if not more so, in the operation of spacecraft. A research, development, test, and evaluation process was put into effect to identify, understand, and interpret the engineering and human factors principles which govern the pilot-vehicle dynamic system as they pertain to space exploration missions and tasks. Toward this objective, piloted simulations were conducted at the NASA Langley Research Center and Ames Research Center for earth-orbit proximity operations and docking and lunar landing. These works provide broad guidelines for the design of spacecraft to exhibit excellent handling characteristics. In particular, this work demonstrates how handling qualities include much more than just stability and control characteristics of a spacecraft or aircraft. Handling qualities are affected by all aspects of the pilot-vehicle dynamic system, including the motion, visual and aural cues of the vehicle response as the pilot performs the required operation or task. A holistic approach to spacecraft design, including the use of manual control, automatic control, and pilot intervention/supervision is described. The handling qualities implications of design decisions are demonstrated using these pilot-in-the-loop evaluations of docking operations and lunar landings.

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Electrical, Electronic, and Electromechanical (EEE) parts management and control requirements for NASA space flight programs

NASA Technical Reports Server (NTRS)

1989-01-01

This document establishes electrical, electronic, and electromechanical (EEE) parts management and control requirements for contractors providing and maintaining space flight and mission-essential or critical ground support equipment for NASA space flight programs. Although the text is worded 'the contractor shall,' the requirements are also to be used by NASA Headquarters and field installations for developing program/project parts management and control requirements for in-house and contracted efforts. This document places increased emphasis on parts programs to ensure that reliability and quality are considered through adequate consideration of the selection, control, and application of parts. It is the intent of this document to identify disciplines that can be implemented to obtain reliable parts which meet mission needs. The parts management and control requirements described in this document are to be selectively applied, based on equipment class and mission needs. Individual equipment needs should be evaluated to determine the extent to which each requirement should be implemented on a procurement. Utilization of this document does not preclude the usage of other documents. The entire process of developing and implementing requirements is referred to as 'tailoring' the program for a specific project. Some factors that should be considered in this tailoring process include program phase, equipment category and criticality, equipment complexity, and mission requirements. Parts management and control requirements advocated by this document directly support the concept of 'reliability by design' and are an integral part of system reliability and maintainability. Achieving the required availability and mission success objectives during operation depends on the attention given reliability and maintainability in the design phase. Consequently, it is intended that the requirements described in this document are consistent with those of NASA publications, 'Reliability Program Requirements for Aeronautical and Space System Contractors,' NHB 5300.4(1A-l); 'Maintainability Program Requirements for Space Systems,' NHB 5300.4(1E); and 'Quality Program Provisions for Aeronautical and Space System Contractors,' NHB 5300.4(1B).

Measuring management's perspective of data quality in Pakistan's Tuberculosis control programme: a test-based approach to identify data quality dimensions.

PubMed

Ali, Syed Mustafa; Anjum, Naveed; Kamel Boulos, Maged N; Ishaq, Muhammad; Aamir, Javariya; Haider, Ghulam Rasool

2018-01-16

Data quality is core theme of programme's performance assessment and many organizations do not have any data quality improvement strategy, wherein data quality dimensions and data quality assessment framework are important constituents. As there is limited published research about the data quality specifics that are relevant to the context of Pakistan's Tuberculosis control programme, this study aims at identifying the applicable data quality dimensions by using the 'fitness-for-purpose' perspective. Forty-two respondents pooled a total of 473 years of professional experience, out of which 223 years (47%) were in TB control related programmes. Based on the responses against 11 practical cases, adopted from the routine recording and reporting system of Pakistan's TB control programme (real identities of patient were masked), completeness, accuracy, consistency, vagueness, uniqueness and timeliness are the applicable data quality dimensions relevant to the programme's context, i.e. work settings and field of practice. Based on a 'fitness-for-purpose' approach to data quality, this study used a test-based approach to measure management's perspective and identified data quality dimensions pertinent to the programme and country specific requirements. Implementation of a data quality improvement strategy and achieving enhanced data quality would greatly help organizations in promoting data use for informed decision making.

An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

ERIC Educational Resources Information Center

Allalouf, Avi

2007-01-01

There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

Environmental Assessment for Routine Basewide Military-Sponsored Training Exercises, Edwards Air Force Base, California

DTIC Science & Technology

2007-02-01

control AVAQMD Antelope Valley Air Quality Management District AQMD Air Quality Management Districts BACT Best Available Control Technology BLM Bureau...Aeronautics NAGPRA Native American Graves Protection and Repatriation Act NASA National Aeronautics and Space Administration NBCC nuclear, biological...support of the National Aeronautics and Space Administration ( NASA ) shuttle program is required to be maintained. This includes rescue, medical evaluation

A method for evaluating treatment quality using in vivo EPID dosimetry and statistical process control in radiation therapy.

PubMed

Fuangrod, Todsaporn; Greer, Peter B; Simpson, John; Zwan, Benjamin J; Middleton, Richard H

2017-03-13

Purpose Due to increasing complexity, modern radiotherapy techniques require comprehensive quality assurance (QA) programmes, that to date generally focus on the pre-treatment stage. The purpose of this paper is to provide a method for an individual patient treatment QA evaluation and identification of a "quality gap" for continuous quality improvement. Design/methodology/approach A statistical process control (SPC) was applied to evaluate treatment delivery using in vivo electronic portal imaging device (EPID) dosimetry. A moving range control chart was constructed to monitor the individual patient treatment performance based on a control limit generated from initial data of 90 intensity-modulated radiotherapy (IMRT) and ten volumetric-modulated arc therapy (VMAT) patient deliveries. A process capability index was used to evaluate the continuing treatment quality based on three quality classes: treatment type-specific, treatment linac-specific, and body site-specific. Findings The determined control limits were 62.5 and 70.0 per cent of the χ pass-rate for IMRT and VMAT deliveries, respectively. In total, 14 patients were selected for a pilot study the results of which showed that about 1 per cent of all treatments contained errors relating to unexpected anatomical changes between treatment fractions. Both rectum and pelvis cancer treatments demonstrated process capability indices were less than 1, indicating the potential for quality improvement and hence may benefit from further assessment. Research limitations/implications The study relied on the application of in vivo EPID dosimetry for patients treated at the specific centre. Sampling patients for generating the control limits were limited to 100 patients. Whilst the quantitative results are specific to the clinical techniques and equipment used, the described method is generally applicable to IMRT and VMAT treatment QA. Whilst more work is required to determine the level of clinical significance, the authors have demonstrated the capability of the method for both treatment specific QA and continuing quality improvement. Practical implications The proposed method is a valuable tool for assessing the accuracy of treatment delivery whilst also improving treatment quality and patient safety. Originality/value Assessing in vivo EPID dosimetry with SPC can be used to improve the quality of radiation treatment for cancer patients.

Effects of Meteorological Data Quality on Snowpack Modeling

NASA Astrophysics Data System (ADS)

Havens, S.; Marks, D. G.; Robertson, M.; Hedrick, A. R.; Johnson, M.

2017-12-01

Detailed quality control of meteorological inputs is the most time-intensive component of running the distributed, physically-based iSnobal snow model, and the effect of data quality of the inputs on the model is unknown. The iSnobal model has been run operationally since WY2013, and is currently run in several basins in Idaho and California. The largest amount of user input during modeling is for the quality control of precipitation, temperature, relative humidity, solar radiation, wind speed and wind direction inputs. Precipitation inputs require detailed user input and are crucial to correctly model the snowpack mass. This research applies a range of quality control methods to meteorological input, from raw input with minimal cleaning, to complete user-applied quality control. The meteorological input cleaning generally falls into two categories. The first is global minimum/maximum and missing value correction that could be corrected and/or interpolated with automated processing. The second category is quality control for inputs that are not globally erroneous, yet are still unreasonable and generally indicate malfunctioning measurement equipment, such as temperature or relative humidity that remains constant, or does not correlate with daily trends observed at nearby stations. This research will determine how sensitive model outputs are to different levels of quality control and guide future operational applications.

Training and support to improve ICD coding quality: A controlled before-and-after impact evaluation.

PubMed

Dyers, Robin; Ward, Grant; Du Plooy, Shane; Fourie, Stephanus; Evans, Juliet; Mahomed, Hassan

2017-05-24

The proposed National Health Insurance policy for South Africa (SA) requires hospitals to maintain high-quality International Statistical Classification of Diseases (ICD) codes for patient records. While considerable strides had been made to improve ICD coding coverage by digitising the discharge process in the Western Cape Province, further intervention was required to improve data quality. The aim of this controlled before-and-after study was to evaluate the impact of a clinician training and support initiative to improve ICD coding quality. To compare ICD coding quality between two central hospitals in the Western Cape before and after the implementation of a training and support initiative for clinicians at one of the sites. The difference in differences in data quality between the intervention site and the control site was calculated. Multiple logistic regression was also used to determine the odds of data quality improvement after the intervention and to adjust for potential differences between the groups. The intervention had a positive impact of 38.0% on ICD coding completeness over and above changes that occurred at the control site. Relative to the baseline, patient records at the intervention site had a 6.6 (95% confidence interval 3.5 - 16.2) adjusted odds ratio of having a complete set of ICD codes for an admission episode after the introduction of the training and support package. The findings on impact on ICD coding accuracy were not significant. There is sufficient pragmatic evidence that a training and support package will have a considerable positive impact on ICD coding completeness in the SA setting.

Physical Property Analysis and Report for Sediments at 100-BC-5 Operable Unit, Boreholes C7505, C7506, C7507, and C7665

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

Lindberg, Michael J.

2010-09-28

Between October 14, 2009 and February 22, 2010 sediment samples were received from 100-BC Decision Unit for geochemical studies. This is an analytical data report for sediments received from CHPRC at the 100 BC 5 OU. The analyses for this project were performed at the 325 building located in the 300 Area of the Hanford Site. The analyses were performed according to Pacific Northwest National Laboratory (PNNL) approved procedures and/or nationally recognized test procedures. The data sets include the sample identification numbers, analytical results, estimated quantification limits (EQL), and quality control data. The preparatory and analytical quality control requirements, calibrationmore » requirements, acceptance criteria, and failure actions are defined in the on-line QA plan 'Conducting Analytical Work in Support of Regulatory Programs' (CAW). This QA plan implements the Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD) for PNNL.« less

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

PubMed

Bolann, B J; Asberg, A

2004-01-01

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

Toward a perceptual video-quality metric

NASA Astrophysics Data System (ADS)

Watson, Andrew B.

1998-07-01

The advent of widespread distribution of digital video creates a need for automated methods for evaluating the visual quality of digital video. This is particularly so since most digital video is compressed using lossy methods, which involve the controlled introduction of potentially visible artifacts. Compounding the problem is the bursty nature of digital video, which requires adaptive bit allocation based on visual quality metrics, and the economic need to reduce bit-rate to the lowest level that yields acceptable quality. In previous work, we have developed visual quality metrics for evaluating, controlling,a nd optimizing the quality of compressed still images. These metrics incorporate simplified models of human visual sensitivity to spatial and chromatic visual signals. Here I describe a new video quality metric that is an extension of these still image metrics into the time domain. Like the still image metrics, it is based on the Discrete Cosine Transform. An effort has been made to minimize the amount of memory and computation required by the metric, in order that might be applied in the widest range of applications. To calibrate the basic sensitivity of this metric to spatial and temporal signals we have made measurements of visual thresholds for temporally varying samples of DCT quantization noise.

10 CFR 75.23 - Operating records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Accounting and Control for Facilities § 75.23 Operating records. The operating records required by § 75.21... to control the quality of measurements, and the derived estimates of random and systematic error; (c...

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.

Osteocyte-Intrinsic TGF-β Signaling Regulates Bone Quality through Perilacunar/Canalicular Remodeling

DOE PAGES

Dole, Neha S.; Mazur, Courtney M.; Acevedo, Claire; ...

2017-11-28

Poor bone quality contributes to bone fragility in diabetes, aging, and osteogenesis imperfecta. However, the mechanisms controlling bone quality are not well understood, contributing to the current lack of strategies to diagnose or treat bone quality deficits. Transforming growth factor beta (TGF-β) signaling is a crucial mechanism known to regulate the material quality of bone, but its cellular target in this regulation is unknown. Studies showing that osteocytes directly remodel their perilacunar/canalicular matrix led us to hypothesize that TGF-β controls bone quality through perilacunar/canalicular remodeling (PLR). Using inhibitors and mice with an osteocyte-intrinsic defect in TGF-β signaling (TβRII ocy-/-), wemore » show that TGF-β regulates PLR in a cell-intrinsic manner to control bone quality. Altogether, this study emphasizes that osteocytes are key in executing the biological control of bone quality through PLR, thereby highlighting the fundamental role of osteocyte-mediated PLR in bone homeostasis and fragility. Resistance to fracture requires healthy bone mass and quality. However, the cellular mechanisms regulating bone quality are unclear. Dole et al. show that osteocyte-intrinsic TGF-β signaling maintains bone quality through perilacunar/canalicular remodeling. Thus, osteocytes mediate perilacunar/canalicular remodeling and osteoclast-directed remodeling to cooperatively maintain bone quality and mass and prevent fragility.« less

Osteocyte-Intrinsic TGF-β Signaling Regulates Bone Quality through Perilacunar/Canalicular Remodeling

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

Dole, Neha S.; Mazur, Courtney M.; Acevedo, Claire

Poor bone quality contributes to bone fragility in diabetes, aging, and osteogenesis imperfecta. However, the mechanisms controlling bone quality are not well understood, contributing to the current lack of strategies to diagnose or treat bone quality deficits. Transforming growth factor beta (TGF-β) signaling is a crucial mechanism known to regulate the material quality of bone, but its cellular target in this regulation is unknown. Studies showing that osteocytes directly remodel their perilacunar/canalicular matrix led us to hypothesize that TGF-β controls bone quality through perilacunar/canalicular remodeling (PLR). Using inhibitors and mice with an osteocyte-intrinsic defect in TGF-β signaling (TβRII ocy-/-), wemore » show that TGF-β regulates PLR in a cell-intrinsic manner to control bone quality. Altogether, this study emphasizes that osteocytes are key in executing the biological control of bone quality through PLR, thereby highlighting the fundamental role of osteocyte-mediated PLR in bone homeostasis and fragility. Resistance to fracture requires healthy bone mass and quality. However, the cellular mechanisms regulating bone quality are unclear. Dole et al. show that osteocyte-intrinsic TGF-β signaling maintains bone quality through perilacunar/canalicular remodeling. Thus, osteocytes mediate perilacunar/canalicular remodeling and osteoclast-directed remodeling to cooperatively maintain bone quality and mass and prevent fragility.« less

10 CFR 63.142 - Quality assurance criteria.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Design control. (1) DOE shall establish measures to assure that applicable regulatory requirements and... control design interfaces and for coordination among participating design organizations. These measures... control measures must provide for verifying or checking the adequacy of design, such as by the performance...

10 CFR 63.142 - Quality assurance criteria.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Design control. (1) DOE shall establish measures to assure that applicable regulatory requirements and... control design interfaces and for coordination among participating design organizations. These measures... control measures must provide for verifying or checking the adequacy of design, such as by the performance...

10 CFR 63.142 - Quality assurance criteria.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Design control. (1) DOE shall establish measures to assure that applicable regulatory requirements and... control design interfaces and for coordination among participating design organizations. These measures... control measures must provide for verifying or checking the adequacy of design, such as by the performance...

10 CFR 63.142 - Quality assurance criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Design control. (1) DOE shall establish measures to assure that applicable regulatory requirements and... control design interfaces and for coordination among participating design organizations. These measures... control measures must provide for verifying or checking the adequacy of design, such as by the performance...

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

Longitudinal Handling Qualities of the Tu-144LL Airplane and Comparisons With Other Large, Supersonic Aircraft

NASA Technical Reports Server (NTRS)

Cox, Timothy H.; Marshall, Alisa

2000-01-01

Four flights have been conducted using the Tu-144LL supersonic transport aircraft with the dedicated objective of collecting quantitative data and qualitative pilot comments. These data are compared with the following longitudinal flying qualities criteria: Neal-Smith, short-period damping, time delay, control anticipation parameter, phase delay (omega(sp)*T(theta(2))), pitch bandwidth as a function of time delay, and flight path as a function of pitch bandwidth. Determining the applicability of these criteria and gaining insight into the flying qualities of a large, supersonic aircraft are attempted. Where appropriate, YF-12, XB-70, and SR-71 pilot ratings are compared with the Tu-144LL results to aid in the interpretation of the Tu-144LL data and to gain insight into the application of criteria. The data show that approach and landing requirements appear to be applicable to the precision flightpath control required for up-and-away flight of large, supersonic aircraft. The Neal-Smith, control anticipation parameter, and pitch-bandwidth criteria tend to correlate with the pilot comments better than the phase delay criterion, omega(sp)*T(theta(2)). The data indicate that the detrimental flying qualities implication of decoupled pitch-attitude and flightpath responses occurring for high-speed flight may be mitigated by requiring the pilot to close the loop on flightpath or vertical speed.

Human High Temperature Requirement Serine Protease A1 (HTRA1) Degrades Tau Protein Aggregates*

PubMed Central

Tennstaedt, Annette; Pöpsel, Simon; Truebestein, Linda; Hauske, Patrick; Brockmann, Anke; Schmidt, Nina; Irle, Inga; Sacca, Barbara; Niemeyer, Christof M.; Brandt, Roland; Ksiezak-Reding, Hanna; Tirniceriu, Anca Laura; Egensperger, Rupert; Baldi, Alfonso; Dehmelt, Leif; Kaiser, Markus; Huber, Robert; Clausen, Tim; Ehrmann, Michael

2012-01-01

Protective proteases are key elements of protein quality control pathways that are up-regulated, for example, under various protein folding stresses. These proteases are employed to prevent the accumulation and aggregation of misfolded proteins that can impose severe damage to cells. The high temperature requirement A (HtrA) family of serine proteases has evolved to perform important aspects of ATP-independent protein quality control. So far, however, no HtrA protease is known that degrades protein aggregates. We show here that human HTRA1 degrades aggregated and fibrillar tau, a protein that is critically involved in various neurological disorders. Neuronal cells and patient brains accumulate less tau, neurofibrillary tangles, and neuritic plaques, respectively, when HTRA1 is expressed at elevated levels. Furthermore, HTRA1 mRNA and HTRA1 activity are up-regulated in response to elevated tau concentrations. These data suggest that HTRA1 is performing regulated proteolysis during protein quality control, the implications of which are discussed. PMID:22535953

21 CFR 111.103 - What are the requirements under this subpart F for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... quality control operations, including written procedures for conducting a material review and making a...

40 CFR 52.181 - Significant deterioration of air quality.

Code of Federal Regulations, 2010 CFR

2010-07-01

...”) submitted April 23, 1981 (as adopted by the Arkansas Commission on Pollution Control and Ecology (ACPCE) on... the Arkansas Pollution Control and Ecology Commission on January 22, 1999) (b) The requirements of...

40 CFR 52.181 - Significant deterioration of air quality.

Code of Federal Regulations, 2011 CFR

2011-07-01

...”) submitted April 23, 1981 (as adopted by the Arkansas Commission on Pollution Control and Ecology (ACPCE) on... the Arkansas Pollution Control and Ecology Commission on January 22, 1999) (b) The requirements of...

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

Code of Federal Regulations, 2010 CFR

2010-10-01

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

Treatment of painful diabetic peripheral neuropathy.

PubMed

Rosenberg, Casandra J; Watson, James C

2015-02-01

Painful diabetic peripheral neuropathy impairs quality of life and can be difficult to treat. To discuss current treatment recommendations for painful diabetic peripheral neuropathy. Literature review. Systematic review of the literature discussing treatment of painful diabetic peripheral neuropathy. Existing treatment guidelines were studied and compared. Painful diabetic peripheral neuropathy occurs in about one in six people with diabetes. This condition impairs quality of life and increases healthcare costs. Treatment recommendations exist, but individual patient therapy can require a trial-and-error approach. Many treatment options have adjuvant benefits or side effects which should be considered prior to initiating therapy. Often, a combination of treatment modalities with various mechanisms of action is required for adequate pain control. Adequate medication titration and a reasonable trial period should be allowed. The treatment of painful diabetic peripheral neuropathy can be challenging, but effective management can improve patient's quality of life. Painful diabetic peripheral neuropathy impairs quality of life and can be difficult to treat. Many treatment options have adjuvant benefits or side effects which should be considered prior to initiating therapy. Often, a combination of treatment modalities with various mechanisms of action is required for adequate pain control. © The International Society for Prosthetics and Orthotics 2014.

Quality Assurance Specifications for Planetary Protection Assays

NASA Astrophysics Data System (ADS)

Baker, Amy

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

Validation of gamma irradiator controls for quality and regulatory compliance

NASA Astrophysics Data System (ADS)

Harding, Rorry B.; Pinteric, Francis J. A.

1995-09-01

Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic — Validation of Irradiator Controls — is a significant regulatory compliance and operations issue within the irradiator suppliers' and users' community.

3D laser scanning for quality control and assurance in bridge deck construction.

DOT National Transportation Integrated Search

2014-08-01

The inspection of installations of rebar and other embedded components in bridge deck construction is a tedious : task for eld inspectors, requiring considerable eld time for measurement and verication against code requirement. The verica...

40 CFR 63.10 - Recordkeeping and reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

78 FR 69296 - Approval and Promulgation of Air Quality Implementation Plans; Montana; Revisions to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

....8.1603, 17.8.1604, 17.8.1605, and 17.8.1606, pertaining to the regulation of oil and gas well... Coordination with Montana Air Quality Permit Rules; 17.8.1603, Emission Control Requirements; 17.8.1604...

Flight-Test Validation and Flying Qualities Evaluation of a Rotorcraft UAV Flight Control System

NASA Technical Reports Server (NTRS)

Mettler, Bernard; Tuschler, Mark B.; Kanade, Takeo

2000-01-01

This paper presents a process of design and flight-test validation and flying qualities evaluation of a flight control system for a rotorcraft-based unmanned aerial vehicle (RUAV). The keystone of this process is an accurate flight-dynamic model of the aircraft, derived by using system identification modeling. The model captures the most relevant dynamic features of our unmanned rotorcraft, and explicitly accounts for the presence of a stabilizer bar. Using the identified model we were able to determine the performance margins of our original control system and identify limiting factors. The performance limitations were addressed and the attitude control system was 0ptimize.d for different three performance levels: slow, medium, fast. The optimized control laws will be implemented in our RUAV. We will first determine the validity of our control design approach by flight test validating our optimized controllers. Subsequently, we will fly a series of maneuvers with the three optimized controllers to determine the level of flying qualities that can be attained. The outcome enable us to draw important conclusions on the flying qualities requirements for small-scale RUAVs.

75 FR 32858 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Control of Nitrogen...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... Boilers and Process Heaters at Petroleum Refineries Correction In rule document 2010-13377 beginning on... limitations for Control [Insert page number any industrial boiler or Requirements. where the document process...

Oregon Department of Transportation research leader : fall 2008.

DOT National Transportation Integrated Search

2008-01-01

The newsletter includes: : 1) To ensure safe travel through construction work zones, Traffic Control Plans (TCPs) are developed to communicate required traffic control measures to the construction team. The quality of the design and implementation of...

Air Quality Monitoring: Risk-Based Choices

NASA Technical Reports Server (NTRS)

James, John T.

2009-01-01

Air monitoring is secondary to rigid control of risks to air quality. Air quality monitoring requires us to target the credible residual risks. Constraints on monitoring devices are severe. Must transition from archival to real-time, on-board monitoring. Must provide data to crew in a way that they can interpret findings. Dust management and monitoring may be a major concern for exploration class missions.

Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital.

PubMed

Iqbal, Sahar; Mustansar, Tazeen

2017-03-01

Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found <3. The lowest value for sigma was found for chloride (1.1) at L2. The highest value of sigma was found for creatinine (10.1) at L3. HDL was found with the highest sigma values at both control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value <3 are required strict monitoring and modification in quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.

Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target.

PubMed

Hens, Koen; Berth, Mario; Armbruster, Dave; Westgard, Sten

2014-07-01

Six Sigma metrics were used to assess the analytical quality of automated clinical chemistry and immunoassay tests in a large Belgian clinical laboratory and to explore the importance of the source used for estimation of the allowable total error. Clinical laboratories are continually challenged to maintain analytical quality. However, it is difficult to measure assay quality objectively and quantitatively. The Sigma metric is a single number that estimates quality based on the traditional parameters used in the clinical laboratory: allowable total error (TEa), precision and bias. In this study, Sigma metrics were calculated for 41 clinical chemistry assays for serum and urine on five ARCHITECT c16000 chemistry analyzers. Controls at two analyte concentrations were tested and Sigma metrics were calculated using three different TEa targets (Ricos biological variability, CLIA, and RiliBÄK). Sigma metrics varied with analyte concentration, the TEa target, and between/among analyzers. Sigma values identified those assays that are analytically robust and require minimal quality control rules and those that exhibit more variability and require more complex rules. The analyzer to analyzer variability was assessed on the basis of Sigma metrics. Six Sigma is a more efficient way to control quality, but the lack of TEa targets for many analytes and the sometimes inconsistent TEa targets from different sources are important variables for the interpretation and the application of Sigma metrics in a routine clinical laboratory. Sigma metrics are a valuable means of comparing the analytical quality of two or more analyzers to ensure the comparability of patient test results.

29 CFR 1910.7 - Definition and requirements for a nationally recognized testing laboratory.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., written testing procedures, and calibration and quality control programs) to perform: (i) Testing and... test standards; or (ii) Experimental testing and examining of equipment and materials for workplace..., labeled, or accepted, the following controls or services: (i) Implements control procedures for...

76 FR 6331 - Approval and Disapproval and Promulgation of Air Quality Implementation Plans; Colorado; Revision...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... innovative control technology as an alternative to BACT requirements and make other changes as described in... Reasonably Available Control Technology, the initials BACT mean or refer to Best Available Control Technology... definitions also included the definition of Pollution Control Projects at existing electric utility steam...

Quality Space and Launch Requirements, Addendum to AS9100C

DTIC Science & Technology

2015-05-08

45 8.9.1 Statistical Process Control (SPC) .......................................................................... 45...SMC Space and Missile Systems Center SME Subject Matter Expert SOW Statement of Work SPC Statistical Process Control SPO System Program Office SRP...occur without any individual data exceeding the control limits. Control limits are developed using standard statistical methods or other approved

HVAC System Automatic Controls and Indoor Air Quality in Schools. Technical Bulletin.

ERIC Educational Resources Information Center

Wheeler, Arthur E.

Fans, motors, coils, and other control components enable a heating, ventilating, and air-conditioning (HVAC) system to function smoothly. An explanation of these control components and how they make school HVAC systems work is provided. Different systems may be compared by counting the number of controlled devices that are required. Control…

12 CFR 1815.115 - OMB control number.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 9 2013-01-01 2013-01-01 false OMB control number. 1815.115 Section 1815.115... ENVIRONMENTAL QUALITY § 1815.115 OMB control number. The collection of information requirements in this part have been approved by the Office of Management and Budget and assigned OMB control number 1505-0153...

77 FR 36137 - Airworthiness Directives; AGUSTA S.p.A. Helicopters

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... the upper end of collective control rod C2 to torque tube C3 is properly installed. This AD is... prevent separation of the collective control rod from the torque tube, loss of control of the collective... helicopters because the production quality control procedures did not require recording the applied torque on...

The vaccines consistency approach project: an EPAA initiative.

PubMed

De Mattia, F; Hendriksen, C; Buchheit, K H; Chapsal, J M; Halder, M; Lambrigts, D; Redhead, K; Rommel, E; Scharton-Kersten, T; Sesardic, T; Viviani, L; Ragan, I

2015-01-01

The consistency approach for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters during the whole production process. By using highly sensitive non-animal methods, the consistency approach has the potential to improve the quality of testing and to foster the 3Rs (replacement, refinement and reduction of animal use) for quality control of established vaccines. This concept offers an alternative to the current quality control strategy which often requires large numbers of laboratory animals. In order to facilitate the introduction of the consistency approach for established human and veterinary vaccine quality control, the European Partnership for Alternatives to Animal Testing (EPAA) initiated a project, the "Vaccines Consistency Approach Project", aiming at developing and validating the consistency approach with stakeholders from academia, regulators, OMCLs, EDQM, European Commission and industry. This report summarises progress since the project's inception.

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

PubMed

Kim, Dae Un

2002-08-01

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

Face Recognition for Access Control Systems Combining Image-Difference Features Based on a Probabilistic Model

NASA Astrophysics Data System (ADS)

Miwa, Shotaro; Kage, Hiroshi; Hirai, Takashi; Sumi, Kazuhiko

We propose a probabilistic face recognition algorithm for Access Control System(ACS)s. Comparing with existing ACSs using low cost IC-cards, face recognition has advantages in usability and security that it doesn't require people to hold cards over scanners and doesn't accept imposters with authorized cards. Therefore face recognition attracts more interests in security markets than IC-cards. But in security markets where low cost ACSs exist, price competition is important, and there is a limitation on the quality of available cameras and image control. Therefore ACSs using face recognition are required to handle much lower quality images, such as defocused and poor gain-controlled images than high security systems, such as immigration control. To tackle with such image quality problems we developed a face recognition algorithm based on a probabilistic model which combines a variety of image-difference features trained by Real AdaBoost with their prior probability distributions. It enables to evaluate and utilize only reliable features among trained ones during each authentication, and achieve high recognition performance rates. The field evaluation using a pseudo Access Control System installed in our office shows that the proposed system achieves a constant high recognition performance rate independent on face image qualities, that is about four times lower EER (Equal Error Rate) under a variety of image conditions than one without any prior probability distributions. On the other hand using image difference features without any prior probabilities are sensitive to image qualities. We also evaluated PCA, and it has worse, but constant performance rates because of its general optimization on overall data. Comparing with PCA, Real AdaBoost without any prior distribution performs twice better under good image conditions, but degrades to a performance as good as PCA under poor image conditions.

42 CFR 493.1423 - Standard; Testing personnel qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

78 FR 63093 - Approval and Promulgation of Air Quality Implementation Plans; Indiana

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... section of 326 IAC Article 7 concerning sulfur dioxide compliance monitoring requirements. On September 6... monitoring and sulfur dioxide control requirements in Indiana SIP. In addition to 326 IAC 1-2-23.5, the State... 63095

Guidance and Control Software Project Data - Volume 4: Configuration Management and Quality Assurance Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes configuration management and quality assurance documents from the GCS project. Volume 4 contains six appendices: A. Software Accomplishment Summary for the Guidance and Control Software Project; B. Software Configuration Index for the Guidance and Control Software Project; C. Configuration Management Records for the Guidance and Control Software Project; D. Software Quality Assurance Records for the Guidance and Control Software Project; E. Problem Report for the Pluto Implementation of the Guidance and Control Software Project; and F. Support Documentation Change Reports for the Guidance and Control Software Project.

Development and implementation of an automated quantitative film digitizer quality control program

NASA Astrophysics Data System (ADS)

Fetterly, Kenneth A.; Avula, Ramesh T. V.; Hangiandreou, Nicholas J.

1999-05-01

A semi-automated, quantitative film digitizer quality control program that is based on the computer analysis of the image data from a single digitized test film was developed. This program includes measurements of the geometric accuracy, optical density performance, signal to noise ratio, and presampled modulation transfer function. The variability of the measurements was less than plus or minus 5%. Measurements were made on a group of two clinical and two laboratory laser film digitizers during a trial period of approximately four months. Quality control limits were established based on clinical necessity, vendor specifications and digitizer performance. During the trial period, one of the digitizers failed the performance requirements and was corrected by calibration.

Computer applications in scientific balloon quality control

NASA Astrophysics Data System (ADS)

Seely, Loren G.; Smith, Michael S.

Seal defects and seal tensile strength are primary determinants of product quality in scientific balloon manufacturing; they therefore require a unit of quality measure. The availability of inexpensive and powerful data-processing tools can serve as the basis of a quality-trends-discerning analysis of products. The results of one such analysis are presently given in graphic form for use on the production floor. Software descriptions and their sample outputs are presented, together with a summary of overall and long-term effects of these methods on product quality.

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

USGS Publications Warehouse

Dodge, Kent A.; Lambing, John H.

2006-01-01

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

46 CFR 160.050-5 - Sampling, tests, and inspection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

46 CFR 160.050-5 - Sampling, tests, and inspection.

Code of Federal Regulations, 2014 CFR

2014-10-01

... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

46 CFR 160.050-5 - Sampling, tests, and inspection.

Code of Federal Regulations, 2012 CFR

2012-10-01

... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

46 CFR 160.050-5 - Sampling, tests, and inspection.

Code of Federal Regulations, 2013 CFR

2013-10-01

... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

46 CFR 160.050-5 - Sampling, tests, and inspection.

Code of Federal Regulations, 2011 CFR

2011-10-01

... satisfied that the ring life buoys meet this subpart. Each lot must demonstrate— (1) First quality... MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoy, Life Ring, Unicellular... necessary to maintain quality control and to monitor compliance with the requirements of this subchapter. (b...

76 FR 6559 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations... Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year Emissions Inventory, Reasonable... revision. EPA is approving this SIP revision because it satisfies Clean Air Act (CAA) requirements for the...

Environmental Assessment for Clean and Stabilize Ditches at the Golf Course and C Street

DTIC Science & Technology

2003-08-01

proposed action would require the disturbance of installation property, minimal decrease in storm water quality during the cleaning and a temporary...increase in noise levels during construction. Storm water quality would improve following the cleaning and stabilization. Erosion and sediment controls

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.

Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial.

PubMed

Legemate, Catherine M; Goei, Harold; Middelkoop, Esther; Oen, Irma M M H; Nijhuis, Tim H J; Kwa, Kelly A A; van Zuijlen, Paul P M; Beerthuizen, Gerard I J M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van der Vlies, Cornelis H

2018-04-19

Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound < 50 cm 2 , total body surface area (TBSA) burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds. Dutch Trial Register, NTR6232 . Registered on 23 January 2017.

Benefits and Costs of Pulp and Paper Effluent Controls Under the Clean Water Act

NASA Astrophysics Data System (ADS)

Luken, Ralph A.; Johnson, F. Reed; Kibler, Virginia

1992-03-01

This study quantifies local improvements in environmental quality from controlling effluents in the pulp and paper industry. Although it is confined to a single industry, this study is the first effort to assess the actual net benefits of the Clean Water Act pollution control program. An assessment of water quality benefits requires linking regulatory policy, technical effects, and behavioral responses. Regulatory policies mandate specific controls that influence the quantity and nature of effluent discharges. We identify a subset of stream segments suitable for analysis, describe water quality simulations and control cost calculations under alternative regulatory scenarios, assign feasible water uses to each segment based on water quality, and determine probable upper bounds for the willingness of beneficiaries to pay. Because the act imposes uniform regulations that do not account for differences in compliance costs, existing stream quality, contributions of other effluent sources, and recreation potential, the relation between water quality benefits and costs varies widely across sites. This variation suggests that significant positive net benefits have probably been achieved in some cases, but we conclude that the costs of the Clean Water Act as a whole exceed likely benefits by a significant margin.

Chinese vaccine products go global: vaccine development and quality control.

PubMed

Xu, Miao; Liang, Zhenglun; Xu, Yinghua; Wang, Junzhi

2015-05-01

Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

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.

40 CFR Table 10 to Subpart Uuuu of... - Applicability of General Provisions to Subpart UUUU

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements; internal and external QA procedures for testing No. § 63.7(d) Testing Facilities Requirements for....; must keep quality control plan on record for 5 years; keep old versions for 5 years after revisions No...

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false State plan requirements. 431.806 Section 431.806 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Quality Control General...

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false State plan requirements. 431.806 Section 431.806 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Quality Control General...

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false State plan requirements. 431.806 Section 431.806 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Quality Control General...

42 CFR 431.806 - State plan requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false State plan requirements. 431.806 Section 431.806 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS STATE ORGANIZATION AND GENERAL ADMINISTRATION Quality Control General...

Internal quality control: best practice.

PubMed

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

2013-12-01

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

[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.

Summary Report for the Evaluation of Current QA Processes Within the FRMAC FAL and EPA MERL.

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

Shanks, Sonoya T.; Redding, Ted; Jaussi, Lynn

The Federal Radiological Monitoring and Assessment Center (FRMAC) relies on accurate and defensible analytical laboratory data to support its mission. Therefore, FRMAC must ensure that the environmental analytical laboratories providing analytical services maintain an ongoing capability to provide accurate analytical results to DOE. It is undeniable that the more Quality Assurance (QA) and Quality Control (QC) measures required of the laboratory, the less resources that are available for analysis of response samples. Being that QA and QC measures in general are understood to comprise a major effort related to a laboratory’s operations, requirements should only be considered if they aremore » deemed “value-added” for the FRMAC mission. This report provides observations of areas for improvement and potential interoperability opportunities in the areas of Batch Quality Control Requirements, Written Communications, Data Review Processes, Data Reporting Processes, along with the lessons learned as they apply to items in the early phase of a response that will be critical for developing a more efficient, integrated response for future interactions between the FRMAC and EPA assets.« less

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... accounting purposes including direct measurement weighing the petroleum coke fed into your process (by belt... used to ensure the accuracy of monthly petroleum coke consumption measurements. (c) For CO2 process... quality assurance and quality control of the supplier data, you must conduct an annual measurement of the...

77 FR 66945 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-08

... and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably Available Control... Implementation Plan (SIP) revision submitted by the State of New Hampshire. The revision establishes Reasonably... intended effect of this action is to approve these requirements into the New Hampshire SIP. This action is...

45 CFR 158.150 - Activities that improve health care quality.

Code of Federal Regulations, 2012 CFR

2012-10-01

... designed primarily to control or contain costs; (2) The pro rata share of expenses that are for lines of... improve quality must meet the following requirements: (1) The activity must be designed to: (i) Improve... primarily designed to: (i) Improve health outcomes including increasing the likelihood of desired outcomes...

Software quality assurance | News

Science.gov Websites

Measure was removed: "Sufficient level of detail in the requirements to develop test cases." ; This control measure was removed since the sufficient level of detail needed to develop test cases is recorded for all test cases. (Note: This is mandatory for applications graded with a High Quality Assurance

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward.

PubMed

Kay, Jack F

2012-08-01

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory. © 2012 John Wiley & Sons, Ltd.

Perceptions and misconceptions regarding the Joint Commission's view of quality monitoring.

PubMed

Patterson, C H

1989-10-01

The Joint Commission recently has revised its hospital standards for infection control to reflect more accurately current state-of-the-art practices. In addition, the Joint Commission's Agenda for Change initiatives include the development of clinical indicators; one of the topics that will be included in those clinical indicator sets will be infection control. How the hospital chooses to organize itself to conduct the historically required monitoring and evaluation of clinical patient care currently required by the standards of the Joint Commission is at the option of the hospital. How the hospital will organize and collect data specific to infection control indicators yet to be developed by the Joint Commission has not been determined and will not be defined until specific research and development projects are completed. The hospital is expected to have in place infection prevention, surveillance, and control programs; it also is expected to have in place a quality assurance program that focuses not only on solving identified problems but also on the improvement of patient care quality. How the hospitals organize and/or integrate these activities is also at its option. It is expected that qualified professionals will direct and enforce infection prevention, surveillance, and control practices; indicators for infection control can provide data that will help assess the relative success of those practices and activities. The Joint Commission is not developing the capability to judge, on its own part, the actual quality of care provided by an organization seeking accreditation. Rather, the Joint Commission is committed to developing more accurate means to evaluate the structures, processes, and outcomes of diagnosis and treatment activities, as well as their interrelationships. Clinical excellence is supported by quality in the organizational environment and the managerial and leadership contexts within which patient care is delivered. Both clinical and organizational excellence are essential components of quality, and the Joint Commission is convinced that it is appropriate and timely to undertake more direct assessments of both.

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

Kegel, T.M.

Calibration laboratories are faced with the need to become accredited or registered to one or more quality standards. One requirement common to all of these standards is the need to have in place a measurement assurance program. What is a measurement assurance program? Brian Belanger, in Measurement Assurance Programs: Part 1, describes it as a {open_quotes}quality assurance program for a measurement process that quantifies the total uncertainty of the measurements (both random and systematic components of error) with respect to national or designated standards and demonstrates that the total uncertainty is sufficiently small to meet the user`s requirements.{close_quotes} Rolf Schumachermore » is more specific in Measurement Assurance in Your Own Laboratory. He states, {open_quotes}Measurement assurance is the application of broad quality control principles to measurements of calibrations.{close_quotes} Here, the focus is on one important part of any measurement assurance program: implementation of statistical process control (SPC). Paraphrasing Juran`s Quality Control Handbook, a process is in statistical control if the only observed variations are those that can be attributed to random causes. Conversely, a process that exhibits variations due to assignable causes is not in a state of statistical control. Finally, Carrol Croarkin states, {open_quotes}In the measurement assurance context the measurement algorithm including instrumentation, reference standards and operator interactions is the process that is to be controlled, and its direct product is the measurement per se. The measurements are assumed to be valid if the measurement algorithm is operating in a state of control.{close_quotes} Implicit in this statement is the important fact that an out-of-control process cannot produce valid measurements. 7 figs.« less

Handling qualities effects of display latency

NASA Technical Reports Server (NTRS)

King, David W.

1993-01-01

Display latency is the time delay between aircraft response and the corresponding response of the cockpit displays. Currently, there is no explicit specification for allowable display lags to ensure acceptable aircraft handling qualities in instrument flight conditions. This paper examines the handling qualities effects of display latency between 70 and 400 milliseconds for precision instrument flight tasks of the V-22 Tiltrotor aircraft. Display delay effects on the pilot control loop are analytically predicted through a second order pilot crossover model of the V-22 lateral axis, and handling qualities trends are evaluated through a series of fixed-base piloted simulation tests. The results show that the effects of display latency for flight path tracking tasks are driven by the stability characteristics of the attitude control loop. The data indicate that the loss of control damping due to latency can be simply predicted from knowledge of the aircraft's stability margins, control system lags, and required control bandwidths. Based on the relationship between attitude control damping and handling qualities ratings, latency design guidelines are presented. In addition, this paper presents a design philosophy, supported by simulation data, for using flight director display augmentation to suppress the effects of display latency for delays up to 300 milliseconds.

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.

Quality Space and Launch Requirements Addendum to AS9100C

DTIC Science & Technology

2015-03-05

45 8.9.1 Statistical Process Control (SPC) .......................................................................... 45 8.9.1.1 Out of Control...Systems Center SME Subject Matter Expert SOW Statement of Work SPC Statistical Process Control SPO System Program Office SRP Standard Repair...individual data exceeding the control limits. Control limits are developed using standard statistical methods or other approved techniques and are based on

A multiple functional connector for high-resolution optical satellites

NASA Astrophysics Data System (ADS)

She, Fengke; Zheng, Gangtie

2017-11-01

For earth observation satellites, perturbations from actuators, such as CMGs and momentum wheels, and thermal loadings from support structures often have significant impact on the image quality of an optical. Therefore, vibration isolators and thermal deformation releasing devices nowadays often become important parts of an image satellite. However, all these devices will weak the connection stiffness between the optical instrument and the satellite bus structure. This will cause concern of the attitude control system design for worrying about possible negative effect on the attitude control. Therefore, a connection design satisfying all three requirements is a challenge of advanced image satellites. Chinese scientists have proposed a large aperture high-resolution satellite for earth observation. To meet all these requirements and ensure image quality, specified multiple function connectors are designed to meet these challenging requirements, which are: isolating vibration, releasing thermal deformation and ensuring whole satellite dynamic properties [1]. In this paper, a parallel spring guide flexure is developed for both vibration isolation and thermal deformation releasing. The stiffness of the flexure is designed to meet the vibration isolation requirement. To attenuate vibration, and more importantly to satisfy the stability requirement of the attitude control system, metal damping, which has many merits for space applications, are applied in this connecter to provide a high damping ratio and nonlinear stiffness. The capability of the connecter for vibration isolation and attenuation is validated through numerical simulation and experiments. Connecter parameter optimization is also conducted to meet both requirements of thermal deformation releasing and attitude control. Analysis results show that the in-orbit attitude control requirement is satisfied while the thermal releasing performance is optimized. The design methods and analysis results are also provided in the present paper.

Historical overview of V/STOL aircraft technology

NASA Technical Reports Server (NTRS)

Anderson, S. B.

1981-01-01

The requirements for satisfactory characteristics in several key technology areas are discussed and a review is made of various V/STOL aircraft for the purpose of assessing the success or failure of each design in meeting design requirements. Special operating techniques were developed to help circumvent deficiencies. For the most part performance and handling qualities limitations restricted operational evaluations. Flight operations emphasized the need for good STOL performance, good handling qualities, and stability and control augmentation. The majority of aircraft suffered adverse ground effects.

Total quality management in American industry.

PubMed

Widtfeldt, A K; Widtfeldt, J R

1992-07-01

The definition of total quality management is conformance to customer requirements and specifications, fitness for use, buyer satisfaction, and value at an affordable price. The three individuals who have developed the total quality management concepts in the United States are W.E. Deming, J.M. Juran, and Philip Crosby. The universal principles of total quality management are (a) a customer focus, (b) management commitment, (c) training, (d) process capability and control, and (e) measurement through quality improvement tools. Results from the National Demonstration Project on Quality Improvement in Health Care showed the principles of total quality management could be applied to healthcare.

Rocky Mountain Arsenal, Sanitary Sewer Interim Response Action, Construction Documents for New Sanitary Sewer Construction. Volume 2

DTIC Science & Technology

1990-05-01

curves ; test reports; test cylinders: samples, O&M manuals including parts lists; certifications; warranties and other such required submittals...purpose. 14.4.3. Authority and responsibilities of all quality control personnel. 14.4.4. Schedule of Use of inspection personnel by types and phase of...quality control program shall include four phases of inspection and tests. The Contracting Officer’s representative shall be notified at least 24

[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.

ISO 9000 and/or Systems Engineering Capability Maturity Model?

NASA Technical Reports Server (NTRS)

Gholston, Sampson E.

2002-01-01

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

78 FR 12323 - Announcement of the Re-Approval of the Commission on Office Laboratory Accreditation (COLA) as an...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology... CLIA for the following specialties and subspecialties: Microbiology, including Bacteriology... requirements. The COLA requires the laboratory director to review quality control results for waived tests...

Handling Qualities of a Large Civil Tiltrotor in Hover using Translational Rate Command

NASA Technical Reports Server (NTRS)

Malpica, Carlos A.; Theodore, Colin R.; Lawrence, Ben; Lindsey, James; Blanken, Chris

2012-01-01

A Translational Rate Command (TRC) control law has been developed to enable low speed maneuvering of a large civil tiltrotor with minimal pitch changes by means of automatic nacelle angle deflections for longitudinal velocity control. The nacelle actuator bandwidth required to achieve Level 1 handling qualities in hover and the feasibility of additional longitudinal cyclic control to augment low bandwidth nacelle actuation were investigated. A frequency-domain handling qualities criterion characterizing TRC response in terms of bandwidth and phase delay was proposed and validated against a piloted simulation conducted on the NASA-Ames Vertical Motion Simulator. Seven experimental test pilots completed evaluations in the ADS-33E-PRF Hover Mission Task Element (MTE) for a matrix of nacelle actuator bandwidths, equivalent rise times and control response sensitivities, and longitudinal cyclic control allocations. Evaluated against this task, longitudinal phase delay shows the Level 1 boundary is around 0.4 0.5 s. Accordingly, Level 1 handling qualities were achieved either with a nacelle actuator bandwidth greater than 4 rad/s, or by employing longitudinal cyclic control to augment low bandwidth nacelle actuation.

Development of quality control and instrumentation performance metrics for diffuse optical spectroscopic imaging instruments in the multi-center clinical environment

NASA Astrophysics Data System (ADS)

Keene, Samuel T.; Cerussi, Albert E.; Warren, Robert V.; Hill, Brian; Roblyer, Darren; Leproux, AnaÑ--s.; Durkin, Amanda F.; O'Sullivan, Thomas D.; Haghany, Hosain; Mantulin, William W.; Tromberg, Bruce J.

2013-03-01

Instrument equivalence and quality control are critical elements of multi-center clinical trials. We currently have five identical Diffuse Optical Spectroscopic Imaging (DOSI) instruments enrolled in the American College of Radiology Imaging Network (ACRIN, #6691) trial located at five academic clinical research sites in the US. The goal of the study is to predict the response of breast tumors to neoadjuvant chemotherapy in 60 patients. In order to reliably compare DOSI measurements across different instruments, operators and sites, we must be confident that the data quality is comparable. We require objective and reliable methods for identifying, correcting, and rejecting low quality data. To achieve this goal, we developed and tested an automated quality control algorithm that rejects data points below the instrument noise floor, improves tissue optical property recovery, and outputs a detailed data quality report. Using a new protocol for obtaining dark-noise data, we applied the algorithm to ACRIN patient data and successfully improved the quality of recovered physiological data in some cases.

Social Media Use, Friendship Quality, and the Moderating Role of Anxiety in Adolescents with Autism Spectrum Disorder.

PubMed

van Schalkwyk, Gerrit I; Marin, Carla E; Ortiz, Mayra; Rolison, Max; Qayyum, Zheala; McPartland, James C; Lebowitz, Eli R; Volkmar, Fred R; Silverman, Wendy K

2017-09-01

Social media holds promise as a technology to facilitate social engagement, but may displace offline social activities. Adolescents with ASD are well suited to capitalize on the unique features of social media, which requires less decoding of complex social information. In this cross-sectional study, we assessed social media use, anxiety and friendship quality in 44 adolescents with ASD, and 56 clinical comparison controls. Social media use was significantly associated with high friendship quality in adolescents with ASD, which was moderated by the adolescents' anxiety levels. No associations were founds between social media use, anxiety and friendship quality in the controls. Social media may be a way for adolescents with ASD without significant anxiety to improve the quality of their friendships.

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.

Application Research of Quality Control Technology of Asphalt Pavement based on GPS Intelligent

NASA Astrophysics Data System (ADS)

Wang, Min; Gao, Bo; Shang, Fei; Wang, Tao

2017-10-01

Due to the difficulty of steel deck pavement asphalt layer compaction caused by the effect of the flexible supporting system (orthotropic steel deck plate), it is usually hard and difficult to control for the site compactness to reach the design goal. The intelligent compaction technology is based on GPS control technology and real-time acquisition of actual compaction tracks, and then forms a cloud maps of compaction times, which guide the roller operator to do the compaction in accordance with the design requirement to ensure the deck compaction technology and compaction quality. From the actual construction situation of actual bridge and checked data, the intelligent compaction technology is significant in guaranteeing the steel deck asphalt pavement compactness and quality stability.

Method of control position of laser focus during surfacing teeth of cutters

NASA Astrophysics Data System (ADS)

Zvezdin, V. V.; Hisamutdinov, R. M.; Rakhimov, R. R.; Israfilov, I. H.; Akhtiamov, R. F.

2017-09-01

Providing the quality laser of surfacing the edges of teeth requires control not only the energy of the radiation parameters, but also the position of the focal spot. The control channel of position of laser focus during surfacing, which determines the parameters of quality of the deposited layer, was calculated in the work. The parameters of the active opto-electronic system for the subsystem adjust the focus position relative to the deposited layer with a laser illumination of the cutting edges the teeth cutters were calculated, the model of a control channel based on thermal phenomena occurring in the zone of surfacing was proposed.

78 FR 9648 - Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Regulations (DCMR) for the Control of Volatile Organic Compounds (VOC) to meet the requirement to adopt reasonably available control technology (RACT) for sources as recommended by the Ozone Transport Commission (OTC) model rules and EPA's Control Techniques Guidelines (CTG) standards. On January 26, 2010 and...

76 FR 59600 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

...? A. Fine Particulate Standards and Regional Emission Controls B. Background for Indiana's PM 2.5... CAA. The maintenance plan, as revised in the May 26, 2011, submittal, assumes that control of power... replace existing power plant emission control requirements that would have resulted from EPA's Clean Air...

78 FR 48103 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Redesignation of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... Redesignation Request ii. Subpart 4 Requirements and Illinois' Redesignation Request iii. Subpart 4 and Control... due to permanent and enforceable emission reductions? 1. Permanent and Enforceable Controls a. Federal Emission Control Measures i. Tier 2 Emission Standards for Vehicles and Gasoline Sulfur Standards ii. Heavy...

Diagnosis of the Computer-Controlled Milling Machine, Definition of the Working Errors and Input Corrections on the Basis of Mathematical Model

NASA Astrophysics Data System (ADS)

Starikov, A. I.; Nekrasov, R. Yu; Teploukhov, O. J.; Soloviev, I. V.; Narikov, K. A.

2016-10-01

Manufactures, machinery and equipment improve of constructively as science advances and technology, and requirements are improving of quality and longevity. That is, the requirements for surface quality and precision manufacturing, oil and gas equipment parts are constantly increasing. Production of oil and gas engineering products on modern machine tools with computer numerical control - is a complex synthesis of technical and electrical equipment parts, as well as the processing procedure. Technical machine part wears during operation and in the electrical part are accumulated mathematical errors. Thus, the above-mentioned disadvantages of any of the following parts of metalworking equipment affect the manufacturing process of products in general, and as a result lead to the flaw.

Intelligent Control Approaches for Aircraft Applications

NASA Technical Reports Server (NTRS)

Gundy-Burlet, Karen; KrishnaKumar, K.; Soloway, Don; Kaneshige, John; Clancy, Daniel (Technical Monitor)

2001-01-01

This paper presents an overview of various intelligent control technologies currently being developed and studied under the Intelligent Flight Control (IFC) program at the NASA Ames Research Center. The main objective of the intelligent flight control program is to develop the next generation of flight controllers for the purpose of automatically compensating for a broad spectrum of damaged or malfunctioning aircraft components and to reduce control law development cost and time. The approaches being examined include: (a) direct adaptive dynamic inverse controller and (b) an adaptive critic-based dynamic inverse controller. These approaches can utilize, but do not require, fault detection and isolation information. Piloted simulation studies are performed to examine if the intelligent flight control techniques adequately: 1) Match flying qualities of modern fly-by-wire flight controllers under nominal conditions; 2) Improve performance under failure conditions when sufficient control authority is available; and 3) Achieve consistent handling qualities across the flight envelope and for different aircraft configurations. Results obtained so far demonstrate the potential for improving handling qualities and significantly increasing survivability rates under various simulated failure conditions.

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

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

Gilliam, T.M.

1991-05-01

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

Controllability of Complex Dynamic Objects

NASA Astrophysics Data System (ADS)

Kalach, G. G.; Kazachek, N. A.; Morozov, A. A.

2017-01-01

Quality requirements for mobile robots intended for both specialized and everyday use are increasing in step with the complexity of the technological tasks assigned to the robots. Whether a mobile robot is for ground, aerial, or underwater use, the relevant quality characteristics can be summarized under the common concept of agility. This term denotes the object’s (the robot)’s ability to react quickly to control actions (change speed and direction), turn in a limited area, etc. When using this approach in integrated assessment of the quality characteristics of an object with the control system, it seems more constructive to use the term “degree of control”. This paper assesses the degree of control by an example of a mobile robot with the variable-geometry drive wheel axle. We show changes in the degree of control depending on the robot’s configuration, and results illustrated by calculation data, computer and practical experiments. We describe the prospects of using intelligent technology for efficient control of objects with a high degree of controllability.

46 CFR 164.013-6 - Production tests, inspections, and marking.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Foam, Unicellular Polyethylene (Buoyant... shall provide in-plant quality control of polyethylene foam in accordance with the requirements of § 164.019-13 and any requirements of the recognized laboratory. The manufacturer of the foam has primary...

46 CFR 164.013-6 - Production tests, inspections, and marking.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Foam, Unicellular Polyethylene (Buoyant... shall provide in-plant quality control of polyethylene foam in accordance with the requirements of § 164.019-13 and any requirements of the recognized laboratory. The manufacturer of the foam has primary...

78 FR 67327 - Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Revised...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... shall include procedures for interagency consultation, conflict resolution, and public consultation... Determinations by the public, Air Quality Control Commission, and resolution of conflicts''. (2) 40 CFR 93.122(a... of 93.105(d) require specific procedures for resolving conflicts, and the provisions of 93.105(e...

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

ERIC Educational Resources Information Center

Espy, John

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

40 CFR 141.521 - What updated watershed control requirements must my unfiltered system implement to continue to...

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Identify watershed characteristics and activities which may have an adverse effect on source water quality; and (b) Monitor the occurrence of activities which may have an adverse effect on source water quality. ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) NATIONAL...