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...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

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

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.

[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.

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...

[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.

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 111.123 - 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...

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...

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...

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.

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...

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.

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...

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...

[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.

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...

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.

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...

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...

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...

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...

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.

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...

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

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

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.

[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.

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...

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 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.

Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

PubMed Central

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

2013-01-01

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

Cost effectiveness of adopted quality requirements in hospital laboratories.

PubMed

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

2013-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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...

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

PubMed

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

2017-01-01

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

A 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.

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.

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...

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

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...

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.

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

7 CFR 58.446 - Quality requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

7 CFR 160.11 - Quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Quality 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.

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.

7 CFR 58.530 - Keeping quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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.

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

DTIC Science & Technology

2005-03-01

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

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...

48 CFR 46.202 - Types of contract quality requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 46.202 Types of contract quality requirements. Contract quality requirements fall into four general categories, depending on the extent of... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Types of contract quality...

[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.

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...

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.

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.

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

Code of Federal Regulations, 2013 CFR

2013-10-01

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

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

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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

Code of Federal Regulations, 2011 CFR

2011-10-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

78 FR 7816 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

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

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...

Internal quality control: planning and implementation strategies.

PubMed

Westgard, James O

2003-11-01

The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

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

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 Leadership and Quality Control

PubMed Central

Badrick, Tony

2003-01-01

Different quality control rules detect different analytical errors with varying levels of efficiency depending on the type of error present, its prevalence and the number of observations. The efficiency of a rule can be gauged by inspection of a power function graph. Control rules are only part of a process and not an end in itself; just as important are the trouble-shooting systems employed when a failure occurs. 'Average of patient normals' may develop as a usual adjunct to conventional quality control serum based programmes. Acceptable error can be based on various criteria; biological variation is probably the most sensible. Once determined, acceptable error can be used as limits in quality control rule systems. A key aspect of an organisation is leadership, which links the various components of the quality system. Leadership is difficult to characterise but its key aspects include trust, setting an example, developing staff and critically setting the vision for the organisation. Organisations also have internal characteristics such as the degree of formalisation, centralisation, and complexity. Medical organisations can have internal tensions because of the dichotomy between the bureaucratic and the shadow medical structures. PMID:18568046

48 CFR 246.202 - Types of contract quality requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 246.202 Types of contract quality requirements. ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Types of contract quality...

48 CFR 246.202-4 - Higher-level contract quality requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality requirements. 246.202-4 Section 246.202-4 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 246.202-4 Higher-level contract quality requirements. (1) Higher-level contract quality...

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...

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 51.190 - Ambient air quality monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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.

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

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

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

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

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

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

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

Spectrum analysis on quality requirements consideration in software design documents.

PubMed

Kaiya, Haruhiko; Umemura, Masahiro; Ogata, Shinpei; Kaijiri, Kenji

2013-12-01

Software quality requirements defined in the requirements analysis stage should be implemented in the final products, such as source codes and system deployment. To guarantee this meta-requirement, quality requirements should be considered in the intermediate stages, such as the design stage or the architectural definition stage. We propose a novel method for checking whether quality requirements are considered in the design stage. In this method, a technique called "spectrum analysis for quality requirements" is applied not only to requirements specifications but also to design documents. The technique enables us to derive the spectrum of a document, and quality requirements considerations in the document are numerically represented in the spectrum. We can thus objectively identify whether the considerations of quality requirements in a requirements document are adapted to its design document. To validate the method, we applied it to commercial software systems with the help of a supporting tool, and we confirmed that the method worked well.

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

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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

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.

Section 3: Quality and Value-Based Requirements

NASA Astrophysics Data System (ADS)

Mylopoulos, John

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

QUALITY CONTROLS FOR PCR

EPA Science Inventory

The purpose of this presentation is to present an overview of the quality control (QC) sections of a draft EPA document entitled, "Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples." This document has been prepared by th...

Impact of Requirements Quality on Project Success or Failure

NASA Astrophysics Data System (ADS)

Tamai, Tetsuo; Kamata, Mayumi Itakura

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

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.

42 CFR 475.103 - Requirements for performing quality improvement initiatives.

Code of Federal Regulations, 2014 CFR

2014-10-01

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

Quality control algorithms for rainfall measurements

NASA Astrophysics Data System (ADS)

Golz, Claudia; Einfalt, Thomas; Gabella, Marco; Germann, Urs

2005-09-01

One of the basic requirements for a scientific use of rain data from raingauges, ground and space radars is data quality control. Rain data could be used more intensively in many fields of activity (meteorology, hydrology, etc.), if the achievable data quality could be improved. This depends on the available data quality delivered by the measuring devices and the data quality enhancement procedures. To get an overview of the existing algorithms a literature review and literature pool have been produced. The diverse algorithms have been evaluated to meet VOLTAIRE objectives and sorted in different groups. To test the chosen algorithms an algorithm pool has been established, where the software is collected. A large part of this work presented here is implemented in the scope of the EU-project VOLTAIRE ( Validati on of mu ltisensors precipit ation fields and numerical modeling in Mediter ran ean test sites).

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

PubMed

Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

2014-02-01

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

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...

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.

Quality Assurance/Quality Control Jobs

NASA Astrophysics Data System (ADS)

Fanslau, Melody; Young, Janelle

The production of a quality and safe food product is essential to the success of any food manufacturing facility. Because of this great importance, a career in quality can be extremely rewarding. Without happy customers willing to buy a product, a company would not be able to survive. Quality issues such as foreign objects, spoiled or mislabeled product, failure to meet net weight requirements, or a recall can all turn customers away from buying a product. The food industry is a customer-driven market in which some consumers are brand loyal based on a history of high quality or in which a single bad experience with a product will turn them away for a lifetime. With this said, the main role of a quality department is to help ensure that quality issues such as these are eliminated or kept to a minimum to maintain or increase the number of customers purchasing their product.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-09

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

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

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...

Commercial jet fuel quality control

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

Strauss, K.H.

1995-05-01

The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

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…

Improving Reliability of Spectrum Analysis for Software Quality Requirements Using TCM

NASA Astrophysics Data System (ADS)

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

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

Requirements for satisfactory flying qualities of airplanes

NASA Technical Reports Server (NTRS)

Gilruth, R R

1943-01-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 52.346 - Air quality monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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...

Statistical quality control through overall vibration analysis

NASA Astrophysics Data System (ADS)

Carnero, M. ^a. Carmen; González-Palma, Rafael; Almorza, David; Mayorga, Pedro; López-Escobar, Carlos

2010-05-01

The present study introduces the concept of statistical quality control in automotive wheel bearings manufacturing processes. Defects on products under analysis can have a direct influence on passengers' safety and comfort. At present, the use of vibration analysis on machine tools for quality control purposes is not very extensive in manufacturing facilities. Noise and vibration are common quality problems in bearings. These failure modes likely occur under certain operating conditions and do not require high vibration amplitudes but relate to certain vibration frequencies. The vibration frequencies are affected by the type of surface problems (chattering) of ball races that are generated through grinding processes. The purpose of this paper is to identify grinding process variables that affect the quality of bearings by using statistical principles in the field of machine tools. In addition, an evaluation of the quality results of the finished parts under different combinations of process variables is assessed. This paper intends to establish the foundations to predict the quality of the products through the analysis of self-induced vibrations during the contact between the grinding wheel and the parts. To achieve this goal, the overall self-induced vibration readings under different combinations of process variables are analysed using statistical tools. The analysis of data and design of experiments follows a classical approach, considering all potential interactions between variables. The analysis of data is conducted through analysis of variance (ANOVA) for data sets that meet normality and homoscedasticity criteria. This paper utilizes different statistical tools to support the conclusions such as chi squared, Shapiro-Wilks, symmetry, Kurtosis, Cochran, Hartlett, and Hartley and Krushal-Wallis. The analysis presented is the starting point to extend the use of predictive techniques (vibration analysis) for quality control. This paper demonstrates the existence

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

PubMed

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

2017-12-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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. �

40 CFR 51.359 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

40 CFR 51.359 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

40 CFR 51.359 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

40 CFR 51.359 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

Quality control in gastrointestinal surgery.

PubMed

Ramírez-Barba, Ector Jaime; Arenas-Moya, Diego; Vázquez-Guerrero, Arturo

2011-01-01

We analyzed the Mexican legal framework, identifying the vectors that characterize quality and control in gastrointestinal surgery. Quality is contemplated in the health protection rights determined according to the Mexican Constitution, established in the general health law and included as a specific goal in the actual National Development Plan and Health Sector Plan. Quality control implies planning, verification and application of corrective measures. Mexico has implemented several quality strategies such as certification of hospitals and regulatory agreements by the General Salubrity Council, creation of the National Health Quality Committee, generation of Clinical Practice Guidelines and the Certification of Medical Specialties, among others. Quality control in gastrointestinal surgery must begin at the time of medical education and continue during professional activities of surgeons, encouraging multidisciplinary teamwork, knowledge, abilities, attitudes, values and skills that promote homogeneous, safe and quality health services for the Mexican population.

Quality Requirements for Teacher Educators

ERIC Educational Resources Information Center

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

2005-01-01

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

General aviation fuel quality control

NASA Technical Reports Server (NTRS)

Poitz, H.

1983-01-01

Quality control measures for aviation gasoline, and some of the differences between quality control on avgas and mogas are discussed. One thing to keep in mind is that with motor gasoline you can always pull off to the side of the road. It's not so easy to do in an airplane. Consequently, there are reasons for having the tight specifications and the tight quality control measures on avgas as compared to motor gasoline.

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

7 CFR 981.42 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

7 CFR 981.42 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

7 CFR 981.42 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

7 CFR 981.42 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

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...

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...

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...

Quality requirements for EHR archetypes.

PubMed

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

2012-01-01

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

[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.

14 CFR 21.139 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

14 CFR 21.139 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 3 2013-07-01 2013-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

40 CFR 136.7 - Quality assurance and quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 136.7 - Quality assurance and quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 136.7 - Quality assurance and quality control.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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...

48 CFR 46.311 - Higher-level contract quality requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Higher-level contract... REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Clauses 46.311 Higher-level contract quality requirement. The contracting officer shall insert the clause at 52.246-11, Higher-Level Contract Quality...

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.

[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.

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.

[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 131.6 - Minimum requirements for water quality standards submission.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

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.

7 CFR 58.335 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

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.

Quality Risk Management: Putting GMP Controls First.

PubMed

O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

2012-01-01

This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered

Satisfying regulatory and accreditation requirements for quality control.

PubMed

Ehrmeyer, Sharon S

2013-03-01

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA. Copyright © 2013 Elsevier Inc. All rights reserved.

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

PubMed

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

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

30 CFR 28.31 - Quality control plans; contents.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control plans; contents. 28.31 Section... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the management of quality, including: (1...

HPTLC Fingerprint Analysis: A Quality Control for Authentication of Herbal Phytochemicals

NASA Astrophysics Data System (ADS)

Ram, Mauji; Abdin, M. Z.; Khan, M. A.; Jha, Prabhakar

Authentication and consistent quality are the basic requirement for Indian traditional medicine (TIM), Chinese traditional herbal medicine (TCHM), and their commercial products, regardless of the kind of research conducted to modernize the TIM and TCHM. The complexities of TIM and TCHM challenge the current official quality control mode, for which only a few biochemical markers were selected for identification and quantitative assay. Referring too many unknown factors existed in TIM and TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug. Chromatographic fingerprint is a rational option to meet the need for more effective and powerful quality assessment to TIM and TCHM. The optimized chromatographic fingerprint is not only an alternative analytical tool for authentication, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such "database" for further multifaced sustainable studies. Analytical separation techniques, for example, high-performance liquid chromatography (HPLC), gas chromatography (GC) and mass spectrometry (MS) were among the most popular methods of choice used for quality control of raw material and finished herbal product. Fingerprint analysis approach using high-performance thin-layer chromatography (HPTLC) has become the most potent tool for quality control of herbal medicines because of its simplicity and reliability. It can serve as a tool for identification, authentication, and quality control of herbal drugs. In this chapter, attempts are being made to expand the use of HPTLC and at the same time create interest among prospective researcher in herbal analysis. The developed method can be used as a quality control tool for rapid authentication from a wide variety of herbal samples. Some examples demonstrated the role of fingerprinting in quality control and assessment.

Control by quality: proposition of a typology.

PubMed

Pujo, P; Pillet, M

The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control

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

PubMed

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

2016-02-15

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

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

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.

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Distributed sensor architecture for intelligent control that supports quality of control and quality of service.

PubMed

Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

2015-02-25

This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems.

Distributed Sensor Architecture for Intelligent Control that Supports Quality of Control and Quality of Service

PubMed Central

Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

2015-01-01

This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems. PMID:25723145

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

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

Quality control in the year 2000.

PubMed

Schade, B

1992-01-01

'Just-in-time' production is a prerequisite for a company to meet the challenges of competition. Manufacturing cycles have been so successfully optimized that release time now has become a significant factor. A vision for a major quality-control (QC) contribution to profitability in this decade seems to be the just-in-time release. Benefits will go beyond cost savings for lower inventory. The earlier detection of problems will reduce rejections and scrap. In addition, problem analysis and problem-solving will be easier. To achieve just-in-time release, advanced automated systems like robots will become the workhorses in QC for high volume pharmaceutical production. The requirements for these systems are extremely high in terms of quality, reliability and ruggedness. Crucial for the success might be advances in use of microelectronics for error checks, system recording, trouble shooting, etc. as well as creative new approaches (for example the use of redundant assay systems).

Quality control in the year 2000

PubMed Central

Schade, Bernd

1992-01-01

‘Just-in-time’ production is a prerequisite for a company to meet the challenges of competition. Manufacturing cycles have been so successfully optimized that release time now has become a significant factor. A vision for a major quality-control (QC) contribution to profitability in this decade seems to be the just-in-time release. Benefits will go beyond cost savings for lower inventory. The earlier detection of problems will reduce rejections and scrap. In addition, problem analysis and problem-solving will be easier. To achieve just-in-time release, advanced automated systems like robots will become the workhorses in QC for high volume pharmaceutical production. The requirements for these systems are extremely high in terms of quality, reliability and ruggedness. Crucial for the success might be advances in use of microelectronics for error checks, system recording, trouble shooting, etc. as well as creative new approaches (for example the use of redundant assay systems). PMID:18924930

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

42 CFR 84.41 - Quality control plans; contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

42 CFR 84.41 - Quality control plans; contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

42 CFR 84.41 - Quality control plans; contents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

42 CFR 84.41 - Quality control plans; contents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

42 CFR 84.41 - Quality control plans; contents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

Instrument Quality Control.

PubMed

Jayakody, Chatura; Hull-Ryde, Emily A

2016-01-01

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

14 CFR 145.211 - Quality control system.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

14 CFR 145.211 - Quality control system.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Quality Control in construction.

DTIC Science & Technology

1984-01-01

behavioral scientists. In 1962, Dr. Kaoru Ishikawa gave shape to the form of training which featured intradepartmental groups of ten or so workers seated...and Japanese circles bears closer scrutiny. 4.3.1 Japanese Ingredients of Quality The founder of quality circles, Dr. Kaoru Ishikawa , gives six...around 51 a table; hence the name Quality Control Circle. 4 Dr. 0 Ishikawa was an engineering professor at Tokyo University, and the circles were

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

Security Quality Requirements Engineering (SQUARE) Methodology

DTIC Science & Technology

2005-11-01

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

Guidance for Efficient Small Animal Imaging Quality Control.

PubMed

Osborne, Dustin R; Kuntner, Claudia; Berr, Stuart; Stout, David

2017-08-01

Routine quality control is a critical aspect of properly maintaining high-performance small animal imaging instrumentation. A robust quality control program helps produce more reliable data both for academic purposes and as proof of system performance for contract imaging work. For preclinical imaging laboratories, the combination of costs and available resources often limits their ability to produce efficient and effective quality control programs. This work presents a series of simplified quality control procedures that are accessible to a wide range of preclinical imaging laboratories. Our intent is to provide minimum guidelines for routine quality control that can assist preclinical imaging specialists in setting up an appropriate quality control program for their facility.

[Application of fingerprint chromatogram in quality control of Shen-Mai injection].

PubMed

Shi, Xian-zhe; Yang, Jun; Zhao, Chun-xia; Xiong, Jian-hui; Xu, Guo-wang

2002-07-01

The theory and practice of traditional Chinese medicine require some comprehensive methods to assess quality of the Chinese herbal medication. Fingerprint chromatogram is one of the feasible approaches to evaluate the quality of Chinese herbal medication. So the fingerprint chromatogram of Shen-Mai injection was established by using reversed-phase high performance liquid chromatography. The chromatographic conditions were as follows: a Hypersil C18 column was used; the mobile phase was composed of water (A) and acetontrile (B) with linear gradient elution (0-50 min, 5%-95% B, volume fraction); the flow rate was 1.0 mL/min and the UV absorbance detection was set at 202 nm. The peak-area ratios of twenty-three fingerprint peaks and internal standard (diphenyl) were taken as the criteria for quality control. The quality differences in various batches and various manufacturers of Shen-Mai injections were investigated by projection discriminance based on principal component analysis. The results show the method developed is convenient, reliable and applicable for the quality control analysis of Shen-Mai injection.

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

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...

Quality-Assurance/Quality-Control Manual for Collection and Analysis of Water-Quality Data in the Ohio District, US Geological Survey

USGS Publications Warehouse

Francy, D.S.; Jones, A.L.; Myers, Donna N.; Rowe, G.L.; Eberle, Michael; Sarver, K.M.

1998-01-01

The U.S. Geological Survey (USGS), Water Resources Division (WRD), requires that quality-assurance/quality-control (QA/QC) activities be included in any sampling and analysis program. Operational QA/QC procedures address local needs while incorporating national policies. Therefore, specific technical policies were established for all activities associated with water-quality project being done by the Ohio District. The policies described in this report provide Ohio District personnel, cooperating agencies, and others with a reference manual on QA/QC procedures that are followed in collecitng and analyzing water-quality samples and reporting water-quality information in the Ohio District. The project chief, project support staff, District Water-Quality Specialist, and District Laboratory Coordinator are all involved in planning and implementing QA/QC activities at the district level. The District Chief and other district-level managers provide oversight, and the Regional Water-Quality Specialist, Office of Water Quality (USGS headquarters), and the Branch of Quality Systems within the Office of Water Quality create national QA/QC polices and provide assistance to District personnel. In the literature, the quality of all measurement data is expressed in terms of precision, variability, bias, accuracy, completeness, representativeness, and comparability. In the Ohio District, bias and variability will be used to describe quality-control data generated from samples in the field and laboratory. Each project chief must plan for implementation and financing of QA/QC activities necessary to achieve data-quality objectives. At least 15 percent of the total project effort must be directed toward QA/QC activities. Of this total, 5-10 percent will be used for collection and analysis of quality-control samples. This is an absolute minimum, and more may be required based on project objectives. Proper techniques must be followed in the collection and processing of surface

Sci-Fri AM: Quality, Safety, and Professional Issues 01: CPQR Technical Quality Control Suite Development including Quality Control Workload Results

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

Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing and ratification by COMP. The adopted framework for the development and maintenance of themore » TQCs ensures the guidelines incorporate input from the medical physics community during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e. “living documents”) through subsequent planned reviews and updates. This presentation will show the Multi-Leaf Linear Accelerator document as an example of how feedback and cross-national work to achieve a robust guidance document. During field-testing, each technology was tested at multiple centres in a variety of clinic environments. As part of the defined feedback, workload data was captured. This lead to average time associated with testing as defined in each TQC document. As a result, for a medium-sized centre comprising 6 linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicist per year to complete all QC tests listed in this suite.« less

40 CFR 65.42 - Control requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Control requirements. 65.42 Section 65...) CONSOLIDATED FEDERAL AIR RULE Storage Vessels § 65.42 Control requirements. (a) For each storage vessel to... periods of planned routine maintenance or during a control system malfunction. The owner or operator shall...

40 CFR 65.42 - Control requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 16 2014-07-01 2014-07-01 false Control requirements. 65.42 Section 65...) CONSOLIDATED FEDERAL AIR RULE Storage Vessels § 65.42 Control requirements. (a) For each storage vessel to... periods of planned routine maintenance or during a control system malfunction. The owner or operator shall...

40 CFR 65.42 - Control requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 16 2013-07-01 2013-07-01 false Control requirements. 65.42 Section 65...) CONSOLIDATED FEDERAL AIR RULE Storage Vessels § 65.42 Control requirements. (a) For each storage vessel to... periods of planned routine maintenance or during a control system malfunction. The owner or operator shall...

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...

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

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality

77 FR 18709 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources AGENCY... direct final rule titled ``Quality Assurance Requirements for Continuous Opacity Monitoring Systems at...--Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources Docket, EPA...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2013-01-01 2013-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2012-01-01 2012-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

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.

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.

Proteomics Quality Control: Quality Control Software for MaxQuant Results.

PubMed

Bielow, Chris; Mastrobuoni, Guido; Kempa, Stefan

2016-03-04

Mass spectrometry-based proteomics coupled to liquid chromatography has matured into an automatized, high-throughput technology, producing data on the scale of multiple gigabytes per instrument per day. Consequently, an automated quality control (QC) and quality analysis (QA) capable of detecting measurement bias, verifying consistency, and avoiding propagation of error is paramount for instrument operators and scientists in charge of downstream analysis. We have developed an R-based QC pipeline called Proteomics Quality Control (PTXQC) for bottom-up LC-MS data generated by the MaxQuant software pipeline. PTXQC creates a QC report containing a comprehensive and powerful set of QC metrics, augmented with automated scoring functions. The automated scores are collated to create an overview heatmap at the beginning of the report, giving valuable guidance also to nonspecialists. Our software supports a wide range of experimental designs, including stable isotope labeling by amino acids in cell culture (SILAC), tandem mass tags (TMT), and label-free data. Furthermore, we introduce new metrics to score MaxQuant's Match-between-runs (MBR) functionality by which peptide identifications can be transferred across Raw files based on accurate retention time and m/z. Last but not least, PTXQC is easy to install and use and represents the first QC software capable of processing MaxQuant result tables. PTXQC is freely available at https://github.com/cbielow/PTXQC .

7 CFR 981.442 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

7 CFR 981.442 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

7 CFR 981.442 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

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.

Contributions of CCLM to advances in quality control.

PubMed

Kazmierczak, Steven C

2013-01-01

Abstract The discipline of laboratory medicine is relatively young when considered in the context of the history of medicine itself. The history of quality control, within the context of laboratory medicine, also enjoys a relatively brief, but rich history. Laboratory quality control continues to evolve along with advances in automation, measurement techniques and information technology. Clinical Chemistry and Laboratory Medicine (CCLM) has played a key role in helping disseminate information about the proper use and utility of quality control. Publication of important advances in quality control techniques and dissemination of guidelines concerned with laboratory quality control has undoubtedly helped readers of this journal keep up to date on the most recent developments in this field.

Quality-control issues on high-resolution diagnostic monitors.

PubMed

Parr, L F; Anderson, A L; Glennon, B K; Fetherston, P

2001-06-01

Previous literature indicates a need for more data collection in the area of quality control of high-resolution diagnostic monitors. Throughout acceptance testing, which began in June 2000, stability of monitor calibration was analyzed. Although image quality on all monitors was found to be acceptable upon initial acceptance testing using VeriLUM software by Image Smiths, Inc (Germantown, MD), it was determined to be unacceptable during the clinical phase of acceptance testing. High-resolution monitors were evaluated for quality assurance on a weekly basis from installation through acceptance testing and beyond. During clinical utilization determination (CUD), monitor calibration was identified as a problem and the manufacturer returned and recalibrated all workstations. From that time through final acceptance testing, high-resolution monitor calibration and monitor failure rate remained a problem. The monitor vendor then returned to the site to address these areas. Monitor defocus was still noticeable and calibration checks were increased to three times per week. White and black level drift on medium-resolution monitors had been attributed to raster size settings. Measurements of white and black level at several different size settings were taken to determine the effect of size on white and black level settings. Black level remained steady with size change. White level appeared to increase by 2.0 cd/m2 for every 0.1 inches decrease in horizontal raster size. This was determined not to be the cause of the observed brightness drift. Frequency of calibration/testing is an issue in a clinical environment. The increased frequency required at our site cannot be sustained. The medical physics division cannot provide dedicated personnel to conduct the quality-assurance testing on all monitors at this interval due to other physics commitments throughout the hospital. Monitor access is also an issue due to radiologists' need to read images. Some workstations are in use 7 AM

7 CFR 58.733 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

7 CFR 58.733 - Quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

Quality-control design for surface-water sampling in the National Water-Quality Network

USGS Publications Warehouse

Riskin, Melissa L.; Reutter, David C.; Martin, Jeffrey D.; Mueller, David K.

2018-04-10

The data-quality objectives for samples collected at surface-water sites in the National Water-Quality Network include estimating the extent to which contamination, matrix effects, and measurement variability affect interpretation of environmental conditions. Quality-control samples provide insight into how well the samples collected at surface-water sites represent the true environmental conditions. Quality-control samples used in this program include field blanks, replicates, and field matrix spikes. This report describes the design for collection of these quality-control samples and the data management needed to properly identify these samples in the U.S. Geological Survey’s national database.

Advanced strategies for quality control of Chinese medicines.

PubMed

Zhao, Jing; Ma, Shuang-Cheng; Li, Shao-Ping

2018-01-05

Quality control is always the critical issue for Chinese medicines (CMs) with their worldwide increasing use. Different from western medicine, CMs are usually considered that multiple constituents are responsible for the therapeutic effects. Therefore, quality control of CMs is a challenge. In 2011, the strategies for quantification, related to the markers, reference compounds and approaches, in quality control of CMs were reviewed (Li, et al., J. Pharm. Biomed. Anal., 2011, 55, 802-809). Since then, some new strategies have been proposed in these fields. Therefore, the review on the strategies for quality control of CMs should be updated to improve the safety and efficacy of CMs. Herein, novel strategies related to quality marker discovery, reference compound development and advanced approaches (focused on glyco-analysis) for quality control, during 2011-2016, were summarized and discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 864.8625 - Hematology quality control mixture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hematology quality control mixture. 864.8625 Section 864.8625 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... quality control mixture. (a) Identification. A hematology quality control mixture is a device used to...

Cellular Strategies of Protein Quality Control

PubMed Central

Chen, Bryan; Retzlaff, Marco; Roos, Thomas; Frydman, Judith

2011-01-01

Eukaryotic cells must contend with a continuous stream of misfolded proteins that compromise the cellular protein homeostasis balance and jeopardize cell viability. An elaborate network of molecular chaperones and protein degradation factors continually monitor and maintain the integrity of the proteome. Cellular protein quality control relies on three distinct yet interconnected strategies whereby misfolded proteins can either be refolded, degraded, or delivered to distinct quality control compartments that sequester potentially harmful misfolded species. Molecular chaperones play a critical role in determining the fate of misfolded proteins in the cell. Here, we discuss the spatial and temporal organization of cellular quality control strategies and their implications for human diseases linked to protein misfolding and aggregation. PMID:21746797

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Responsibilities of quality control unit. 211.22... Personnel § 211.22 Responsibilities of quality control unit. (a) There shall be a quality control unit that... have been fully investigated. The quality control unit shall be responsible for approving or rejecting...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Responsibilities of quality control unit. 211.22... Personnel § 211.22 Responsibilities of quality control unit. (a) There shall be a quality control unit that... have been fully investigated. The quality control unit shall be responsible for approving or rejecting...

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

NASA Technical Reports Server (NTRS)

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

1974-01-01

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

40 CFR 81.112 - Charleston Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.112 Charleston Intrastate Air Quality Control Region. The Charleston Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... Quality Control Region: Region 1. 81.107Greenwood Intrastate Air Quality Control Region: Region 2. 81...

40 CFR 81.112 - Charleston Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.112 Charleston Intrastate Air Quality Control Region. The Charleston Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... Quality Control Region: Region 1. 81.107Greenwood Intrastate Air Quality Control Region: Region 2. 81...

40 CFR 81.88 - Billings Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.88 Billings Intrastate Air Quality Control Region. The Metropolitan Billings Intrastate Air Quality Control Region (Montana) has been renamed the Billings Intrastate Air Quality Control... to by Montana authorities as follows: Sec. 481.168Great Falls Intrastate Air Quality Control Region...

40 CFR 81.88 - Billings Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.88 Billings Intrastate Air Quality Control Region. The Metropolitan Billings Intrastate Air Quality Control Region (Montana) has been renamed the Billings Intrastate Air Quality Control... to by Montana authorities as follows: Sec. 481.168Great Falls Intrastate Air Quality Control Region...

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.

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.

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

Code of Federal Regulations, 2010 CFR

2010-01-01

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

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

Code of Federal Regulations, 2011 CFR

2011-01-01

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

Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

PubMed

Djuris, Jelena; Djuric, Zorica

2017-11-30

Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Electronic health records. A systematic review on quality requirements.

PubMed

Hoerbst, A; Ammenwerth, E

2010-01-01

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

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.

7 CFR 58.141 - Alternate quality control program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Alternate quality control program. 58.141 Section 58... Service 1 Quality Specifications for Raw Milk § 58.141 Alternate quality control program. When a plant has in operation an acceptable quality program, at the producer level, which is approved by the...

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must quality control personnel do? 111.105... for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must... manufacturing record. To do so, quality control personnel must perform operations that include: (a) Approving or...

Theoretical approach to society-wide environmental quality control

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

Ayano, K.

1982-01-01

The study outlines the basis for a theory of societal control of environmental quality in the US based on the concepts and philosophy of company-wide quality control which has developed in Japan as a cross-disciplinary approach to problem-solving in the industrial realm. The basic concepts are: 1) every member of society, as a producer of environmental products and services for future generations, in principle has the responsibility to control the quality of his output; 2) environment quality is the quality of life, or the fitness of use of environment for humans; and 3) societal control is any activity necessary formore » quality production of environmental products and services continuously or in the long run. A motivator-hygiene theory of environmental quality is identified, and a proposal is made that the policy provision must be formulated differently between those aimed at hygiene factors of environmental quality and those aimed at motivators, the former in a collectivistic manner, the latter as an individual problem. The concept of societal cost of environmental quality is introduced. Based on the motivator-hygiene theory of environmental quality, the collectivistic and individual approaches are differentiated and discussed.« less

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...

Deriving proper measurement uncertainty from Internal Quality Control data: An impossible mission?

PubMed

Ceriotti, Ferruccio

2018-03-30

Measurement uncertainty (MU) is a "non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used". In the clinical laboratory the most convenient way to calculate MU is the "top down" approach based on the use of Internal Quality Control data. As indicated in the definition, MU depends on the information used for its calculation and so different estimates of MU can be obtained. The most problematic aspect is how to deal with bias. In fact bias is difficult to detect and quantify and it should be corrected including only the uncertainty derived from this correction. Several approaches to calculate MU starting from Internal Quality Control data are presented. The minimum requirement is to use only the intermediate precision data, provided to include 6 months of results obtained with a commutable quality control material at a concentration close to the clinical decision limit. This approach is the minimal requirement and it is convenient for all those measurands that are especially used for monitoring or where a reference measurement system does not exist and so a reference for calculating the bias is lacking. Other formulas including the uncertainty of the value of the calibrator, including the bias from a commutable certified reference material or from a material specifically prepared for trueness verification, including the bias derived from External Quality Assessment schemes or from historical mean of the laboratory are presented and commented. MU is an important parameter, but a single, agreed upon way to calculate it in a clinical laboratory is not yet available. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Quality Control in Higher Education.

ERIC Educational Resources Information Center

Hogarth, Charles P.

The status of quality control in U.S. higher education is discussed with an overview of the functions and structure of public and private colleges and universities. The book is divided into seven chapters: (1) outside controls (accrediting groups, governmental groups and other groups); (2) structure (board of control, president, organization); (3)…

46 CFR 63.20-1 - Specific control system requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

46 CFR 63.20-1 - Specific control system requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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.

Quality Control Technician.

ERIC Educational Resources Information Center

Ohio State Univ., Columbus. Center on Education and Training for Employment.

This document contains 18 units to consider for use in a tech prep competency profile for the occupation of quality control technician. All the units listed will not necessarily apply to every situation or tech prep consortium, nor will all the competencies within each unit be appropriate. Several units appear within each specific occupation and…

The medical director and quality requirements in the dialysis facility.

PubMed

Schiller, Brigitte

2015-03-06

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

Qualities Required from Engineers of the Global Times

NASA Astrophysics Data System (ADS)

Senuma, Takehide

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

40 CFR 81.77 - Puerto Rico Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

40 CFR 81.77 - Puerto Rico Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

40 CFR 81.77 - Puerto Rico Air Quality Control Region.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 18 2012-07-01 2012-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

40 CFR 81.77 - Puerto Rico Air Quality Control Region.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 18 2013-07-01 2013-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

Quality control and quality assurance in genotypic data for genome-wide association studies

PubMed Central

Laurie, Cathy C.; Doheny, Kimberly F.; Mirel, Daniel B.; Pugh, Elizabeth W.; Bierut, Laura J.; Bhangale, Tushar; Boehm, Frederick; Caporaso, Neil E.; Cornelis, Marilyn C.; Edenberg, Howard J.; Gabriel, Stacy B.; Harris, Emily L.; Hu, Frank B.; Jacobs, Kevin; Kraft, Peter; Landi, Maria Teresa; Lumley, Thomas; Manolio, Teri A.; McHugh, Caitlin; Painter, Ian; Paschall, Justin; Rice, John P.; Rice, Kenneth M.; Zheng, Xiuwen; Weir, Bruce S.

2011-01-01

Genome-wide scans of nucleotide variation in human subjects are providing an increasing number of replicated associations with complex disease traits. Most of the variants detected have small effects and, collectively, they account for a small fraction of the total genetic variance. Very large sample sizes are required to identify and validate findings. In this situation, even small sources of systematic or random error can cause spurious results or obscure real effects. The need for careful attention to data quality has been appreciated for some time in this field, and a number of strategies for quality control and quality assurance (QC/QA) have been developed. Here we extend these methods and describe a system of QC/QA for genotypic data in genome-wide association studies. This system includes some new approaches that (1) combine analysis of allelic probe intensities and called genotypes to distinguish gender misidentification from sex chromosome aberrations, (2) detect autosomal chromosome aberrations that may affect genotype calling accuracy, (3) infer DNA sample quality from relatedness and allelic intensities, (4) use duplicate concordance to infer SNP quality, (5) detect genotyping artifacts from dependence of Hardy-Weinberg equilibrium (HWE) test p-values on allelic frequency, and (6) demonstrate sensitivity of principal components analysis (PCA) to SNP selection. The methods are illustrated with examples from the ‘Gene Environment Association Studies’ (GENEVA) program. The results suggest several recommendations for QC/QA in the design and execution of genome-wide association studies. PMID:20718045

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.

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.

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2014 CFR

2014-04-01

... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Quality control...

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2013 CFR

2013-04-01

... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Quality control...

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2012 CFR

2012-04-01

... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Quality control...

Improving labeling efficiency in automatic quality control of MRSI data.

PubMed

Pedrosa de Barros, Nuno; McKinley, Richard; Wiest, Roland; Slotboom, Johannes

2017-12-01

To improve the efficiency of the labeling task in automatic quality control of MR spectroscopy imaging data. 28'432 short and long echo time (TE) spectra (1.5 tesla; point resolved spectroscopy (PRESS); repetition time (TR)= 1,500 ms) from 18 different brain tumor patients were labeled by two experts as either accept or reject, depending on their quality. For each spectrum, 47 signal features were extracted. The data was then used to run several simulations and test an active learning approach using uncertainty sampling. The performance of the classifiers was evaluated as a function of the number of patients in the training set, number of spectra in the training set, and a parameter α used to control the level of classification uncertainty required for a new spectrum to be selected for labeling. The results showed that the proposed strategy allows reductions of up to 72.97% for short TE and 62.09% for long TE in the amount of data that needs to be labeled, without significant impact in classification accuracy. Further reductions are possible with significant but minimal impact in performance. Active learning using uncertainty sampling is an effective way to increase the labeling efficiency for training automatic quality control classifiers. Magn Reson Med 78:2399-2405, 2017. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.

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

PubMed

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

2017-09-19

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

PACS quality control and automatic problem notifier

NASA Astrophysics Data System (ADS)

Honeyman-Buck, Janice C.; Jones, Douglas; Frost, Meryll M.; Staab, Edward V.

1997-05-01

One side effect of installing a clinical PACS Is that users become dependent upon the technology and in some cases it can be very difficult to revert back to a film based system if components fail. The nature of system failures range from slow deterioration of function as seen in the loss of monitor luminance through sudden catastrophic loss of the entire PACS networks. This paper describes the quality control procedures in place at the University of Florida and the automatic notification system that alerts PACS personnel when a failure has happened or is anticipated. The goal is to recover from a failure with a minimum of downtime and no data loss. Routine quality control is practiced on all aspects of PACS, from acquisition, through network routing, through display, and including archiving. Whenever possible, the system components perform self and between platform checks for active processes, file system status, errors in log files, and system uptime. When an error is detected or a exception occurs, an automatic page is sent to a pager with a diagnostic code. Documentation on each code, trouble shooting procedures, and repairs are kept on an intranet server accessible only to people involved in maintaining the PACS. In addition to the automatic paging system for error conditions, acquisition is assured by an automatic fax report sent on a daily basis to all technologists acquiring PACS images to be used as a cross check that all studies are archived prior to being removed from the acquisition systems. Daily quality control is preformed to assure that studies can be moved from each acquisition and contrast adjustment. The results of selected quality control reports will be presented. The intranet documentation server will be described with the automatic pager system. Monitor quality control reports will be described and the cost of quality control will be quantified. As PACS is accepted as a clinical tool, the same standards of quality control must be established

SPS attitude control and stationkeeping: Requirements and tradeoffs

NASA Technical Reports Server (NTRS)

Oglevie, R. E.

1980-01-01

The dominant control requirements of solar power satellites change appreciably relative to small contemporary spacecraft. Trade studies and analyses illustrated preferred control approaches. It was found that the geosynchronous equatorial orbit is preferred over the alternative orbits considered, that the solar pressure orbit perturbation dominates stationkeeping propulsion requirements and that a combined AC and SK system using ion electric propulsion can satisfy the attitude control requirements. It was also found that control system/structural dynamic interaction stability can be obtained through frequency separation with reasonable structural dynamic requirements and simplify spacecraft design.

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

PubMed

Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

2017-07-01

The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Analytical approaches to quality assurance and quality control in rangeland monitoring data

USDA-ARS?s Scientific Manuscript database

Producing quality data to support land management decisions is the goal of every rangeland monitoring program. However, the results of quality assurance (QA) and quality control (QC) efforts to improve data quality are rarely reported. The purpose of QA and QC is to prevent and describe non-sampling...

Professional Development for Water Quality Control Personnel.

ERIC Educational Resources Information Center

Shepard, Clinton Lewis

This study investigated the availability of professional development opportunities for water quality control personnel in the midwest. The major objective of the study was to establish a listing of educational opportunities for the professional development of water quality control personnel and to compare these with the opportunities technicians…

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

Ride quality sensitivity to SAS control law and to handling quality variations

NASA Technical Reports Server (NTRS)

Roberts, P. A.; Schmidt, D. K.; Swaim, R. L.

1976-01-01

The RQ trends which large flexible aircraft exhibit under various parameterizations of control laws and handling qualities are discussed. A summary of the assumptions and solution technique, a control law parameterization review, a discussion of ride sensitivity to handling qualities, and the RQ effects generated by implementing relaxed static stability configurations are included.

14 CFR 21.147 - Changes in quality control system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

14 CFR 21.147 - Changes in quality control system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

Colorado Air Quality Control Regulations and Ambient Air Quality Standards.

ERIC Educational Resources Information Center

Colorado State Dept. of Health, Denver. Div. of Air Pollution Control.

Regulations and standards relative to air quality control in Colorado are defined in this publication. Presented first are definitions of terms, a statement of intent, and general provisions applicable to all emission control regulations adopted by the Colorado Air Pollution Control Commission. Following this, three regulations are enumerated: (1)…

Quality Control Technician Curriculum. An Elusive Butterfly.

ERIC Educational Resources Information Center

Holler, Michael

Defining and developing a quality control technician curriculum for an associate degree program is a difficult and puzzling job. There are as many definitions of quality control and curriculum ideas as there are educators asked. However, one could start by dividing the field into its major areas--heavy manufacturing, maintenance, research, and…

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

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

MULKEY, C.H.

1999-07-02

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

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.

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

Multileaf collimator performance monitoring and improvement using semiautomated quality control testing and statistical process control.

PubMed

Létourneau, Daniel; Wang, An; Amin, Md Nurul; Pearce, Jim; McNiven, Andrea; Keller, Harald; Norrlinger, Bernhard; Jaffray, David A

2014-12-01

High-quality radiation therapy using highly conformal dose distributions and image-guided techniques requires optimum machine delivery performance. In this work, a monitoring system for multileaf collimator (MLC) performance, integrating semiautomated MLC quality control (QC) tests and statistical process control tools, was developed. The MLC performance monitoring system was used for almost a year on two commercially available MLC models. Control charts were used to establish MLC performance and assess test frequency required to achieve a given level of performance. MLC-related interlocks and servicing events were recorded during the monitoring period and were investigated as indicators of MLC performance variations. The QC test developed as part of the MLC performance monitoring system uses 2D megavoltage images (acquired using an electronic portal imaging device) of 23 fields to determine the location of the leaves with respect to the radiation isocenter. The precision of the MLC performance monitoring QC test and the MLC itself was assessed by detecting the MLC leaf positions on 127 megavoltage images of a static field. After initial calibration, the MLC performance monitoring QC test was performed 3-4 times/week over a period of 10-11 months to monitor positional accuracy of individual leaves for two different MLC models. Analysis of test results was performed using individuals control charts per leaf with control limits computed based on the measurements as well as two sets of specifications of ± 0.5 and ± 1 mm. Out-of-specification and out-of-control leaves were automatically flagged by the monitoring system and reviewed monthly by physicists. MLC-related interlocks reported by the linear accelerator and servicing events were recorded to help identify potential causes of nonrandom MLC leaf positioning variations. The precision of the MLC performance monitoring QC test and the MLC itself was within ± 0.22 mm for most MLC leaves and the majority of the

Multileaf collimator performance monitoring and improvement using semiautomated quality control testing and statistical process control

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

Létourneau, Daniel, E-mail: daniel.letourneau@rmp.uh.on.ca; McNiven, Andrea; Keller, Harald

2014-12-15

Purpose: High-quality radiation therapy using highly conformal dose distributions and image-guided techniques requires optimum machine delivery performance. In this work, a monitoring system for multileaf collimator (MLC) performance, integrating semiautomated MLC quality control (QC) tests and statistical process control tools, was developed. The MLC performance monitoring system was used for almost a year on two commercially available MLC models. Control charts were used to establish MLC performance and assess test frequency required to achieve a given level of performance. MLC-related interlocks and servicing events were recorded during the monitoring period and were investigated as indicators of MLC performance variations. Methods:more » The QC test developed as part of the MLC performance monitoring system uses 2D megavoltage images (acquired using an electronic portal imaging device) of 23 fields to determine the location of the leaves with respect to the radiation isocenter. The precision of the MLC performance monitoring QC test and the MLC itself was assessed by detecting the MLC leaf positions on 127 megavoltage images of a static field. After initial calibration, the MLC performance monitoring QC test was performed 3–4 times/week over a period of 10–11 months to monitor positional accuracy of individual leaves for two different MLC models. Analysis of test results was performed using individuals control charts per leaf with control limits computed based on the measurements as well as two sets of specifications of ±0.5 and ±1 mm. Out-of-specification and out-of-control leaves were automatically flagged by the monitoring system and reviewed monthly by physicists. MLC-related interlocks reported by the linear accelerator and servicing events were recorded to help identify potential causes of nonrandom MLC leaf positioning variations. Results: The precision of the MLC performance monitoring QC test and the MLC itself was within ±0.22 mm for most MLC

40 CFR 1700.4 - Discharges requiring control.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Discharges requiring control. 1700.4 Section 1700.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY AND DEPARTMENT OF DEFENSE... FOR VESSELS OF THE ARMED FORCES Discharge Determinations § 1700.4 Discharges requiring control. For...

40 CFR 1700.4 - Discharges requiring control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 33 2011-07-01 2011-07-01 false Discharges requiring control. 1700.4 Section 1700.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY AND DEPARTMENT OF DEFENSE... FOR VESSELS OF THE ARMED FORCES Discharge Determinations § 1700.4 Discharges requiring control. For...

40 CFR 1700.4 - Discharges requiring control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Discharges requiring control. 1700.4 Section 1700.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY AND DEPARTMENT OF DEFENSE... FOR VESSELS OF THE ARMED FORCES Discharge Determinations § 1700.4 Discharges requiring control. For...

40 CFR 1700.4 - Discharges requiring control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Discharges requiring control. 1700.4 Section 1700.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY AND DEPARTMENT OF DEFENSE... FOR VESSELS OF THE ARMED FORCES Discharge Determinations § 1700.4 Discharges requiring control. For...

40 CFR 1700.4 - Discharges requiring control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Discharges requiring control. 1700.4 Section 1700.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY AND DEPARTMENT OF DEFENSE... FOR VESSELS OF THE ARMED FORCES Discharge Determinations § 1700.4 Discharges requiring control. For...

Control of Antimicrobial Resistance Requires an Ethical Approach

PubMed Central

Parsonage, Ben; Hagglund, Philip K.; Keogh, Lloyd; Wheelhouse, Nick; Brown, Richard E.; Dancer, Stephanie J.

2017-01-01

Ethical behavior encompasses actions that benefit both self and society. This means that tackling antimicrobial resistance (AMR) becomes an ethical obligation, because the prospect of declining anti-infectives affects everyone. Without preventive action, loss of drugs that have saved lives over the past century, will condemn ourselves, people we know, and people we don’t know, to unacceptable risk of untreatable infection. Policies aimed at extending antimicrobial life should be considered within an ethical framework, in order to balance the choice, range, and quality of drugs against stewardship activities. Conserving availability and effectiveness for future use should not compromise today’s patients. Practices such as antimicrobial prophylaxis for healthy people ‘at risk’ should receive full debate. There are additional ethical considerations for AMR involving veterinary care, agriculture, and relevant bio-industries. Restrictions for farmers potentially threaten the quality and quantity of food production with economic consequences. Antibiotics for companion animals do not necessarily spare those used for humans. While low-income countries cannot afford much-needed drugs, pharmaceutical companies are reluctant to develop novel agents for short-term return only. Public demand encourages over-the-counter, internet, black market, and counterfeit drugs, all of which compromise international control. Prescribers themselves require educational support to balance therapeutic choice against collateral damage to both body and environment. Predicted mortality due to AMR provides justification for international co-operation, commitment and investment to support surveillance and stewardship along with development of novel antimicrobial drugs. Ethical arguments for, and against, control of antimicrobial resistance strategies are presented and discussed in this review. PMID:29163414

Continuous integration and quality control for scientific software

NASA Astrophysics Data System (ADS)

Neidhardt, A.; Ettl, M.; Brisken, W.; Dassing, R.

2013-08-01

Modern software has to be stable, portable, fast and reliable. This is going to be also more and more important for scientific software. But this requires a sophisticated way to inspect, check and evaluate the quality of source code with a suitable, automated infrastructure. A centralized server with a software repository and a version control system is one essential part, to manage the code basis and to control the different development versions. While each project can be compiled separately, the whole code basis can also be compiled with one central “Makefile”. This is used to create automated, nightly builds. Additionally all sources are inspected automatically with static code analysis and inspection tools, which check well-none error situations, memory and resource leaks, performance issues, or style issues. In combination with an automatic documentation generator it is possible to create the developer documentation directly from the code and the inline comments. All reports and generated information are presented as HTML page on a Web server. Because this environment increased the stability and quality of the software of the Geodetic Observatory Wettzell tremendously, it is now also available for scientific communities. One regular customer is already the developer group of the DiFX software correlator project.

A multiple objective optimization approach to quality control

NASA Technical Reports Server (NTRS)

Seaman, Christopher Michael

1991-01-01

The use of product quality as the performance criteria for manufacturing system control is explored. The goal in manufacturing, for economic reasons, is to optimize product quality. The problem is that since quality is a rather nebulous product characteristic, there is seldom an analytic function that can be used as a measure. Therefore standard control approaches, such as optimal control, cannot readily be applied. A second problem with optimizing product quality is that it is typically measured along many dimensions: there are many apsects of quality which must be optimized simultaneously. Very often these different aspects are incommensurate and competing. The concept of optimality must now include accepting tradeoffs among the different quality characteristics. These problems are addressed using multiple objective optimization. It is shown that the quality control problem can be defined as a multiple objective optimization problem. A controller structure is defined using this as the basis. Then, an algorithm is presented which can be used by an operator to interactively find the best operating point. Essentially, the algorithm uses process data to provide the operator with two pieces of information: (1) if it is possible to simultaneously improve all quality criteria, then determine what changes to the process input or controller parameters should be made to do this; and (2) if it is not possible to improve all criteria, and the current operating point is not a desirable one, select a criteria in which a tradeoff should be made, and make input changes to improve all other criteria. The process is not operating at an optimal point in any sense if no tradeoff has to be made to move to a new operating point. This algorithm ensures that operating points are optimal in some sense and provides the operator with information about tradeoffs when seeking the best operating point. The multiobjective algorithm was implemented in two different injection molding scenarios

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

21 CFR 640.56 - Quality control test for potency.

Code of Federal Regulations, 2010 CFR

2010-04-01

... quality control test for potency may be performed by a clinical laboratory which meets the standards of... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Quality control test for potency. 640.56 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.56 Quality control...

Web quality control for lectures: Supercourse and Amazon.com.

PubMed

Linkov, Faina; LaPorte, Ronald; Lovalekar, Mita; Dodani, Sunita

2005-12-01

Peer review has been at the corner stone of quality control of the biomedical journals in the past 300 years. With the emergency of the Internet, new models of quality control and peer review are emerging. However, such models are poorly investigated. We would argue that the popular system of quality control used in Amazon.com offers a way to ensure continuous quality improvement in the area of research communications on the Internet. Such system is providing an interesting alternative to the traditional peer review approaches used in the biomedical journals and challenges the traditional paradigms of scientific publishing. This idea is being explored in the context of Supercourse, a library of 2,350 prevention lectures, shared for free by faculty members from over 150 countries. Supercourse is successfully utilizing quality control approaches that are similar to Amazon.com model. Clearly, the existing approaches and emerging alternatives for quality control in scientific communications needs to be assessed scientifically. Rapid explosion of internet technologies could be leveraged to produce better, more cost effective systems for quality control in the biomedical publications and across all sciences.

40 CFR 81.107 - Greenwood Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.107 Greenwood Intrastate Air Quality Control Region. The Greenwood Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Greenwood Intrastate Air Quality...

40 CFR 81.108 - Columbia Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.108 Columbia Intrastate Air Quality Control Region. The Columbia Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Columbia Intrastate Air Quality...

40 CFR 81.108 - Columbia Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.108 Columbia Intrastate Air Quality Control Region. The Columbia Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Columbia Intrastate Air Quality...

40 CFR 81.111 - Georgetown Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.111 Georgetown Intrastate Air Quality Control Region. The Georgetown Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Georgetown Intrastate Air Quality...

40 CFR 81.109 - Florence Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.109 Florence Intrastate Air Quality Control Region. The Florence Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Florence Intrastate Air Quality...

40 CFR 81.111 - Georgetown Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Regions § 81.111 Georgetown Intrastate Air Quality Control Region. The Georgetown Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Georgetown Intrastate Air Quality...

40 CFR 81.109 - Florence Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.109 Florence Intrastate Air Quality Control Region. The Florence Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Florence Intrastate Air Quality...

40 CFR 81.107 - Greenwood Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Regions § 81.107 Greenwood Intrastate Air Quality Control Region. The Greenwood Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Greenwood Intrastate Air Quality...

Contractor Performed Quality Control on KyTC Projects.

DOT National Transportation Integrated Search

2002-08-01

This report addresses issues related to transferring the responsibility for quality control from the Kentucky Transportation Cabinet (KyTC) to construction contractors. : Several key topics related to Contractor Performed Quality Control (CPQC) are p...

40 CFR 63.1281 - Control equipment requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements for sources except small glycol dehydration units. Owners and operators of small glycol dehydration units shall comply with the control requirements in paragraph (f) of this section. (1) The control... or operator shall determine glycol dehydration unit baseline operations (as defined in § 63.1271...

40 CFR 63.1281 - Control equipment requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements for sources except small glycol dehydration units. Owners and operators of small glycol dehydration units shall comply with the control requirements in paragraph (f) of this section. (1) The control... or operator shall determine glycol dehydration unit baseline operations (as defined in § 63.1271...

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Reference H Cycle 3 Stability, Control, and Flying Qualities Batch Assessments

NASA Technical Reports Server (NTRS)

Henderson, Dennis K.

1999-01-01

This work is an update of the assessment completed in February of 1996, when a preliminary assessment report was issued for the Cycle 2B simulation model. The primary purpose of the final assessment was to re-evaluate each assessment against the flight control system (FCS) requirements document using the updated model. Only a limited number of final assessments were completed due to the close proximity of the release of the Langley model and the assessment deliverable date. The assessment used the nonlinear Cycle 3 simulation model because it combines nonlinear aeroelastic (quasi-static) aerodynamic with hinge moment and rate limited control surface deflections. Both Configuration Aerodynamics (Task 32) and Flight Controls (Task 36) were funded in 1996 to conduct the final stability and control assessments of the unaugmented Reference H configuration in FY96. Because the two tasks had similar output requirements, the work was divided such that Flight Controls would be responsible for the implementation and checkout of the simulation model and Configuration Aerodynamics for writing Madab "script' files, conducting the batch assessments and writing the assessment report. Additionally, Flight Controls was to investigate control surface allocations schemes different from the baseline Reference H in an effort to fulfill flying qualities criteria.

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

PubMed

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

2017-08-07

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

21 CFR 862.1660 - Quality control material (assayed and unassayed).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control material (assayed and unassayed... Test Systems § 862.1660 Quality control material (assayed and unassayed). (a) Identification. A quality... that may arise from reagent or analytical instrument variation. A quality control material (assayed and...

[Quality control criteria in the surgical management of advanced ovarian cancers].

PubMed

Querleu, D; Narducci, F

2009-12-01

Two concurrent policies can be proposed to improve the quality of care for ovarian cancer surgery: organization of care, audit. The two policies are not to be opposed: the efficacy of any policy must be audited, targets are more rapidly reached and more easily audited when an underlying organization is available. However, the arbitrary definition of criteria is a challenge. The interpretation of results depends on the context of each individual center. There is a definite risk of unwanted effects: competition to reach the cut-off if quantitative caseload criteria are demanded, reduction of the quality of cytoreduction if the complication rate is included, selection of patients if the rate of complete cytoreduction is chosen as a major parameter. Quality control must encompass the standard of preoperative workup, the quality of operative report, the complication rate and the oncological outcome. Although quantitative yearly caseload requirements may contribute to the quality of care, it seems more pertinent to recall the prerequisites that the surgeon must fulfil before undertaking a surgery for ovarian cancer. Knowledge of the specific features of the disease and of all the components of its medical management, skills in general surgical procedures required to complete staging and cytoreduction, and contribution to a multidisciplinary team involved in clinical research are mandatory. Even though no definitive proof is available, the available information tend to show a superiority of the standard of surgical care provided by experienced or specialized surgeons.

QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES. Project Summary

EPA Science Inventory

It is generally agreed that both quality assurance (QA) and quality control (QC) are essential to the proper installation and eventual performance of environmentally safe and secure waste containment systems. Even further, there are both manufacturing and construction aspects to...

Air quality benefits of universal particle filter and NOx controls on diesel trucks

NASA Astrophysics Data System (ADS)

Tao, L.; Mcdonald, B. C.; Harley, R.

2015-12-01

Heavy-duty diesel trucks are a major source of black carbon/particulate matter and nitrogen oxide emissions on urban and regional scales. These emissions are relevant to both air quality and climate change. Since 2010 in the US, new engines are required to be equipped with emission control systems that greatly reduce both PM and NOx emissions, by ~98% relative to 1988 levels. To reduce emissions from the legacy fleet of older trucks that still remain on the road, regulations have been adopted in Califonia to accelerate the replacement of older trucks and thereby reduce associated emissions of PM and NOx. Use of diesel particle filters will be widespread by 2016, and universal use of catalytic converters for NOx control is required by 2023. We assess the air quality consequences of this clean-up effort in Southern California, using the Community Multiscale Air Quality model (CMAQ), and comparing three scenarios: historical (2005), present day (2016), and future year (2023). Emissions from the motor vehicle sector are mapped at high spatial resolution based on traffic count and fuel sales data. NOx emissions from diesel engines in 2023 are expected to decrease by ~80% compared to 2005, while the fraction of NOx emitted as NO2 is expected to increase from 5 to 18%. Air quality model simulations will be analyzed to quantify changes in NO2, black carbon, particulate matter, and ozone, both basin-wide and near hot spots such as ports and major highways.

Antimisting kerosene: Base fuel effects, blending and quality control techniques

NASA Technical Reports Server (NTRS)

Yavrouian, A. H.; Ernest, J.; Sarohia, V.

1984-01-01

The problems associated with blending of the AMK additive with Jet A, and the base fuel effects on AMK properties are addressed. The results from the evaluation of some of the quality control techniques for AMK are presented. The principal conclusions of this investigation are: significant compositional differences for base fuel (Jet A) within the ASTM specification DI655; higher aromatic content of the base fuel was found to be beneficial for the polymer dissolution at ambient (20 C) temperature; using static mixer technology, the antimisting additive (FM-9) is in-line blended with Jet A, producing AMK which has adequate fire-protection properties 15 to 20 minutes after blending; degradability of freshly blended and equilibrated AMK indicated that maximum degradability is reached after adequate fire protection is obtained; the results of AMK degradability as measured by filter ratio, confirmed previous RAE data that power requirements to decade freshly blended AMK are significantly higher than equilibrated AMK; blending of the additive by using FM-9 concentrate in Jet A produces equilibrated AMK almost instantly; nephelometry offers a simple continuous monitoring capability and is used as a real time quality control device for AMK; and trajectory (jet thurst) and pressure drop tests are useful laboratory techniques for evaluating AMK quality.

Helicopter mathematical models and control law development for handling qualities research

NASA Technical Reports Server (NTRS)

Chen, Robert T. N.; Lebacqz, J. Victor; Aiken, Edwin W.; Tischler, Mark B.

1988-01-01

Progress made in joint NASA/Army research concerning rotorcraft flight-dynamics modeling, design methodologies for rotorcraft flight-control laws, and rotorcraft parameter identification is reviewed. Research into these interactive disciplines is needed to develop the analytical tools necessary to conduct flying qualities investigations using both the ground-based and in-flight simulators, and to permit an efficient means of performing flight test evaluation of rotorcraft flying qualities for specification compliance. The need for the research is particularly acute for rotorcraft because of their mathematical complexity, high order dynamic characteristics, and demanding mission requirements. The research in rotorcraft flight-dynamics modeling is pursued along two general directions: generic nonlinear models and nonlinear models for specific rotorcraft. In addition, linear models are generated that extend their utilization from 1-g flight to high-g maneuvers and expand their frequency range of validity for the design analysis of high-gain flight control systems. A variety of methods ranging from classical frequency-domain approaches to modern time-domain control methodology that are used in the design of rotorcraft flight control laws is reviewed. Also reviewed is a study conducted to investigate the design details associated with high-gain, digital flight control systems for combat rotorcraft. Parameter identification techniques developed for rotorcraft applications are reviewed.

Telerobot operator control station requirements

NASA Technical Reports Server (NTRS)

Kan, Edwin P.

1988-01-01

The operator control station of a telerobot system has unique functional and human factors requirements. It has to satisfy the needs of a truly interactive and user-friendly complex system, a telerobot system being a hybrid between a teleoperated and an autonomous system. These functional, hardware and software requirements are discussed, with explicit reference to the design objectives and constraints of the JPL/NASA Telerobot Demonstrator System.

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.

Tracing And Control Of Engineering Requirements

NASA Technical Reports Server (NTRS)

Turner, Philip R.; Stoller, Richard L.; Neville, Ted; Boyle, Karen A.

1991-01-01

TRACER (Tracing and Control of Engineering Requirements) is data-base/word-processing software system created to document and maintain order of both requirements and descriptions associated with engineering project. Implemented on IBM PC under PC-DOS. Written with CLIPPER.

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...

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.

Multi-Agent Architecture with Support to Quality of Service and Quality of Control

NASA Astrophysics Data System (ADS)

Poza-Luján, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, Jose-Enrique

Multi Agent Systems (MAS) are one of the most suitable frameworks for the implementation of intelligent distributed control system. Agents provide suitable flexibility to give support to implied heterogeneity in cyber-physical systems. Quality of Service (QoS) and Quality of Control (QoC) parameters are commonly utilized to evaluate the efficiency of the communications and the control loop. Agents can use the quality measures to take a wide range of decisions, like suitable placement on the control node or to change the workload to save energy. This article describes the architecture of a multi agent system that provides support to QoS and QoC parameters to optimize de system. The architecture uses a Publish-Subscriber model, based on Data Distribution Service (DDS) to send the control messages. Due to the nature of the Publish-Subscribe model, the architecture is suitable to implement event-based control (EBC) systems. The architecture has been called FSACtrl.

40 CFR 81.87 - Metropolitan Boise Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.87 Section 81.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.87 Metropolitan Boise Intrastate Air Quality Control Region. The Metropolitan Boise Intrastate Air Quality Control Region (Idaho) consists of the territorial area encompassed...

40 CFR 81.89 - Metropolitan Cheyenne Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.89 Section 81.89 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.89 Metropolitan Cheyenne Intrastate Air Quality Control Region. The Metropolitan Cheyenne Intrastate Air Quality Control Region (Wyoming) consists of the territorial area...

40 CFR 81.101 - Metropolitan Dubuque Interstate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.101 Section 81.101 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.101 Metropolitan Dubuque Interstate Air Quality Control Region. The Metropolitan Dubuque Interstate Air Quality Control Region (Illinois-Iowa-Wisconsin) consists of the...

40 CFR 81.104 - Central Pennsylvania Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.104 Section 81.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.104 Central Pennsylvania Intrastate Air Quality Control Region. The Central Pennsylvania Intrastate Air Quality Control Region consists of the territorial area encompassed by...

40 CFR 81.106 - Greenville-Spartanburg Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.106 Section 81.106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.106 Greenville-Spartanburg Intrastate Air Quality Control Region. The Greenville-Spartanburg Intrastate Air Quality Control Region (South Carolina) consists of the territorial...

40 CFR 81.120 - Middle Tennessee Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.120 Section 81.120 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.120 Middle Tennessee Intrastate Air Quality Control Region. The Middle Tennessee Intrastate Air Quality Control Region consists of the territorial area encompassed by...

40 CFR 81.75 - Metropolitan Charlotte Interstate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.75 Section 81.75 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.75 Metropolitan Charlotte Interstate Air Quality Control Region. The Metropolitan Charlotte Interstate Air Quality Control Region (North Carolina-South Carolina) has been revised...

40 CFR 81.79 - Northeastern Oklahoma Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.79 Section 81.79 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.79 Northeastern Oklahoma Intrastate Air Quality Control Region. The Metropolitan Tulsa Intrastate Air Quality Control Region has been renamed the Northeastern Oklahoma Intrastate...

40 CFR 81.119 - Western Tennessee Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.119 Section 81.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.119 Western Tennessee Intrastate Air Quality Control Region. The Western Tennessee Intrastate Air Quality Control Region consists of the territorial area encompassed by...

40 CFR 81.104 - Central Pennsylvania Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.104 Section 81.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.104 Central Pennsylvania Intrastate Air Quality Control Region. The Central Pennsylvania Intrastate Air Quality Control Region consists of the territorial area encompassed by...

40 CFR 81.87 - Metropolitan Boise Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.87 Section 81.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.87 Metropolitan Boise Intrastate Air Quality Control Region. The Metropolitan Boise Intrastate Air Quality Control Region (Idaho) consists of the territorial area encompassed...

40 CFR 81.79 - Northeastern Oklahoma Intrastate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.79 Section 81.79 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.79 Northeastern Oklahoma Intrastate Air Quality Control Region. The Metropolitan Tulsa Intrastate Air Quality Control Region has been renamed the Northeastern Oklahoma Intrastate...

40 CFR 81.101 - Metropolitan Dubuque Interstate Air Quality Control Region.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Quality Control Region. 81.101 Section 81.101 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.101 Metropolitan Dubuque Interstate Air Quality Control Region. The Metropolitan Dubuque Interstate Air Quality Control Region (Illinois-Iowa-Wisconsin) consists of the...

40 CFR 81.106 - Greenville-Spartanburg Intrastate Air Quality Control Region.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Region. 81.106 Section 81.106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Air Quality Control Regions § 81.106 Greenville-Spartanburg Intrastate Air Quality Control Region. The Greenville-Spartanburg Intrastate Air Quality Control Region (South Carolina) consists of the territorial...

40 CFR 81.89 - Metropolitan Cheyenne Intrastate Air Quality Control Region.