Bootstrap Signal-to-Noise Confidence Intervals: An Objective Method for Subject Exclusion and Quality Control in ERP Studies

PubMed Central

Parks, Nathan A.; Gannon, Matthew A.; Long, Stephanie M.; Young, Madeleine E.

2016-01-01

Analysis of event-related potential (ERP) data includes several steps to ensure that ERPs meet an appropriate level of signal quality. One such step, subject exclusion, rejects subject data if ERP waveforms fail to meet an appropriate level of signal quality. Subject exclusion is an important quality control step in the ERP analysis pipeline as it ensures that statistical inference is based only upon those subjects exhibiting clear evoked brain responses. This critical quality control step is most often performed simply through visual inspection of subject-level ERPs by investigators. Such an approach is qualitative, subjective, and susceptible to investigator bias, as there are no standards as to what constitutes an ERP of sufficient signal quality. Here, we describe a standardized and objective method for quantifying waveform quality in individual subjects and establishing criteria for subject exclusion. The approach uses bootstrap resampling of ERP waveforms (from a pool of all available trials) to compute a signal-to-noise ratio confidence interval (SNR-CI) for individual subject waveforms. The lower bound of this SNR-CI (SNRLB) yields an effective and objective measure of signal quality as it ensures that ERP waveforms statistically exceed a desired signal-to-noise criterion. SNRLB provides a quantifiable metric of individual subject ERP quality and eliminates the need for subjective evaluation of waveform quality by the investigator. We detail the SNR-CI methodology, establish the efficacy of employing this approach with Monte Carlo simulations, and demonstrate its utility in practice when applied to ERP datasets. PMID:26903849

Automatic-Control System for Safer Brazing

NASA Technical Reports Server (NTRS)

Stein, J. A.; Vanasse, M. A.

1986-01-01

Automatic-control system for radio-frequency (RF) induction brazing of metal tubing reduces probability of operator errors, increases safety, and ensures high-quality brazed joints. Unit combines functions of gas control and electric-power control. Minimizes unnecessary flow of argon gas into work area and prevents electrical shocks from RF terminals. Controller will not allow power to flow from RF generator to brazing head unless work has been firmly attached to head and has actuated micro-switch. Potential shock hazard eliminated. Flow of argon for purging and cooling must be turned on and adjusted before brazing power applied. Provision ensures power not applied prematurely, causing damaged work or poor-quality joints. Controller automatically turns off argon flow at conclusion of brazing so potentially suffocating gas does not accumulate in confined areas.

48 CFR 1646.201 - Contract Quality Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

42 CFR 493.1445 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic... result is found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

On-line welding quality inspection system for steel pipe based on machine vision

NASA Astrophysics Data System (ADS)

Yang, Yang

2017-05-01

In recent years, high frequency welding has been widely used in production because of its advantages of simplicity, reliability and high quality. In the production process, how to effectively control the weld penetration welding, ensure full penetration, weld uniform, so as to ensure the welding quality is to solve the problem of the present stage, it is an important research field in the field of welding technology. In this paper, based on the study of some methods of welding inspection, a set of on-line welding quality inspection system based on machine vision is designed.

28 CFR 104.71 - Procedures to prevent and detect fraud.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 104.71 Section 104.71 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) SEPTEMBER 11TH VICTIM... prevent and detect fraud. (a) Review of claims. For the purpose of detecting and preventing the payment of...; and (3) Ensure the quality control of claims review procedures. (b) Quality control. The Special...

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...

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

DTIC Science & Technology

1997-06-30

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

42 CFR 493.1407 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... developed and used for each of the tests performed in the laboratory provide quality laboratory services for... results are found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

GEOSPATIAL QA

EPA Science Inventory

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

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

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

DTIC Science & Technology

1997-06-11

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

Developing and implementing a computerized nursing quality control system in a tertiary general medical center in Israel.

PubMed

Kagan, Ilya; Cohen, Rachel; Fish, Miri; Mezare, Henia Perry

2014-01-01

This article describes the development and implementation of the Nursing Quality Indicators Scale and a quality control system for hospital nursing care, which allows universal access to all external and internal audit results, thus ensuring complete data transparency. Standardized indicators make departments' performance comparable. Key to the new system is nurses' self-audit and responsibility for making quality improvements at the ward level.

Ensuring Quality in AFRINEST and SATT

PubMed Central

2013-01-01

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

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.

Managing Air Quality - Program Implementation

EPA Pesticide Factsheets

Describes elements for the set of activities to ensure that control strategies are put into effect and that air quality goals and standards are fulfilled, permitting programs, and additional resources related to implementation under the Clean Air Act.

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

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...

[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.

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

Bel Marin Keys Unit V Expansion of the Hamilton Wetland Restoration Project. Volume 3. Responses to Comments, Final Supplemental Environmental Impact Report/Environmental Impact Statement

DTIC Science & Technology

2003-04-01

include a program for implementing new development and construction site storm water quality controls. The objective of this component is to ensure...impacts (see Storm Water Quality Control, below). The Regional Board has adopted U.S. EPA’s Clean Water Act Section 404(b)(1) "Guidelines for...other Waters of the State. Storm Water Quality Control Storm water is the major source of fresh water to creeks and waterways. Storm water quality is

QA/QC in the laboratory

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

QA/QC in the laboratory. Session F

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

MO-A-16A-01: QA Procedures and Metrics: In Search of QA Usability

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

Sathiaseelan, V; Thomadsen, B

Radiation therapy has undergone considerable changes in the past two decades with a surge of new technology and treatment delivery methods. The complexity of radiation therapy treatments has increased and there has been increased awareness and publicity about the associated risks. In response, there has been proliferation of guidelines for medical physicists to adopt to ensure that treatments are delivered safely. Task Group recommendations are copious, and clinical physicists' hours are longer, stretched to various degrees between site planning and management, IT support, physics QA, and treatment planning responsibilities.Radiation oncology has many quality control practices in place to ensure themore » delivery of high-quality, safe treatments. Incident reporting systems have been developed to collect statistics about near miss events at many radiation oncology centers. However, tools are lacking to assess the impact of these various control measures. A recent effort to address this shortcoming is the work of Ford et al (2012) who recently published a methodology enumerating quality control quantification for measuring the effectiveness of safety barriers. Over 4000 near-miss incidents reported from 2 academic radiation oncology clinics were analyzed using quality control quantification, and a profile of the most effective quality control measures (metrics) was identified.There is a critical need to identify a QA metric to help the busy clinical physicists to focus their limited time and resources most effectively in order to minimize or eliminate errors in the radiation treatment delivery processes. In this symposium the usefulness of workflows and QA metrics to assure safe and high quality patient care will be explored.Two presentations will be given:Quality Metrics and Risk Management with High Risk Radiation Oncology ProceduresStrategies and metrics for quality management in the TG-100 Era Learning Objectives: Provide an overview and the need for QA usability metrics: Different cultures/practices affecting the effectiveness of methods and metrics. Show examples of quality assurance workflows, Statistical process control, that monitor the treatment planning and delivery process to identify errors. To learn to identify and prioritize risks and QA procedures in radiation oncology. Try to answer the question: Can a quality assurance program aided by quality assurance metrics help minimize errors and ensure safe treatment delivery. Should such metrics be institution specific.« less

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Software quality assurance plan for GCS

NASA Technical Reports Server (NTRS)

Duncan, Stephen E.; Bailey, Elizabeth K.

1990-01-01

The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.

49 CFR 179.7 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... means to detect any nonconformity in the manufacturing, repair, inspection, testing, and qualification... quality control personnel. (3) Procedures to ensure that the latest applicable drawings, design calculations, specifications, and instructions are used in manufacture, inspection, testing, and repair. (4...

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.

49 CFR 178.273 - Approval of Specification UN portable tanks.

Code of Federal Regulations, 2013 CFR

2013-10-01

... including, but not limited to, ensuring that the quality control, design calculations and required tests are... necessary to ensure that the design meets the relevant specification. (ii) The manufacturer's serial number that will be assigned to each portable tank. (iii) A statement as to whether the design type has been...

49 CFR 178.273 - Approval of Specification UN portable tanks.

Code of Federal Regulations, 2011 CFR

2011-10-01

... including, but not limited to, ensuring that the quality control, design calculations and required tests are... necessary to ensure that the design meets the relevant specification. (ii) The manufacturer's serial number that will be assigned to each portable tank. (iii) A statement as to whether the design type has been...

49 CFR 178.273 - Approval of Specification UN portable tanks.

Code of Federal Regulations, 2012 CFR

2012-10-01

... including, but not limited to, ensuring that the quality control, design calculations and required tests are... necessary to ensure that the design meets the relevant specification. (ii) The manufacturer's serial number that will be assigned to each portable tank. (iii) A statement as to whether the design type has been...

49 CFR 178.273 - Approval of Specification UN portable tanks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... including, but not limited to, ensuring that the quality control, design calculations and required tests are... necessary to ensure that the design meets the relevant specification. (ii) The manufacturer's serial number that will be assigned to each portable tank. (iii) A statement as to whether the design type has been...

49 CFR 178.273 - Approval of Specification UN portable tanks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... including, but not limited to, ensuring that the quality control, design calculations and required tests are... necessary to ensure that the design meets the relevant specification. (ii) The manufacturer's serial number that will be assigned to each portable tank. (iii) A statement as to whether the design type has been...

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.

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Metrology: Measurement Assurance Program Guidelines

NASA Technical Reports Server (NTRS)

Eicke, W. G.; Riley, J. P.; Riley, K. J.

1995-01-01

The 5300.4 series of NASA Handbooks for Reliability and Quality Assurance Programs have provisions for the establishment and utilization of a documented metrology system to control measurement processes and to provide objective evidence of quality conformance. The intent of these provisions is to assure consistency and conformance to specifications and tolerances of equipment, systems, materials, and processes procured and/or used by NASA, its international partners, contractors, subcontractors, and suppliers. This Measurement Assurance Program (MAP) guideline has the specific objectives to: (1) ensure the quality of measurements made within NASA programs; (2) establish realistic measurement process uncertainties; (3) maintain continuous control over the measurement processes; and (4) ensure measurement compatibility among NASA facilities. The publication addresses MAP methods as applied within and among NASA installations and serves as a guide to: control measurement processes at the local level (one facility); conduct measurement assurance programs in which a number of field installations are joint participants; and conduct measurement integrity (round robin) experiments in which a number of field installations participate to assess the overall quality of particular measurement processes at a point in time.

[Basic considerations during outsourcing of clinical data management services].

PubMed

Shen, Tong; Liu, Yan

2015-11-01

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Quality Assurance Specifications for Planetary Protection Assays

NASA Astrophysics Data System (ADS)

Baker, Amy

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

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

PubMed

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

2015-05-01

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

Oregon Department of Transportation research leader : fall 2008.

DOT National Transportation Integrated Search

2008-01-01

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

Pulse-Flow Microencapsulation System

NASA Technical Reports Server (NTRS)

Morrison, Dennis R.

2006-01-01

The pulse-flow microencapsulation system (PFMS) is an automated system that continuously produces a stream of liquid-filled microcapsules for delivery of therapeutic agents to target tissues. Prior microencapsulation systems have relied on batch processes that involve transfer of batches between different apparatuses for different stages of production followed by sampling for acquisition of quality-control data, including measurements of size. In contrast, the PFMS is a single, microprocessor-controlled system that performs all processing steps, including acquisition of quality-control data. The quality-control data can be used as real-time feedback to ensure the production of large quantities of uniform microcapsules.

Quality Assurance of RNA Expression Profiling in Clinical Laboratories

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L.

2012-01-01

RNA expression profiles are increasingly used to diagnose and classify disease, based on expression patterns of as many as several thousand RNAs. To ensure quality of expression profiling services in clinical settings, a standard operating procedure incorporates multiple quality indicators and controls, beginning with preanalytic specimen preparation and proceeding thorough analysis, interpretation, and reporting. Before testing, histopathological examination of each cellular specimen, along with optional cell enrichment procedures, ensures adequacy of the input tissue. Other tactics include endogenous controls to evaluate adequacy of RNA and exogenous or spiked controls to evaluate run- and patient-specific performance of the test system, respectively. Unique aspects of quality assurance for array-based tests include controls for the pertinent outcome signatures that often supersede controls for each individual analyte, built-in redundancy for critical analytes or biochemical pathways, and software-supported scrutiny of abundant data by a laboratory physician who interprets the findings in a manner facilitating appropriate medical intervention. Access to high-quality reagents, instruments, and software from commercial sources promotes standardization and adoption in clinical settings, once an assay is vetted in validation studies as being analytically sound and clinically useful. Careful attention to the well-honed principles of laboratory medicine, along with guidance from government and professional groups on strategies to preserve RNA and manage large data sets, promotes clinical-grade assay performance. PMID:22020152

The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

Quality assurance: Importance of systems and standard operating procedures

PubMed Central

Manghani, Kishu

2011-01-01

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

Quality assurance: Importance of systems and standard operating procedures.

PubMed

Manghani, Kishu

2011-01-01

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

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

Controlling coarse woody debris inventory quality: taper and relative size methods

Treesearch

C.W. Woodall; J.A. Westfall

2008-01-01

Accurately measuring the dimensions of coarse woody debris (CWD) is critical for ensuring the quality of CWD estimates and, hence, for accurately estimating forest ecosystem attributes (e.g., CWD carbon stocks). To improve the quality of CWD dimensional measurements, the distribution of taper (ratio of change in diameter and length) and relative size (RS; ratio of...

[Physical and technical quality assurance in German breast cancer screening: progress report of the Reference Center Muenster after three years].

PubMed

Sommer, A; Girnus, R; Wendt, B; Czwoydzinski, J; Wüstenbecker, C; Heindel, W; Lenzen, H

2009-05-01

German breast cancer screening is monitored by a large physical quality assurance program. This report refers to the first experiences of the Reference Center (RC) Muenster after three years of the technical quality control of digital and analog mammography units (MU). This paper also shows whether the presently used quality assurance (QA) method is able to ensure that the MUs in the screening program are functioning without any serious problems. RC Muenster supervises 95 units (May 2008). The daily, weekly and monthly quality assurance of these units is controlled by web-based QA software named "MammoConrol" and developed by RC Muenster. The annual QA for the units must be conducted in the form of an on-site inspection by medical physics experts of the RC and is scored by an objective ranking system. The results of these QA routines were evaluated and analyzed for this paper. During the period from 3/1/2006 to 5/31/2008, 8 % of the analog systems and 1 % of the digital systems exhibited problems in the daily QA. For 9 % of the analog MUs and 17 % of the digital MUs, failures appeared in the monthly QA. In the annual control, 86.7 % of the analog units exhibited slight problems and 13.3 % had serious problems. With respect to the digital units, 12 % were without any defects, 58 % had slight problems, 27 % had serious failures and 3 % had to be reported to the responsible authorities and were temporarily shut down. The special quality control requirements for German breast cancer screening, including annual on-site checks of the units, have shown in the last three years that QA with a high monitoring standard can be ensured for a large number of decentralized MUs. The currently used QA method sufficiently ensures that the screening program is technically safe. Further studies must show whether the density and focus of the QA measures must be reconfigured.

Grade Validity of Online Quantitative Courses

ERIC Educational Resources Information Center

Faurer, Judson C.

2013-01-01

Are prospective employers getting "quality" educated, degreed applicants and are academic institutions that offer online degree programs ensuring the quality control of the courses/programs offered? The issue specifically addressed in this paper is not with all institutions offering degrees through online programs or even with all online…

Grade Validity of Online Quantitative Courses

ERIC Educational Resources Information Center

Faurer, Judson C.

2009-01-01

Are prospective employers getting "quality" educated degreed applicants and are academic institutions that offer online degree programs ensuring the quality control of the courses/programs offered? The issue specifically addressed in this paper is not with all institutions offering degrees through online programs or even with all online…

A quality system for PET: An industry perspective

NASA Astrophysics Data System (ADS)

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

2005-12-01

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

An introduction to statistical process control in research proteomics.

PubMed

Bramwell, David

2013-12-16

Statistical process control is a well-established and respected method which provides a general purpose, and consistent framework for monitoring and improving the quality of a process. It is routinely used in many industries where the quality of final products is critical and is often required in clinical diagnostic laboratories [1,2]. To date, the methodology has been little utilised in research proteomics. It has been shown to be capable of delivering quantitative QC procedures for qualitative clinical assays [3] making it an ideal methodology to apply to this area of biological research. To introduce statistical process control as an objective strategy for quality control and show how it could be used to benefit proteomics researchers and enhance the quality of the results they generate. We demonstrate that rules which provide basic quality control are easy to derive and implement and could have a major impact on data quality for many studies. Statistical process control is a powerful tool for investigating and improving proteomics research work-flows. The process of characterising measurement systems and defining control rules forces the exploration of key questions that can lead to significant improvements in performance. This work asserts that QC is essential to proteomics discovery experiments. Every experimenter must know the current capabilities of their measurement system and have an objective means for tracking and ensuring that performance. Proteomic analysis work-flows are complicated and multi-variate. QC is critical for clinical chemistry measurements and huge strides have been made in ensuring the quality and validity of results in clinical biochemistry labs. This work introduces some of these QC concepts and works to bridge their use from single analyte QC to applications in multi-analyte systems. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics. Copyright © 2013 The Author. Published by Elsevier B.V. All rights reserved.

40 CFR 98.284 - Monitoring and QA/QC requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Healthy satellites provide quality service

NASA Astrophysics Data System (ADS)

Margittai, Paul

The procedures used by Telesat Canada to ensure the performance of Anik satellites is described. At the Satellite Telemetry, Tracking and Command station, each Anik satellite has its own dedicated antenna. Telemetered information from the satellites is received, processed and forwarded to the Satellite Control Center. There the satellite controllers issue all commands to the satellites, and continually monitor the telemetered data. These data, describing the state of health of the satellites, are then analyzed by engineering specialists. The satellites are held in their precise orbital positions by means of specially developed software. The Anik C and D satellites employ travelling wave tube amplifiers (TWTAs) in the transpounder channels. The TWTA saturated flux density (SFD) and equivalent isotropic radiated power (EIRP) are regularly measured and their trends scrutinized. This ensures that customers receive the radio frequency power needed for high-quality service. The satellite electrical power is supplied by the solar cell array and batteries. Power system performance is evaluated regularly to ensure that power is available to operate the required number of TWTAs. In addition to rain-fades, short service interruptions can be caused by high voltage trip-offs of TWTAs, and by electrostatic discharge related anomalies. To minimize these interruptions, Telesat ensures that the satellite controllers are fully trained and prepared for any eventuality, and the relevant operational procedures are continually refined. A fully trained staff of satellite controllers keep interruptions caused by high voltage trip-offs of TWTAs and by electrostatic discharge to a minimum.

Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

PubMed

Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

2017-11-01

Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

Outsourcing Photocopying in a Library: One Experience.

ERIC Educational Resources Information Center

Wittorf, Robert

1998-01-01

Describes the process for outsourcing photocopying including developing a clear request for proposal, monitoring and responding to vendor performance, and ensuring quality controls in academic libraries. (Author/PEN)

Deceleration of Fusion–Fission Cycles Improves Mitochondrial Quality Control during Aging

PubMed Central

Meyer-Hermann, Michael; Osiewacz, Heinz D.

2012-01-01

Mitochondrial dynamics and mitophagy play a key role in ensuring mitochondrial quality control. Impairment thereof was proposed to be causative to neurodegenerative diseases, diabetes, and cancer. Accumulation of mitochondrial dysfunction was further linked to aging. Here we applied a probabilistic modeling approach integrating our current knowledge on mitochondrial biology allowing us to simulate mitochondrial function and quality control during aging in silico. We demonstrate that cycles of fusion and fission and mitophagy indeed are essential for ensuring a high average quality of mitochondria, even under conditions in which random molecular damage is present. Prompted by earlier observations that mitochondrial fission itself can cause a partial drop in mitochondrial membrane potential, we tested the consequences of mitochondrial dynamics being harmful on its own. Next to directly impairing mitochondrial function, pre-existing molecular damage may be propagated and enhanced across the mitochondrial population by content mixing. In this situation, such an infection-like phenomenon impairs mitochondrial quality control progressively. However, when imposing an age-dependent deceleration of cycles of fusion and fission, we observe a delay in the loss of average quality of mitochondria. This provides a rational why fusion and fission rates are reduced during aging and why loss of a mitochondrial fission factor can extend life span in fungi. We propose the ‘mitochondrial infectious damage adaptation’ (MIDA) model according to which a deceleration of fusion–fission cycles reflects a systemic adaptation increasing life span. PMID:22761564

48 CFR 970.0370-1 - Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... management and quality control to discourage waste, fraud and abuse; and to ensure that components, products, and services that are provided to the Department of Energy (DOE) satisfy the contractor's obligations... for effective management systems and internal controls within their areas of assigned responsibility...

Modelling and control for laser based welding processes: modern methods of process control to improve quality of laser-based joining methods

NASA Astrophysics Data System (ADS)

Zäh, Ralf-Kilian; Mosbach, Benedikt; Hollwich, Jan; Faupel, Benedikt

2017-02-01

To ensure the competitiveness of manufacturing companies it is indispensable to optimize their manufacturing processes. Slight variations of process parameters and machine settings have only marginally effects on the product quality. Therefore, the largest possible editing window is required. Such parameters are, for example, the movement of the laser beam across the component for the laser keyhole welding. That`s why it is necessary to keep the formation of welding seams within specified limits. Therefore, the quality of laser welding processes is ensured, by using post-process methods, like ultrasonic inspection, or special in-process methods. These in-process systems only achieve a simple evaluation which shows whether the weld seam is acceptable or not. Furthermore, in-process systems use no feedback for changing the control variables such as speed of the laser or adjustment of laser power. In this paper the research group presents current results of the research field of Online Monitoring, Online Controlling and Model predictive controlling in laser welding processes to increase the product quality. To record the characteristics of the welding process, tested online methods are used during the process. Based on the measurement data, a state space model is ascertained, which includes all the control variables of the system. Depending on simulation tools the model predictive controller (MPC) is designed for the model and integrated into an NI-Real-Time-System.

Primary display latency criteria based on flying qualities and performance data

NASA Technical Reports Server (NTRS)

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

1993-01-01

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

Lessons from industry: one school's transformation toward "lean" curricular governance.

PubMed

Stratton, Terry D; Rudy, David W; Sauer, Marlene J; Perman, Jay A; Jennings, C Darrell

2007-04-01

As medical education grapples with organizational calls for centralized curricular oversight, programs may be compelled to respond by establishing highly vertical, stacked governance structures. Although these models offer discrete advantages over the horizontal, compartmentalized structures they are designed to replace, they pose new challenges to ensuring curricular quality and the educational innovations that drive the curricula. The authors describe a hybrid quality-assurance (QA) governance structure introduced in 2003 at the University of Kentucky College of Medicine (UKCOM) that ensures centralized curricular oversight of the educational product while allowing individualized creative control over the educational process. Based on a Lean production model, this approach draws on industry experiences that strategically separate institutional accountability (management) for a quality curriculum from the decision-making processes required to ensure it (production). In so doing, the authors acknowledge general similarities and key differences between overseeing the manufacture of a complex product versus the education of a physician-emphasizing the structured, sequential, and measurable nature of each process. Further, the authors briefly trace the emergence of quality approaches in manufacturing and discuss the philosophical changes that accompany transition to an institutional governance system that relies on vigorous, robust performance measures to offer continuous feedback on curricular quality.

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.

[The comprehensive approach to ensure the quality of forensic medical examination of a cadaver].

PubMed

Mel'nikov, O V; Mal'tsev, A E; Petrov, S B; Petrov, B A

2015-01-01

The objective of the present work was to estimate the effectiveness of the comprehensive monitoring system designed to enhance the quality of forensic medical expertise for determining the cause of death in the hanging cases. It was shown that the practical application of the algorithmization and automated quality control system improves the effectiveness of forensic medical examination of the cadavers in the hanging cases. The system performs the control, directing, and teaching functions. Moreover, it allows to estimate the completeness of the examination of the cadaver.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA/QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of Field Quality Assurance and Quality Control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the "Border" study. Keywords: custody; QA/QC; field checks.

The Nation...

Quality and safety aspects in histopathology laboratory

PubMed Central

Adyanthaya, Soniya; Jose, Maji

2013-01-01

Histopathology is an art of analyzing and interpreting the shapes, sizes and architectural patterns of cells and tissues within a given specific clinical background and a science by which the image is placed in the context of knowledge of pathobiology, to arrive at an accurate diagnosis. To function effectively and safely, all the procedures and activities of histopathology laboratory should be evaluated and monitored accurately. In histopathology laboratory, the concept of quality control is applicable to pre-analytical, analytical and post-analytical activities. Ensuring safety of working personnel as well as environment is also highly important. Safety issues that may come up in a histopathology lab are primarily those related to potentially hazardous chemicals, biohazardous materials, accidents linked to the equipment and instrumentation employed and general risks from electrical and fire hazards. This article discusses quality management system which can ensure quality performance in histopathology laboratory. The hazards in pathology laboratories and practical safety measures aimed at controlling the dangers are also discussed with the objective of promoting safety consciousness and the practice of laboratory safety. PMID:24574660

Radiation protection program for early detection of breast cancer in a mammography facility

NASA Astrophysics Data System (ADS)

Villagomez Casimiro, Mariana; Ruiz Trejo, Cesar; Espejo Fonseca, Ruby

2014-11-01

Mammography is the best tool for early detection of Breast Cancer. In this diagnostic radiology modality it is necessary to establish the criteria to ensure the proper use and operation of the equipment used to obtain mammographic images in order to contribute to the safe use of ionizing radiation. The aim of the work was to implement at FUCAM-AC the radiation protection program which must be established for patients and radiation workers according to Mexican standards [1-4]. To achieve this goal, radiation protection and quality control manuals were elaborated [5]. Furthermore, a quality control program (QCP) in the mammography systems (analog/digital), darkroom included, has been implemented. Daily sensitometry, non-variability of the image quality, visualizing artifacts, revision of the equipment mechanical stability, compression force and analysis of repetition studies are some of the QCP routine tests that must be performed by radiological technicians of this institution as a set of actions to ensure the protection of patients. Image quality and patients dose assessment were performed on 4 analog equipment installed in 2 mobile units. In relation to dose assessment, all equipment passed the acceptance criteria (<3 mGy per projection). The image quality test showed that most images (70%)- presented artifacts. A brief summary of the results of quality control tests applied to the equipment and film processor are presented. To maintain an adequate level of quality and safety at FUCAM-AC is necessary that the proposed radiation protection program in this work is applied.

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

PubMed

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

2016-12-01

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

10 CFR 72.158 - Control of special processes.

Code of Federal Regulations, 2013 CFR

2013-01-01

... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality..., and applicant for a CoC shall establish measures to ensure that special processes, including welding...

10 CFR 72.158 - Control of special processes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality..., and applicant for a CoC shall establish measures to ensure that special processes, including welding...

10 CFR 72.158 - Control of special processes.

Code of Federal Regulations, 2012 CFR

2012-01-01

... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality..., and applicant for a CoC shall establish measures to ensure that special processes, including welding...

10 CFR 72.158 - Control of special processes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality..., and applicant for a CoC shall establish measures to ensure that special processes, including welding...

[Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

PubMed

Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

2011-12-01

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1). Copyright © 2011 Elsevier España S.L. All rights reserved.

Quality controls for wind measurement of a 1290-MHz boundary layer profiler under strong wind conditions.

PubMed

Liu, Zhao; Zheng, Chaorong; Wu, Yue

2017-09-01

Wind profilers have been widely adopted to observe the wind field information in the atmosphere for different purposes. But accuracy of its observation has limitations due to various noises or disturbances and hence need to be further improved. In this paper, the data measured under strong wind conditions, using a 1290-MHz boundary layer profiler (BLP), are quality controlled via a composite quality control (QC) procedure proposed by the authors. Then, through the comparison with the data measured by radiosonde flights (balloon observations), the critical thresholds in the composite QC procedure, including consensus average threshold T 1 and vertical shear threshold T 3 , are systematically discussed. And the performance of the BLP operated under precipitation is also evaluated. It is found that to ensure the high accuracy and high data collectable rate, the optimal range of subsets is determined to be 4 m/s. Although the number of data rejected by the combined algorithm of vertical shear examination and small median test is quite limited, it is proved that the algorithm is quite useful to recognize the outlier with a large discrepancy. And the optimal wind shear threshold T 3 can be recommended as 5 ms -1 /100m. During patchy precipitation, the quality of data measured by the four oblique beams (using the DBS measuring technique) can still be ensured. After the BLP data are quality controlled by the composite QC procedure, the output can show good agreement with the balloon observation.

75 FR 43190 - Statement of Organization, Functions, and Delegations of Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... human and animal health; (5) ensures scientific quality and ethical and regulatory compliance of center... investigations on the biology, ecology, and control of arthropod vectors of viral, rickettsial, and bacterial...

Intermediate quality control tests in the development of a superconducting RF cryomodule for CW operation

NASA Astrophysics Data System (ADS)

Pattalwar, Shrikant; Jones, Thomas; Strachan, John; Bate, Robert; Davies, Phil; McIntosh, Peter

2012-06-01

Through an international cryomodule collaboration, ASTeC at Daresbury Laboratory has taken the primary responsibility in leading the development of an optimised Superconducting RF (SRF) cryomodule, operating in CW mode for energy recovery facilities and other high duty cycle accelerators. For high beam current operation, Higher Order Mode (HOM) absorbers are critical components of the SRF Cryomodule, ensuring excessive heating of the accelerating structures and beam instabilities are effectively managed. This paper describes some of the cold tests conducted on the HOM absorbers and other critical components during the construction phase, to ensure that the quality and reliable cryomodule performance is maintained.

[A new strategy for Chinese medicine processing technologies: coupled with individuation processed and cybernetics].

PubMed

Zhang, Ding-kun; Yang, Ming; Han, Xue; Lin, Jun-zhi; Wang, Jia-bo; Xiao, Xiao-he

2015-08-01

The stable and controllable quality of decoction pieces is an important factor to ensure the efficacy of clinical medicine. Considering the dilemma that the existing standardization of processing mode cannot effectively eliminate the variability of quality raw ingredients, and ensure the stability between different batches, we first propose a new strategy for Chinese medicine processing technologies that coupled with individuation processed and cybernetics. In order to explain this thinking, an individual study case about different grades aconite is provided. We hope this strategy could better serve for clinical medicine, and promote the inheritance and innovation of Chinese medicine processing skills and theories.

[Testing of medicinal products produced from pooled plasma].

PubMed

Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

2014-10-01

Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs

PubMed Central

Fonjungo, Peter N.; Osmanov, Saladin; Kuritsky, Joel; Ndihokubwayo, Jean Bosco; Bachanas, Pam; Peeling, Rosanna W.; Timperi, Ralph; Fine, Glenn; Stevens, Wendy; Habiyambere, Vincent; Nkengasong, John N.

2016-01-01

Objective: The objective of the WHO/US President's Emergency Plan for AIDS Relief consultation was to discuss innovative strategies, offer guidance, and develop a comprehensive policy framework for implementing quality-assured HIV-related point-of-care testing (POCT). Methods: The consultation was attended by representatives from international agencies (WHO, UNICEF, UNITAID, Clinton Health Access Initiative), United States Agency for International Development, Centers for Disease Control and Prevention/President's Emergency Plan for AIDS Relief Cooperative Agreement Partners, and experts from more than 25 countries, including policy makers, clinicians, laboratory experts, and program implementers. Main outcomes: There was strong consensus among all participants that ensuring access to quality of POCT represents one of the key challenges for the success of HIV prevention, treatment, and care programs. The following four strategies were recommended: implement a newly proposed concept of a sustainable quality assurance cycle that includes careful planning; definition of goals and targets; timely implementation; continuous monitoring; improvements and adjustments, where necessary; and a detailed evaluation; the importance of supporting a cadre of workers [e.g. volunteer quality corps (Q-Corps)] with the role to ensure that the quality assurance cycle is followed and sustained; implementation of the new strategy should be seen as a step-wise process, supported by development of appropriate policies and tools; and joint partnership under the leadership of the ministries of health to ensure sustainability of implementing novel approaches. Conclusion: The outcomes of this consultation have been well received by program implementers in the field. The recommendations also laid the groundwork for developing key policy and quality documents for the implementation of HIV-related POCT. PMID:26807969

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

PubMed

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

2015-01-01

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

Sigma Metrics Across the Total Testing Process.

PubMed

Charuruks, Navapun

2017-03-01

Laboratory quality control has been developed for several decades to ensure patients' safety, from a statistical quality control focus on the analytical phase to total laboratory processes. The sigma concept provides a convenient way to quantify the number of errors in extra-analytical and analytical phases through the defect per million and sigma metric equation. Participation in a sigma verification program can be a convenient way to monitor analytical performance continuous quality improvement. Improvement of sigma-scale performance has been shown from our data. New tools and techniques for integration are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Radiation protection program for early detection of breast cancer in a mammography facility

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

Mariana, Villagomez Casimiro, E-mail: marjim10-66@ciencias.unam.mx, E-mail: cesar@fisica.unam.mx; Cesar, Ruiz Trejo, E-mail: marjim10-66@ciencias.unam.mx, E-mail: cesar@fisica.unam.mx; Ruby, Espejo Fonseca

Mammography is the best tool for early detection of Breast Cancer. In this diagnostic radiology modality it is necessary to establish the criteria to ensure the proper use and operation of the equipment used to obtain mammographic images in order to contribute to the safe use of ionizing radiation. The aim of the work was to implement at FUCAM-AC the radiation protection program which must be established for patients and radiation workers according to Mexican standards [1–4]. To achieve this goal, radiation protection and quality control manuals were elaborated [5]. Furthermore, a quality control program (QCP) in the mammography systemsmore » (analog/digital), darkroom included, has been implemented. Daily sensitometry, non-variability of the image quality, visualizing artifacts, revision of the equipment mechanical stability, compression force and analysis of repetition studies are some of the QCP routine tests that must be performed by radiological technicians of this institution as a set of actions to ensure the protection of patients. Image quality and patients dose assessment were performed on 4 analog equipment installed in 2 mobile units. In relation to dose assessment, all equipment passed the acceptance criteria (<3 mGy per projection). The image quality test showed that most images (70%)– presented artifacts. A brief summary of the results of quality control tests applied to the equipment and film processor are presented. To maintain an adequate level of quality and safety at FUCAM-AC is necessary that the proposed radiation protection program in this work is applied.« less

[Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

PubMed

Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

2014-07-01

Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

Innovative Training for Occupational Health and Infection Control Workplace Assessment in Health Care

ERIC Educational Resources Information Center

O'Hara, Lyndsay; Bryce, Elizabeth Ann; Scharf, Sydney; Yassi, Annalee

2012-01-01

A user-friendly, high quality workplace assessment field guide and an accompanying worksheet are invaluable tools for recognizing hazards in the hospital environment. These tools ensure that both front line workers as well as health and safety and infection control professionals can systematically evaluate hazards and formulate recommendations.…

Improving accuracy of unbound resilient modulus testing

DOT National Transportation Integrated Search

1997-07-01

The P46 Laboratory Startup and Quality Control Procedure was developed to ensure the accuracy and reliability of the resilient modulus data produced while testing soil and aggregate materials using closed-loop servo-hydraulic systems. It was develope...

Research on Objectives for High-School Biology

ERIC Educational Resources Information Center

Korgan, John J., Jr.; Wilson, John T.

1973-01-01

Describes procedures to develop instructional objectives for high school biology. Two kinds of objectives are identified as pre-objectives and performance objectives. Models to classify these in branches of biology and to ensure quality control are provided. (PS)

Diagnostic laboratory for bleeding disorders ensures efficient management of haemorrhagic disorders.

PubMed

Riddell, A; Chuansumrit, A; El-Ekiaby, M; Nair, S C

2016-07-01

Haemorrhagic disorders like Postpartum haemorrhage and Dengue haemorrhagic fever are life threatening and requires an active and efficient transfusion service that could provide the most appropriate blood product which could be effective in managing them. This would essentially require prompt identification of the coagulopathy so that the best available product can be given to the bleeding patient to correct the identified haemostatic defect which will help control the bleeding. This would only be possible if the transfusion service has a laboratory to correctly detect the haemostatic defect and that too with an accuracy and precision which is ensured by a good laboratory quality assurance practices. These same processes are necessary for the transfusion services to ensure the quality of the blood products manufactured by them and that it contains adequate amounts of haemostasis factors which will be good to be effective in the management of haemorrhagic disorders. These issues are discussed in detail individually in the management of postpartum haemorrhage and Dengue haemorrhagic fever including when these can help in the use of rFVIIa in Dengue haemorrhagic fever. The requirements to ensure good-quality blood products are made available for the management of these disorders and the same have also been described. © 2016 John Wiley & Sons Ltd.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA AND QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of field quality assurance and quality control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the Border study. Keywords: custody; QA/QC; field checks.

The U.S.-Mex...

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

PubMed

Aziz, Anwar

2011-01-01

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

Miller's best/enhanced practices for flour fortification at the flour mill.

PubMed

Johnson, Quentin W; Wesley, Annie S

2010-03-01

Cereal flour fortification has been identified as an effective mass fortification intervention as part of a national public health strategy to overcome micronutrient deficiencies and improve the health status of populations, especially women and children. The effectiveness of cereal flour fortification programs requires the use of micronutrient premixes that provide the desired health benefits. The Miller's Best/Enhanced Practices for Flour Fortification at the flour mill has been developed to provide specific guidance to millers and government officials to ensure that flour fortification practices are carried out in a way that results in the anticipated public health impact. The paper provides information specific to the use of micronutrient premixes, feeders, the fortification process, and quality control systems to ensure that both minimum and enhanced practices can be followed by the millers. Guidelines for basic and best/enhanced practices to be followed for each stage of the flour fortification process at the flour mill are presented. The paper is designed to be a companion to the Recommended Practices for the Production and Procurement of Premix used in Cereal Fortification Programs and supplementary to existing food quality manuals and systems, such as Good Manufacturing Practices, Food Quality Systems, and Hazard Analysis and Critical Control Points. Other stakeholders involved in flour fortification programs have the responsibility to follow best practices of their own to ensure optimum effectiveness.

Research on control strategy based on fuzzy PR for grid-connected inverter

NASA Astrophysics Data System (ADS)

Zhang, Qian; Guan, Weiguo; Miao, Wen

2018-04-01

In the traditional PI controller, there is static error in tracking ac signals. To solve the problem, the control strategy of a fuzzy PR and the grid voltage feed-forward is proposed. The fuzzy PR controller is to eliminate the static error of the system. It also adjusts parameters of PR controller in real time, which avoids the defect of fixed parameter fixed. The grid voltage feed-forward control can ensure the quality of current and improve the system's anti-interference ability when the grid voltage is distorted. Finally, the simulation results show that the system can output grid current with good quality and also has good dynamic and steady state performance.

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

PubMed

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

The World Optical Depth Research and Calibration Center (WORCC) quality assurance and quality control of GAW-PFR AOD measurements

NASA Astrophysics Data System (ADS)

Kazadzis, Stelios; Kouremeti, Natalia; Nyeki, Stephan; Gröbner, Julian; Wehrli, Christoph

2018-02-01

The World Optical Depth Research Calibration Center (WORCC) is a section within the World Radiation Center at Physikalisches-Meteorologisches Observatorium (PMOD/WRC), Davos, Switzerland, established after the recommendations of the World Meteorological Organization for calibration of aerosol optical depth (AOD)-related Sun photometers. WORCC is mandated to develop new methods for instrument calibration, to initiate homogenization activities among different AOD networks and to run a network (GAW-PFR) of Sun photometers. In this work we describe the calibration hierarchy and methods used under WORCC and the basic procedures, tests and processing techniques in order to ensure the quality assurance and quality control of the AOD-retrieved data.

Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

NASA Astrophysics Data System (ADS)

Cucu, Daniela; Woods, Mike

2008-08-01

The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee. According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures. When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results). Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results. Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance.

Automating PACS quality control with the Vanderbilt image processing enterprise resource

NASA Astrophysics Data System (ADS)

Esparza, Michael L.; Welch, E. Brian; Landman, Bennett A.

2012-02-01

Precise image acquisition is an integral part of modern patient care and medical imaging research. Periodic quality control using standardized protocols and phantoms ensures that scanners are operating according to specifications, yet such procedures do not ensure that individual datasets are free from corruption; for example due to patient motion, transient interference, or physiological variability. If unacceptable artifacts are noticed during scanning, a technologist can repeat a procedure. Yet, substantial delays may be incurred if a problematic scan is not noticed until a radiologist reads the scans or an automated algorithm fails. Given scores of slices in typical three-dimensional scans and widevariety of potential use cases, a technologist cannot practically be expected inspect all images. In large-scale research, automated pipeline systems have had great success in achieving high throughput. However, clinical and institutional workflows are largely based on DICOM and PACS technologies; these systems are not readily compatible with research systems due to security and privacy restrictions. Hence, quantitative quality control has been relegated to individual investigators and too often neglected. Herein, we propose a scalable system, the Vanderbilt Image Processing Enterprise Resource (VIPER) to integrate modular quality control and image analysis routines with a standard PACS configuration. This server unifies image processing routines across an institutional level and provides a simple interface so that investigators can collaborate to deploy new analysis technologies. VIPER integrates with high performance computing environments has successfully analyzed all standard scans from our institutional research center over the course of the last 18 months.

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

PubMed

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

2018-05-15

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

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

EPA Pesticide Factsheets

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

The drug regulatory and review process in Guyana.

PubMed

Woo-Ming, R B

1993-01-01

After the old "Sale of Food and Drugs" Ordinance, Cap. 144 was repealed, the new Food and Drugs Act was enacted in 1971. This new Act has considerable flexibility and gives the Minister extensive authority to make Regulations (for carrying out the purposes and provisions of the Act). The Act controls the manufacture, importation, sale, advertising, labeling, packaging, and distribution of drug samples, and the testing of drugs. The Act also controls raw materials and finished products of drugs at the point of entry into the country, with a single agency coordinating both the inspection and analytical services. Developing countries could ensure the procurement of safe, good quality, and effective drugs and devices with the enactment of a similar Food and Drugs Act only. Rapid assessment of Drug Safety, Quality and Efficacy is done through Guyana's participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. This certification scheme is highly commendable especially to third-world countries. The Food and Drug Regulations (1977) have several unique features for drug, cosmetic and device control and they allow for a system of centralized control with limited staff to enforce the legislation. In summary, enforcement of legislative control of imported pharmaceuticals and product evaluation can be considered strong points in the drug regulatory and review process in Guyana. A cautious attitude is observed so as to ensure efficacy, safety, and quality of drugs entering the market. This Drug Regulatory and Review Process is recommended for implementation by third-world countries with outdated drug legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

PubMed

Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

2011-11-01

This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

Standardized methods and quality control limits for agar and broth microdilution susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum.

PubMed

Waites, Ken B; Duffy, Lynn B; Bébéar, Cécile M; Matlow, Anne; Talkington, Deborah F; Kenny, George E; Totten, Patricia A; Bade, Donald J; Zheng, Xiaotian; Davidson, Maureen K; Shortridge, Virginia D; Watts, Jeffrey L; Brown, Steven D

2012-11-01

An international multilaboratory collaborative study was conducted to develop standard media and consensus methods for the performance and quality control of antimicrobial susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum using broth microdilution and agar dilution techniques. A reference strain from the American Type Culture Collection was designated for each species, which was to be used for quality control purposes. Repeat testing of replicate samples of each reference strain by participating laboratories utilizing both methods and different lots of media enabled a 3- to 4-dilution MIC range to be established for drugs in several different classes, including tetracyclines, macrolides, ketolides, lincosamides, and fluoroquinolones. This represents the first multilaboratory collaboration to standardize susceptibility testing methods and to designate quality control parameters to ensure accurate and reliable assay results for mycoplasmas and ureaplasmas that infect humans.

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

[Analysis of the results of the SEIMC External Quality Control Program. Year 2011].

PubMed

Ruiz de Gopegui Bordes, Enrique; Guna Serrano, M del Remedio; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Gimeno Cardona, Concepción

2013-02-01

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2011 controls. Overall, the results obtained in 2011 confirm the excellent skill and good technical standards found in previous years. Nevertheless, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls, such as those offered by the SEIMC program, in order to ensure maximal quality of microbiological tests. Copyright © 2013 Elsevier España, S.L. All rights reserved.

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.

THE MID-ATLANTIC INTEGRATED ASSESSMENT (MAIA)

EPA Science Inventory

Since its inception, EPA has focused its research and monitoring towards its regulatory requirements?to protect air and water quality, to control the use of pesticides and toxic substances, to ensure the safe production, handling, and disposal of industrial chemicals, and to clea...

Modeling of liquid flow in surface discontinuities

NASA Astrophysics Data System (ADS)

Lobanova, I. S.; Meshcheryakov, V. A.; Kalinichenko, A. N.

2018-01-01

Polymer composite and metallic materials have found wide application in various industries such as aviation, rocket, car manufacturing, ship manufacturing, etc. Many design elements need permanent quality control. Ensuring high quality and reliability of products is impossible without effective nondestructive testing methods. One of these methods is penetrant testing using penetrating substances based on liquid penetration into defect cavities. In this paper, we propose a model of liquid flow to determine the rates of filling the defect cavities with various materials and, based on this, to choose optimal control modes.

Multipurpose electroslag remelting furnace for modern energy and heavy engineering industry

NASA Astrophysics Data System (ADS)

Dub, A. V.; Dub, V. S.; Kriger, Yu. N.; Levkov, L. Ya.; Shurygin, D. A.; Kissel'man, M. A.; Nekhamin, C. M.; Chernyak, A. I.; Bessonov, A. V.; Kamantsev, S. V.; Sokolov, S. O.

2012-12-01

In 2011, a unique complex based on a multipurpose unit-type electroslag remelting (ESR) furnace is created to meet the demand for large high-quality solid and hollow billets for the products of power, atomic, petrochemical, and heavy machine engineering. This complex has modern low-frequency power supplies with a new control level that ensure a high homogeneity and quality of the billets and an increase in the engineering-and-economical performance of the production. A unique pilot ESR furnace is erected to adjust technological conditions and the main control system elements.

Measurement control workshop instructional materials

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

Gibbs, Philip; Harvel, Charles; Clark, John

2012-09-01

An essential element in an effective nuclear materials control and accountability (MC&A) program is the measurement of the nuclear material as it is received, moved, processed and shipped. Quality measurement systems and methodologies determine the accuracy of the accountability values. Implementation of a measurement control program is essential to ensure that the measurement systems and methodologies perform as expected. A measurement control program also allows for a determination of the level of confidence in the accounting values.

High perfomance liquid chromatography fingerprint analysis for quality control of brotowali (Tinospora crispa)

NASA Astrophysics Data System (ADS)

Syarifah, V. B.; Rafi, M.; Wahyuni, W. T.

2017-05-01

Brotowali (Tinospora crispa) is widely used in Indonesia as ingredient of herbal medicine formulation. To ensure the quality, safety, and efficacy of herbal medicine products, its chemical constituents should be continuously evaluated. High performance liquid chromatography (HPLC) fingerprint is one of powerful technique for this quality control process. In this study, HPLC fingerprint analysis method was developed for quality control of brotowali. HPLC analysis was performed in C18 column and detection was performed using photodiode array detector. The optimum mobile phase for brotowali fingerprint was acetonitrile (ACN) and 0.1% formic acid in gradient elution mode at a flow rate of 1 mL/min. The number of peaks detected in HPLC fingerprint of brotowali was 32 peaks and 23 peaks for stems and leaves, respectively. Berberine as marker compound was detected at retention time of 20.525 minutes. Evaluation of analytical performance including precision, reproducibility, and stability prove that this HPLC fingerprint analysis was reliable and could be applied for quality control of brotowali.

Case Studies in Modelling, Control in Food Processes.

PubMed

Glassey, J; Barone, A; Montague, G A; Sabou, V

This chapter discusses the importance of modelling and control in increasing food process efficiency and ensuring product quality. Various approaches to both modelling and control in food processing are set in the context of the specific challenges in this industrial sector and latest developments in each area are discussed. Three industrial case studies are used to demonstrate the benefits of advanced measurement, modelling and control in food processes. The first case study illustrates the use of knowledge elicitation from expert operators in the process for the manufacture of potato chips (French fries) and the consequent improvements in process control to increase the consistency of the resulting product. The second case study highlights the economic benefits of tighter control of an important process parameter, moisture content, in potato crisp (chips) manufacture. The final case study describes the use of NIR spectroscopy in ensuring effective mixing of dry multicomponent mixtures and pastes. Practical implementation tips and infrastructure requirements are also discussed.

Auditing of chromatographic data.

PubMed

Mabie, J T

1998-01-01

During a data audit, it is important to ensure that there is clear documentation and an audit trail. The Quality Assurance Unit should review all areas, including the laboratory, during the conduct of the sample analyses. The analytical methodology that is developed should be documented prior to sample analyses. This is an important document for the auditor, as it is the instrumental piece used by the laboratory personnel to maintain integrity throughout the process. It is expected that this document will give insight into the sample analysis, run controls, run sequencing, instrument parameters, and acceptance criteria for the samples. The sample analysis and all supporting documentation should be audited in conjunction with this written analytical method and any supporting Standard Operating Procedures to ensure the quality and integrity of the data.

Application of advanced data collection and quality assurance methods in open prospective study - a case study of PONS project.

PubMed

Wawrzyniak, Zbigniew M; Paczesny, Daniel; Mańczuk, Marta; Zatoński, Witold A

2011-01-01

Large-scale epidemiologic studies can assess health indicators differentiating social groups and important health outcomes of the incidence and mortality of cancer, cardiovascular disease, and others, to establish a solid knowledgebase for the prevention management of premature morbidity and mortality causes. This study presents new advanced methods of data collection and data management systems with current data quality control and security to ensure high quality data assessment of health indicators in the large epidemiologic PONS study (The Polish-Norwegian Study). The material for experiment is the data management design of the large-scale population study in Poland (PONS) and the managed processes are applied into establishing a high quality and solid knowledge. The functional requirements of the PONS study data collection, supported by the advanced IT web-based methods, resulted in medical data of a high quality, data security, with quality data assessment, control process and evolution monitoring are fulfilled and shared by the IT system. Data from disparate and deployed sources of information are integrated into databases via software interfaces, and archived by a multi task secure server. The practical and implemented solution of modern advanced database technologies and remote software/hardware structure successfully supports the research of the big PONS study project. Development and implementation of follow-up control of the consistency and quality of data analysis and the processes of the PONS sub-databases have excellent measurement properties of data consistency of more than 99%. The project itself, by tailored hardware/software application, shows the positive impact of Quality Assurance (QA) on the quality of outcomes analysis results, effective data management within a shorter time. This efficiency ensures the quality of the epidemiological data and indicators of health by the elimination of common errors of research questionnaires and medical measurements.

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

PubMed

Kay, Jack F

2012-08-01

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

V&V Plan for FPGA-based ESF-CCS Using System Engineering Approach.

NASA Astrophysics Data System (ADS)

Maerani, Restu; Mayaka, Joyce; El Akrat, Mohamed; Cheon, Jung Jae

2018-02-01

Instrumentation and Control (I&C) systems play an important role in maintaining the safety of Nuclear Power Plant (NPP) operation. However, most current I&C safety systems are based on Programmable Logic Controller (PLC) hardware, which is difficult to verify and validate, and is susceptible to software common cause failure. Therefore, a plan for the replacement of the PLC-based safety systems, such as the Engineered Safety Feature - Component Control System (ESF-CCS), with Field Programmable Gate Arrays (FPGA) is needed. By using a systems engineering approach, which ensures traceability in every phase of the life cycle, from system requirements, design implementation to verification and validation, the system development is guaranteed to be in line with the regulatory requirements. The Verification process will ensure that the customer and stakeholder’s needs are satisfied in a high quality, trustworthy, cost efficient and schedule compliant manner throughout a system’s entire life cycle. The benefit of the V&V plan is to ensure that the FPGA based ESF-CCS is correctly built, and to ensure that the measurement of performance indicators has positive feedback that “do we do the right thing” during the re-engineering process of the FPGA based ESF-CCS.

Spatial regression test for ensuring temperature data quality in southern Spain

NASA Astrophysics Data System (ADS)

Estévez, J.; Gavilán, P.; García-Marín, A. P.

2018-01-01

Quality assurance of meteorological data is crucial for ensuring the reliability of applications and models that use such data as input variables, especially in the field of environmental sciences. Spatial validation of meteorological data is based on the application of quality control procedures using data from neighbouring stations to assess the validity of data from a candidate station (the station of interest). These kinds of tests, which are referred to in the literature as spatial consistency tests, take data from neighbouring stations in order to estimate the corresponding measurement at the candidate station. These estimations can be made by weighting values according to the distance between the stations or to the coefficient of correlation, among other methods. The test applied in this study relies on statistical decision-making and uses a weighting based on the standard error of the estimate. This paper summarizes the results of the application of this test to maximum, minimum and mean temperature data from the Agroclimatic Information Network of Andalusia (southern Spain). This quality control procedure includes a decision based on a factor f, the fraction of potential outliers for each station across the region. Using GIS techniques, the geographic distribution of the errors detected has been also analysed. Finally, the performance of the test was assessed by evaluating its effectiveness in detecting known errors.

Trichinella diagnostics and control: mandatory and best practices for ensuring food safety.

PubMed

Gajadhar, Alvin A; Pozio, Edoardo; Gamble, H Ray; Nöckler, Karsten; Maddox-Hyttel, Charlotte; Forbes, Lorry B; Vallée, Isabelle; Rossi, Patrizia; Marinculić, Albert; Boireau, Pascal

2009-02-23

Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available.

Web Information Systems for Monitoring and Control of Indoor Air Quality at Subway Stations

NASA Astrophysics Data System (ADS)

Choi, Gi Heung; Choi, Gi Sang; Jang, Joo Hyoung

In crowded subway stations indoor air quality (IAQ) is a key factor for ensuring the safety, health and comfort of passengers. In this study, a framework for web-based information system in VDN environment for monitoring and control of IAQ in subway stations is suggested. Since physical variables that describing IAQ need to be closely monitored and controlled in multiple locations in subway stations, concept of distributed monitoring and control network using wireless media needs to be implemented. Connecting remote wireless sensor network and device (LonWorks) networks to the IP network based on the concept of VDN can provide a powerful, integrated, distributed monitoring and control performance, making a web-based information system possible.

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

Using fuzzy models in machining control system and assessment of sustainability

NASA Astrophysics Data System (ADS)

Grinek, A. V.; Boychuk, I. P.; Dantsevich, I. M.

2018-03-01

Description of the complex relationship of the optimum velocity with the temperature-strength state in the cutting zone for machining a fuzzy model is proposed. The fuzzy-logical conclusion allows determining the processing speed, which ensures effective, from the point of view of ensuring the quality of the surface layer, the temperature in the cutting zone and the maximum allowable cutting force. A scheme for stabilizing the temperature-strength state in the cutting zone using a nonlinear fuzzy PD–controller is proposed. The stability of the nonlinear system is estimated with the help of grapho–analytical realization of the method of harmonic balance and by modeling in MatLab.

--No Title--

Science.gov Websites

, the user is responsbile for controlling the quality of observational data # and ensuring data is also # # OUTPUTS: # 1) observational data (named data_obs) and Model data (named data_model) # stored under " observational and model data, stored in correct locations # 2) "data" and "figures" folders

40 CFR 49.121 - Introduction.

Code of Federal Regulations, 2012 CFR

2012-07-01

... air pollution sources located within Indian reservations in Idaho, Oregon, and Washington that are appropriate in order to ensure a basic level of air pollution control and to protect public health and welfare... quality situations within Indian reservations, the known sources of air pollution, the needs and concerns...

40 CFR 49.121 - Introduction.

Code of Federal Regulations, 2014 CFR

2014-07-01

... air pollution sources located within Indian reservations in Idaho, Oregon, and Washington that are appropriate in order to ensure a basic level of air pollution control and to protect public health and welfare... quality situations within Indian reservations, the known sources of air pollution, the needs and concerns...

40 CFR 49.121 - Introduction.

Code of Federal Regulations, 2013 CFR

2013-07-01

... air pollution sources located within Indian reservations in Idaho, Oregon, and Washington that are appropriate in order to ensure a basic level of air pollution control and to protect public health and welfare... quality situations within Indian reservations, the known sources of air pollution, the needs and concerns...

40 CFR 49.121 - Introduction.

Code of Federal Regulations, 2011 CFR

2011-07-01

... air pollution sources located within Indian reservations in Idaho, Oregon, and Washington that are appropriate in order to ensure a basic level of air pollution control and to protect public health and welfare... quality situations within Indian reservations, the known sources of air pollution, the needs and concerns...

European union water policy--tasks for implementing "Water Framework Directive" in pre-accession countries.

PubMed

Sözen, Seval; Avcioglu, Ebru; Ozabali, Asli; Görgun, Erdem; Orhon, Derin

2003-08-01

Water Framework Directive aiming to maintain and improve the aquatic environment in the EU was launched by the European Parliament in 2000. According to this directive, control of quantity is an ancillary element in securing good water quality and therefore measures on quantity, serving the objective of ensuring good quality should also be established. Accordingly, it is a comprehensive and coordinated package that will ensure all European waters to be protected according to a common standard. Therefore, it refers to all other Directives related to water resources management such as Urban Wastewater Treatment Directive Nitrates Directive, Drinking Water Directive, Integrated Pollution Prevention Control etc. Turkey, as a candidate state targeting full-membership, should comply the necessary preparations for the implementation of the "Water Framework Directive" as soon as possible. In this study, the necessary legislative, political, institutional, and technical attempts of the pre-accession countries have been discussed and effective recommendations have been offered for future activities in Turkey.

Quality Control of Structural MRI Images Applied Using FreeSurfer—A Hands-On Workflow to Rate Motion Artifacts

PubMed Central

Backhausen, Lea L.; Herting, Megan M.; Buse, Judith; Roessner, Veit; Smolka, Michael N.; Vetter, Nora C.

2016-01-01

In structural magnetic resonance imaging motion artifacts are common, especially when not scanning healthy young adults. It has been shown that motion affects the analysis with automated image-processing techniques (e.g., FreeSurfer). This can bias results. Several developmental and adult studies have found reduced volume and thickness of gray matter due to motion artifacts. Thus, quality control is necessary in order to ensure an acceptable level of quality and to define exclusion criteria of images (i.e., determine participants with most severe artifacts). However, information about the quality control workflow and image exclusion procedure is largely lacking in the current literature and the existing rating systems differ. Here, we propose a stringent workflow of quality control steps during and after acquisition of T1-weighted images, which enables researchers dealing with populations that are typically affected by motion artifacts to enhance data quality and maximize sample sizes. As an underlying aim we established a thorough quality control rating system for T1-weighted images and applied it to the analysis of developmental clinical data using the automated processing pipeline FreeSurfer. This hands-on workflow and quality control rating system will aid researchers in minimizing motion artifacts in the final data set, and therefore enhance the quality of structural magnetic resonance imaging studies. PMID:27999528

Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

PubMed

Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

2013-09-01

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

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

Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

COMP report: CPQR technical quality control guidelines for low-dose-rate permanent seed brachytherapy.

PubMed

Beaulieu, Luc; Radford, Dee-Ann; Eduardo Villarreal-Barajas, J

2018-03-14

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article contains detailed performance objectives and safety criteria for low-dose-rate (LDR) permanent seed brachytherapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

36 CFR § 1260.38 - How does the NDC ensure the quality of declassification reviews?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true How does the NDC ensure the quality of declassification reviews? § 1260.38 Section § 1260.38 Parks, Forests, and Public Property... INFORMATION The National Declassification Center (NDC) § 1260.38 How does the NDC ensure the quality of...

The Transforming Maternity Care Project: Goals, Methods, and Outcomes of a National Maternity Care Policy Initiative, With Construction of a Theoretical Model to Explain the Process

DTIC Science & Technology

2011-03-21

to and receive comprehensive high-quality, high-value reproductive health and maternity care. • Comprehensive health care reform strategies...and its implementation, ensure that access to comprehensive, high-quality reproductive health and maternity care services are essential benefits for... Reproductive Health, Centers for Disease Control and Prevention Stakeholder Workgroup Consumers and their Advocates Chair: Judy Norsigian

Development of Range Design Elements and Quality Control/Quality Assurance Guidance to Reduce Maintenance Requirements on Training Ranges

DTIC Science & Technology

2006-11-01

exercises. Potential Resolution: 1. Installations must ensure that they understand the composition of civilian populations outside of their...Installation trainers, SRP Support Agency trainers or contract training specialists should layout each range based on the composition defined in the...defined time limit to respond to submittals with a pre-defined team member composition so that changes could be reviewed consistently. Only mission

Regulatory observations in bioanalytical determinations.

PubMed

Viswanathan, C T

2010-07-01

The concept of measuring analytes in biological media is a long-established area of the quantitative sciences that is employed in many sectors. While academic research and R&D units of private firms have been in the forefront of developing complex methodologies, it is the regulatory environment that has brought the focus and rigor to the quality control of the quantitative determination of drug concentration in biological samples. In this article, the author examines the regulatory findings discovered during the course of several years of auditing bioanalytical work. The outcomes of these findings underscore the importance of quality method validation to ensure the reliability of the data generated. The failure to ensure the reliability of these data can lead to potential risks in the health management of millions of people in the USA.

The Modern Measurement Technology And Checking Of Shafs Parameters

NASA Astrophysics Data System (ADS)

Tichá, Šárka; Botek, Jan

2015-12-01

This paper is focused on rationalization checking parameters of shaft in companies engaged in the production of components of electric motors, wind turbines and vacuum systems. Customers increasing constantly their requirements to ensure the overall quality of the product, i.e. the quality of machining, dimensional and shape accuracy and overall purity of the subscribed products. The aim of this paper is to introduce using modern measurement technology in controlling these components and compare the results with existing control methodology. The main objective of this rationalization is to eliminate mistakes and shortcomings of current inspection methods.

Report: Weiss, Sugar, Dvorak & Dusek, Ltd., Single Audit of the Delta Institute and Affiliates for Year Ended June 30, 2003

EPA Pesticide Factsheets

Report #2006-S-00004, August 17, 2006. Weiss, Sugar, Dvorak & Dusek, Ltd., did not have sufficient quality control review procedures in place to ensure that all audit work performed was adequately supported by documentary evidence.

Handling qualities effects of display latency

NASA Technical Reports Server (NTRS)

King, David W.

1993-01-01

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

Quality assurance and ergonomics in the mammography department.

PubMed

Reynolds, April

2014-01-01

Quality assurance (QA) in mammography is a system of checks that helps ensure the proper functioning of imaging equipment and processes. Ergonomics is a scientific approach to arranging the work environment to reduce the risk of work-related injuries while increasing staff productivity and job satisfaction. This article reviews both QA and ergonomics in mammography and explains how they work together to create a safe and healthy environment for radiologic technologists and their patients. QA and quality control requirements in mammography are discussed, along with ergonomic best practices in the mammography setting.

Partnership for Continuous Improvement

NASA Technical Reports Server (NTRS)

1990-01-01

The proceedings are presented of the sixth annual conference on quality control between NASA and its contractors. The emphasis is placed on a commitment to quality and excellence that guarantees mission success. A forum is provided for representatives from government, industry, and academia to exchange ideas and experiences, encouraging total quality performance that results in high quality products and services. Key points are highlighted from the presentations and activities are described that have resulted in a broad range of improvements in products and services from government, industry, and academia. Long term commitment to quality is an essential requirement that ensures future success. That commitment reinterates the dedication to excellence in space exploration and to national quality and productivity improvement.

Implementation of Quality Assurance and Quality Control Measures in the National Phenology Database

NASA Astrophysics Data System (ADS)

Gerst, K.; Rosemartin, A.; Denny, E. G.; Marsh, L.; Barnett, L.

2015-12-01

The USA National Phenology Network (USA-NPN; www.usanpn.org) serves science and society by promoting a broad understanding of plant and animal phenology and the relationships among phenological patterns and environmental change. The National Phenology Database has over 5.5 million observation records for plants and animals for the period 1954-2015. These data have been used in a number of science, conservation and resource management applications, including national assessments of historical and potential future trends in phenology, regional assessments of spatio-temporal variation in organismal activity, and local monitoring for invasive species detection. Customizable data downloads are freely available, and data are accompanied by FGDC-compliant metadata, data-use and data-attribution policies, and vetted documented methodologies and protocols. The USA-NPN has implemented a number of measures to ensure both quality assurance and quality control. Here we describe the resources that have been developed so that incoming data submitted by both citizen and professional scientists are reliable; these include training materials, such as a botanical primer and species profiles. We also describe a number of automated quality control processes applied to incoming data streams to optimize data output quality. Existing and planned quality control measures for output of raw and derived data include: (1) Validation of site locations, including latitude, longitude, and elevation; (2) Flagging of records that conflict for a given date for an individual plant; (3) Flagging where species occur outside known ranges; (4) Flagging of records when phenophases occur outside of the plausible order for a species; (5) Flagging of records when intensity measures do not follow a plausible progression for a phenophase; (6) Flagging of records when a phenophase occurs outside of the plausible season, and (7) Quantification of precision and uncertainty for estimation of phenological metrics. Finally, we will describe preliminary work to develop methods for outlier detection that will inform plausibility checks. Ultimately we aim to maximize data quality of USA-NPN data and data products to ensure that this database can continue to be reliably applied for science and decision-making for multiple scales and applications.

Interaction of feel system and flight control system dynamics on lateral flying qualities

NASA Technical Reports Server (NTRS)

Bailey, R. E.; Knotts, L. H.

1990-01-01

An experimental investigation of the influence of lateral feel system characteristics on fighter aircraft roll flying qualities was conducted using the variable stability USAF NT-33. Forty-two evaluation flights were flown by three engineering test pilots. The investigation utilized the power approach, visual landing task and up-and-away tasks including formation, gun tracking, and computer-generated compensatory attitude tracking tasks displayed on the Head-Up Display. Experimental variations included the feel system frequency, force-deflection gradient, control system command type (force or position input command), aircraft roll mode time constant, control system prefilter frequency, and control system time delay. The primary data were task performance records and evaluation pilot comments and ratings using the Cooper-Harper scale. The data highlight the unique and powerful effect of the feel system of flying qualities. The data show that the feel system is not 'equivalent' in flying qualities influence to analogous control system elements. A lower limit of allowable feel system frequency appears warranted to ensure good lateral flying qualities. Flying qualities criteria should most properly treat the feel system dynamic influence separately from the control system, since the input and output of this dynamic element is apparent to the pilot and thus, does not produce a 'hidden' effect.

Monitoring Welding-Gas Quality

NASA Technical Reports Server (NTRS)

Huddleston, Kevin L.

1988-01-01

System monitors welding gas to ensure characteristics within predetermined values. Responds to changes that might go unnoticed by human operator and acts quickly to prevent weld defects. Electronic pressure controller employs various amounts of gain, equalization, and compensation to respond to changes in gas-supply pressure. Works in conjuction with pressure/oxygen/moisture monitor.

40 CFR 52.725 - Control strategy: Particulates.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Approval—On March 19, 1996, and October 15, 1996, Illinois submitted requests to redesignate the Granite... Quality Standards (NAAQS), as well as a maintenance plan for the Granite City area to ensure continued... approval of Illinois' May 15, 1992, SIP submittal for the Lake Calumet (SE Chicago), McCook, and Granite...

Can I Trust ORE Reports?

ERIC Educational Resources Information Center

Feedback, 1984

1984-01-01

This issue of FEEDBACK, a newsletter produced by the the Austin Independent School District Office of Research and Evaluation (ORE), illustrates the accuracy, validity, and fairness of ORE reports. The independence of the reports is explained. Internal and external quality controls are used to ensure reliability and accuracy of the reports.…

Establishment of effective control factors to achieve federal enforcement consistency with the Highway Beautification Act : [research summary].

DOT National Transportation Integrated Search

2017-10-01

One of the pleasures of driving in Florida is enjoying a beautiful and diverse landscape. The quality of this view is critical to a states image for visitors and those considering relocation as well as to residents enjoyment. To ensure the cont...

Education by Choice: The Case for Family Control.

ERIC Educational Resources Information Center

Coons, John E.; Sugarman, Stephen D.

This book examines the philosophical issues, possible variations, and implementation of voucher plans of educational choice. The voucher system proposed here (the Quality Choice Model) is based on the assumption that a voucher system can ensure the equal provision of educational resources to children regardless of residential mobility or ability…

40 CFR 49.121 - Introduction.

Code of Federal Regulations, 2010 CFR

2010-07-01

... in order to ensure a basic level of air pollution control and to protect public health and welfare... quality situations within Indian reservations, the known sources of air pollution, the needs and concerns... Reservations in EPA Region 10” apply to air pollution sources on a particular Indian reservation when EPA has...

21 CFR 820.130 - Device packaging.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

Ensuring and Improving Information Quality for Earth Science Data and Products Role of the ESIP Information Quality Cluster

NASA Technical Reports Server (NTRS)

Ramapriyan, H. K. (Rama); Peng, Ge; Moroni, David; Shie, Chung-Lin

2016-01-01

Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

Ensuring and Improving Information Quality for Earth Science Data and Products: Role of the ESIP Information Quality Cluster

NASA Technical Reports Server (NTRS)

Ramapriyan, Hampapuram; Peng, Ge; Moroni, David; Shie, Chung-Lin

2016-01-01

Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality - scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

Modelling the CDK-dependent transcription cycle in fission yeast.

PubMed

Sansó, Miriam; Fisher, Robert P

2013-12-01

CDKs (cyclin-dependent kinases) ensure directionality and fidelity of the eukaryotic cell division cycle. In a similar fashion, the transcription cycle is governed by a conserved subfamily of CDKs that phosphorylate Pol II (RNA polymerase II) and other substrates. A genetic model organism, the fission yeast Schizosaccharomyces pombe, has yielded robust models of cell-cycle control, applicable to higher eukaryotes. From a similar approach combining classical and chemical genetics, fundamental principles of transcriptional regulation by CDKs are now emerging. In the present paper, we review the current knowledge of each transcriptional CDK with respect to its substrate specificity, function in transcription and effects on chromatin modifications, highlighting the important roles of CDKs in ensuring quantity and quality control over gene expression in eukaryotes.

A Quality Assurance Initiative for Commercial-Scale Production in High-Throughput Cryopreservation of Blue Catfish Sperm

PubMed Central

Hu, E; Liao, T. W.; Tiersch, T. R.

2013-01-01

Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356

XRF inductive bead fusion and PLC based control system

NASA Astrophysics Data System (ADS)

Zhu, Jin-hong; Wang, Ying-jie; Shi, Hong-xin; Chen, Qing-ling; Chen, Yu-xi

2009-03-01

In order to ensure high-quality X-ray fluorescence spectrometry (XRF) analysis, an inductive bead fusion machine was developed. The prototype consists of super-audio IGBT induction heating power supply, rotation and swing mechanisms, and programmable logic controller (PLC). The system can realize sequence control, mechanical movement control, output current and temperature control. Experimental results show that the power supply can operate at an ideal quasi-resonant state, in which the expected power output and the required temperature can be achieved for rapid heating and the uniform formation of glass beads respectively.

[Quality assurance in interventional cardiology].

PubMed

Gülker, H

2009-10-01

Quality assurance in clinical studies aiming at approval of pharmaceutical products is submitted to strict rules, controls and auditing regulations. Comparative instruments to ensure quality in diagnostic and therapeutic procedures are not available in interventional cardiology, likewise in other fields of cardiovascular medicine. Quality assurance simply consists of "quality registers" with basic data not externally controlled. Based on the experiences of clinical studies and their long history of standardization it is assumed that these data may be severely flawed thus being inappropriate to set standards for diagnostic and therapeutic strategies. The precondition for quality assurance are quality data. In invasive coronary angiography and intervention medical indications, the decision making process interventional versus surgical revascularization, technical performance and after - care are essential aspects affecting quality of diagnostics and therapy. Quality data are externally controlled data. To collect quality data an appropriate infrastructure is a necessary precondition which is not existent. For an appropriate infrastructure investments have to be done both to build up as well as to sustain the necessary preconditions. As long as there are no infrastructure and no investments there will be no "quality data". There exist simply registers of data which are not proved to be a basis for significant assurance and enhancement in quality in interventional coronary cardiology. Georg Thieme Verlag KG Stuttgart, New York.

Implementing a Data Quality Strategy to Simplify Access to Data

NASA Astrophysics Data System (ADS)

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

2016-12-01

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

The Prevalence and Control of Bacillus and Related Spore-Forming Bacteria in the Dairy Industry.

PubMed

Gopal, Nidhi; Hill, Colin; Ross, Paul R; Beresford, Tom P; Fenelon, Mark A; Cotter, Paul D

2015-01-01

Milk produced in udder cells is sterile but due to its high nutrient content, it can be a good growth substrate for contaminating bacteria. The quality of milk is monitored via somatic cell counts and total bacterial counts, with prescribed regulatory limits to ensure quality and safety. Bacterial contaminants can cause disease, or spoilage of milk and its secondary products. Aerobic spore-forming bacteria, such as those from the genera Sporosarcina, Paenisporosarcina, Brevibacillus, Paenibacillus, Geobacillus and Bacillus, are a particular concern in this regard as they are able to survive industrial pasteurization and form biofilms within pipes and stainless steel equipment. These single or multiple-species biofilms become a reservoir of spoilage microorganisms and a cycle of contamination can be initiated. Indeed, previous studies have highlighted that these microorganisms are highly prevalent in dead ends, corners, cracks, crevices, gaskets, valves and the joints of stainless steel equipment used in the dairy manufacturing plants. Hence, adequate monitoring and control measures are essential to prevent spoilage and ensure consumer safety. Common controlling approaches include specific cleaning-in-place processes, chemical and biological biocides and other novel methods. In this review, we highlight the problems caused by these microorganisms, and discuss issues relating to their prevalence, monitoring thereof and control with respect to the dairy industry.

The Prevalence and Control of Bacillus and Related Spore-Forming Bacteria in the Dairy Industry

PubMed Central

Gopal, Nidhi; Hill, Colin; Ross, Paul R.; Beresford, Tom P.; Fenelon, Mark A.; Cotter, Paul D.

2015-01-01

Milk produced in udder cells is sterile but due to its high nutrient content, it can be a good growth substrate for contaminating bacteria. The quality of milk is monitored via somatic cell counts and total bacterial counts, with prescribed regulatory limits to ensure quality and safety. Bacterial contaminants can cause disease, or spoilage of milk and its secondary products. Aerobic spore-forming bacteria, such as those from the genera Sporosarcina, Paenisporosarcina, Brevibacillus, Paenibacillus, Geobacillus and Bacillus, are a particular concern in this regard as they are able to survive industrial pasteurization and form biofilms within pipes and stainless steel equipment. These single or multiple-species biofilms become a reservoir of spoilage microorganisms and a cycle of contamination can be initiated. Indeed, previous studies have highlighted that these microorganisms are highly prevalent in dead ends, corners, cracks, crevices, gaskets, valves and the joints of stainless steel equipment used in the dairy manufacturing plants. Hence, adequate monitoring and control measures are essential to prevent spoilage and ensure consumer safety. Common controlling approaches include specific cleaning-in-place processes, chemical and biological biocides and other novel methods. In this review, we highlight the problems caused by these microorganisms, and discuss issues relating to their prevalence, monitoring thereof and control with respect to the dairy industry. PMID:26733963

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

PubMed

Içten, Elçin; Giridhar, Arun; Nagy, Zoltan K; Reklaitis, Gintaras V

2016-04-01

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

Improving the Quality of Welding Seam of Automatic Welding of Buckets Based on TCP

NASA Astrophysics Data System (ADS)

Hu, Min

2018-02-01

Since February 2014, the welding defects of the automatic welding line of buckets have been frequently appeared. The average repair time of each bucket is 26min, which seriously affects the production efficiency and welding quality. We conducted troubleshooting, and found the main reasons for the welding defects of the buckets were the deviations of the center points of the robot tools and the poor quality of the locating welding. We corrected the gripper, welding torch, and accuracy of repeat positioning of robots to control the quality of positioning welding. The welding defect rate of buckets was reduced greatly, ensuring the production efficiency and welding quality.

Development and Validation of a Kit to Measure Drink Antioxidant Capacity Using a Novel Colorimeter.

PubMed

Priftis, Alexandros; Stagos, Dimitrios; Tzioumakis, Nikolaos; Konstantinopoulos, Konstantinos; Patouna, Anastasia; Papadopoulos, Georgios E; Tsatsakis, Aristides; Kouretas, Dimitrios

2016-08-30

Measuring the antioxidant capacity of foods is essential, as a means of quality control to ensure that the final product reaching the consumer will be of high standards. Despite the already existing assays with which the antioxidant activity is estimated, new, faster and low cost methods are always sought. Therefore, we have developed a novel colorimeter and combined it with a slightly modified DPPH assay, thus creating a kit that can assess the antioxidant capacity of liquids (e.g., different types of coffee, beer, wine, juices) in a quite fast and low cost manner. The accuracy of the colorimeter was ensured by comparing it to a fully validated Hitachi U-1900 spectrophotometer, and a coefficient was calculated to eliminate the observed differences. In addition, a new, user friendly software was developed, in order to render the procedure as easy as possible, while allowing a central monitoring of the obtained results. Overall, a novel kit was developed, with which the antioxidant activity of liquids can be measured, firstly to ensure their quality and secondly to assess the amount of antioxidants consumed with the respective food.

Test Analysis Tools to Ensure Higher Quality of On-Board Real Time Software for Space Applications

NASA Astrophysics Data System (ADS)

Boudillet, O.; Mescam, J.-C.; Dalemagne, D.

2008-08-01

EADS Astrium Space Transportation, in its Les Mureaux premises, is responsible for the French M51 nuclear deterrent missile onboard SW. There was also developed over 1 million of line of code, mostly in ADA, for the Automated Transfer Vehicle (ATV) onboard SW and the flight control SW of the ARIANE5 launcher which has put it into orbit. As part of the ATV SW, ASTRIUM ST has developed the first Category A SW ever qualified for a European space application. To ensure that all these embedded SW have been developed with the highest quality and reliability level, specific development tools have been designed to cover the steps of source code verification, automated validation test or complete target instruction coverage verification. Three of such dedicated tools are presented here.

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 to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. THE PRIMARY FUNCTION OF THE STANDARDS LABORATORY WAS TO ENSURE AND IMPLEMENT A SYSTEM OF QUALITY CONTROL FOR INCOMING MATERIALS USED IN MANUFACTURING PROCESSES. SEVERAL ENGINEERING CONTROLS WERE USED TO ASSURE ACCURACY OF THE CALIBRATION PROCESSES INCLUDING: FLEX-FREE GRANITE TABLES, AIR LOCKED DOORS, TEMPERATURE CONTROLS, AND A SUPER-CLEAN ENVIRONMENT - Rocky Flats Plant, Standards Laboratory, Immediately north of 215A water tower & adjacent to Third Street, Golden, Jefferson County, CO

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical preparations. Copyright © 2017 John Wiley & Sons, Ltd.

Discovery and identification of quality markers of Chinese medicine based on pharmacokinetic analysis.

PubMed

He, Jun; Feng, Xinchi; Wang, Kai; Liu, Changxiao; Qiu, Feng

2018-02-28

Quality control of Chinese medicine (CM) is an effective measure to ensure the safety and efficacy of CM in clinical practice, which is also a key factor to restrict the modernization process of CM. Various chemical components exist in CM and the determination of several chemical components is the main approach for quality control of vast majority of CM in the present. However, many components determined lack not only specificity, but also biological activities. This is bound to greatly reduce the actual value of quality standard of CM. Professor Changxiao Liu proposed the "quality marker" (Q-marker) concept to ensure the standardization and rationalization for the quality control of CM. As we all know, CMs are taken orally in most cases and could be extensively metabolized in vivo. Both prototype components and the metabolites could be the actual therapeutic material basis. Pharmacokinetic studies could benefit the elucidation of actual therapeutic material basis which is closely related to the identification of Q-markers. Therefore, a new strategy about Q-marker was proposed based on the pharmacokinetic analysis of CM, hoping to provide some ideas for the discovery and identification of Q-marker. The relationship between pharmacokinetic studies and the identification of Q-markers was demonstrated in this review and a new strategy was proposed. Starting from the pharmacokinetic analysis, reverse tracing of the prototype active components and the potential prodrugs in CM were conducted first and the therapeutic material basis were identified as Q-markers. Then, modern analytical techniques and methods were applied to obtain comprehensive quality control for these constituents. Several CMs including gingko biloba, ginseng, Periplocae Cortex, Mori Cortex, Bupleuri Radix and Scutellariae Radix were listed as examples to clarify how the new strategy could be applied. Pharmacokinetic studies play an important role for the elucidation of therapeutic material basis of CM and the identification of Q-markers and it should be taken into account during the process of the investigation of Q-marker. Copyright © 2018 Elsevier GmbH. All rights reserved.

Value function in economic growth model

NASA Astrophysics Data System (ADS)

Bagno, Alexander; Tarasyev, Alexandr A.; Tarasyev, Alexander M.

2017-11-01

Properties of the value function are examined in an infinite horizon optimal control problem with an unlimited integrand index appearing in the quality functional with a discount factor. Optimal control problems of such type describe solutions in models of economic growth. Necessary and sufficient conditions are derived to ensure that the value function satisfies the infinitesimal stability properties. It is proved that value function coincides with the minimax solution of the Hamilton-Jacobi equation. Description of the growth asymptotic behavior for the value function is provided for the logarithmic, power and exponential quality functionals and an example is given to illustrate construction of the value function in economic growth models.

Quality Assurance of Real-Time Oceanographic Data from the Cabled Array of the Ocean Observatories Initiative

NASA Astrophysics Data System (ADS)

Kawka, O. E.; Nelson, J. S.; Manalang, D.; Kelley, D. S.

2016-02-01

The Cabled Array component of the NSF-funded Ocean Observatories Initiative (OOI) provides access to real-time physical, chemical, geological, and biological data from water column and seafloor platforms/instruments at sites spanning the southern half of the Juan de Fuca Plate. The Quality Assurance (QA) program for OOI data is designed to ensure that data products meet OOI science requirements. This overall data QA plan establishes the guidelines for assuring OOI data quality and summarizes Quality Control (QC) protocols and procedures, based on best practices, which can be utilized to ensure the highest quality data across the OOI program. This presentation will highlight, specifically, the QA/QC approach being utilized for the OOI Cabled Array infrastructure and data and will include a summary of both shipboard and shore-based protocols currently in use. Aspects addressed will be pre-deployment instrument testing and calibration checks, post-deployment and pre-recovery field verification of data, and post-recovery "as-found" testing of instruments. Examples of QA/QC data will be presented and specific cases of cabled data will be discussed in the context of quality assessments and adjustment/correction of OOI datasets overall for inherent sensor drift and/or instrument fouling.

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

PubMed

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

2004-10-01

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

The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

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

An employer's experience with infertility coverage: a case study.

PubMed

Silverberg, Kaylen; Meletiche, Dennis; Del Rosario, Gina

2009-12-01

A case study of Southwest Airlines, a Fortune 500 company, demonstrates that a well-designed infertility coverage plan can control resource use. This successful model could be used by employers who wish to ensure that their employees have access to high-quality, cost-effective infertility services in a managed-care environment.

49 CFR 236.1015 - PTC Safety Plan content requirements and PTC System Certification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... established and can maintain a quality control system for PTC system design and manufacturing acceptable to... an explanation of the design principles and assumptions; (3) A risk assessment of the as-built PTC... the specific procedures and test equipment necessary to ensure the safe and proper installation...

Progress in Brewing Science and Beer Production.

PubMed

Bamforth, C W

2017-06-07

The brewing of beer is an ancient biotechnology, the unit processes of which have not changed in hundreds of years. Equally, scientific study within the brewing industry not only has ensured that modern beer making is highly controlled, leading to highly consistent, high-quality, healthful beverages, but also has informed many other fermentation-based industries.

76 FR 24060 - Proposed Extension of Existing Information Collection; Testing, Evaluation, and Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... Extension of Existing Information Collection; Testing, Evaluation, and Approval of Mining Products AGENCY... Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be..., testing, approval and certification, and quality control of mining equipment and components, materials...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Quality and Efficiency Improvement Tools for Every Radiologist.

PubMed

Kudla, Alexei U; Brook, Olga R

2018-06-01

In an era of value-based medicine, data-driven quality improvement is more important than ever to ensure safe and efficient imaging services. Familiarity with high-value tools enables all radiologists to successfully engage in quality and efficiency improvement. In this article, we review the model for improvement, strategies for measurement, and common practical tools with real-life examples that include Run chart, Control chart (Shewhart chart), Fishbone (Cause-and-Effect or Ishikawa) diagram, Pareto chart, 5 Whys, and Root Cause Analysis. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Effect of poor control of film processors on mammographic image quality.

PubMed

Kimme-Smith, C; Sun, H; Bassett, L W; Gold, R H

1992-11-01

With the increasingly stringent standards of image quality in mammography, film processor quality control is especially important. Current methods are not sufficient for ensuring good processing. The authors used a sensitometer and densitometer system to evaluate the performance of 22 processors at 16 mammographic facilities. Standard sensitometric values of two films were established, and processor performance was assessed for variations from these standards. Developer chemistry of each processor was analyzed and correlated with its sensitometric values. Ten processors were retested, and nine were found to be out of calibration. The developer components of hydroquinone, sulfites, bromide, and alkalinity varied the most, and low concentrations of hydroquinone were associated with lower average gradients at two facilities. Use of the sensitometer and densitometer system helps identify out-of-calibration processors, but further study is needed to correlate sensitometric values with developer component values. The authors believe that present quality control would be improved if sensitometric or other tests could be used to identify developer components that are out of calibration.

Quality-assurance and data management plan for groundwater activities by the U.S. Geological Survey in Kansas, 2014

USGS Publications Warehouse

Putnam, James E.; Hansen, Cristi V.

2014-01-01

As the Nation’s principle earth-science information agency, the U.S. Geological Survey (USGS) is depended on to collect data of the highest quality. This document is a quality-assurance plan for groundwater activities (GWQAP) of the Kansas Water Science Center. The purpose of this GWQAP is to establish a minimum set of guidelines and practices to be used by the Kansas Water Science Center to ensure quality in groundwater activities. Included within these practices are the assignment of responsibilities for implementing quality-assurance activities in the Kansas Water Science Center and establishment of review procedures needed to ensure the technical quality and reliability of the groundwater products. In addition, this GWQAP is intended to complement quality-assurance plans for surface-water and water-quality activities and similar plans for the Kansas Water Science Center and general project activities throughout the USGS. This document provides the framework for collecting, analyzing, and reporting groundwater data that are quality assured and quality controlled. This GWQAP presents policies directing the collection, processing, analysis, storage, review, and publication of groundwater data. In addition, policies related to organizational responsibilities, training, project planning, and safety are presented. These policies and practices pertain to all groundwater activities conducted by the Kansas Water Science Center, including data-collection programs, interpretive and research projects. This report also includes the data management plan that describes the progression of data management from data collection to archiving and publication.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Requirements for modeling airborne microbial contamination in space stations

NASA Astrophysics Data System (ADS)

Van Houdt, Rob; Kokkonen, Eero; Lehtimäki, Matti; Pasanen, Pertti; Leys, Natalie; Kulmala, Ilpo

2018-03-01

Exposure to bioaerosols is one of the facets that affect indoor air quality, especially for people living in densely populated or confined habitats, and is associated to a wide range of health effects. Good indoor air quality is thus vital and a prerequisite for fully confined environments such as space habitats. Bioaerosols and microbial contamination in these confined space stations can have significant health impacts, considering the unique prevailing conditions and constraints of such habitats. Therefore, biocontamination in space stations is strictly monitored and controlled to ensure crew and mission safety. However, efficient bioaerosol control measures rely on solid understanding and knowledge on how these bioaerosols are created and dispersed, and which factors affect the survivability of the associated microorganisms. Here we review the current knowledge gained from relevant studies in this wide and multidisciplinary area of bioaerosol dispersion modeling and biological indoor air quality control, specifically taking into account the specific space conditions.

Quality Control Pathways for Nucleus-Encoded Eukaryotic tRNA Biosynthesis and Subcellular Trafficking

PubMed Central

Huang, Hsiao-Yun

2015-01-01

tRNAs perform an essential role in translating the genetic code. They are long-lived RNAs that are generated via numerous posttranscriptional steps. Eukaryotic cells have evolved numerous layers of quality control mechanisms to ensure that the tRNAs are appropriately structured, processed, and modified. We describe the known tRNA quality control processes that check tRNAs and correct or destroy aberrant tRNAs. These mechanisms employ two types of exonucleases, CCA end addition, tRNA nuclear aminoacylation, and tRNA subcellular traffic. We arrange these processes in order of the steps that occur from generation of precursor tRNAs by RNA polymerase (Pol) III transcription to end maturation and modification in the nucleus to splicing and additional modifications in the cytoplasm. Finally, we discuss the tRNA retrograde pathway, which allows tRNA reimport into the nucleus for degradation or repair. PMID:25848089

Flexible solution for interoperable cloud healthcare systems.

PubMed

Vida, Mihaela Marcella; Lupşe, Oana Sorina; Stoicu-Tivadar, Lăcrămioara; Bernad, Elena

2012-01-01

It is extremely important for the healthcare domain to have a standardized communication because will improve the quality of information and in the end the resulting benefits will improve the quality of patients' life. The standards proposed to be used are: HL7 CDA and CCD. For a better access to the medical data a solution based on cloud computing (CC) is investigated. CC is a technology that supports flexibility, seamless care, and reduced costs of the medical act. To ensure interoperability between healthcare information systems a solution creating a Web Custom Control is presented. The control shows the database tables and fields used to configure the two standards. This control will facilitate the work of the medical staff and hospital administrators, because they can configure the local system easily and prepare it for communication with other systems. The resulted information will have a higher quality and will provide knowledge that will support better patient management and diagnosis.

Verification and Implementation of Operations Safety Controls for Flight Missions

NASA Technical Reports Server (NTRS)

Smalls, James R.; Jones, Cheryl L.; Carrier, Alicia S.

2010-01-01

There are several engineering disciplines, such as reliability, supportability, quality assurance, human factors, risk management, safety, etc. Safety is an extremely important engineering specialty within NASA, and the consequence involving a loss of crew is considered a catastrophic event. Safety is not difficult to achieve when properly integrated at the beginning of each space systems project/start of mission planning. The key is to ensure proper handling of safety verification throughout each flight/mission phase. Today, Safety and Mission Assurance (S&MA) operations engineers continue to conduct these flight product reviews across all open flight products. As such, these reviews help ensure that each mission is accomplished with safety requirements along with controls heavily embedded in applicable flight products. Most importantly, the S&MA operations engineers are required to look for important design and operations controls so that safety is strictly adhered to as well as reflected in the final flight product.

High-speed civil transport flight- and propulsion-control technological issues

NASA Technical Reports Server (NTRS)

Ray, J. K.; Carlin, C. M.; Lambregts, A. A.

1992-01-01

Technology advances required in the flight and propulsion control system disciplines to develop a high speed civil transport (HSCT) are identified. The mission and requirements of the transport and major flight and propulsion control technology issues are discussed. Each issue is ranked and, for each issue, a plan for technology readiness is given. Certain features are unique and dominate control system design. These features include the high temperature environment, large flexible aircraft, control-configured empennage, minimizing control margins, and high availability and excellent maintainability. The failure to resolve most high-priority issues can prevent the transport from achieving its goals. The flow-time for hardware may require stimulus, since market forces may be insufficient to ensure timely production. Flight and propulsion control technology will contribute to takeoff gross weight reduction. Similar technology advances are necessary also to ensure flight safety for the transport. The certification basis of the HSCT must be negotiated between airplane manufacturers and government regulators. Efficient, quality design of the transport will require an integrated set of design tools that support the entire engineering design team.

Quality Control of High-Dose-Rate Brachytherapy: Treatment Delivery Analysis Using Statistical Process Control

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

Able, Charles M., E-mail: cable@wfubmc.edu; Bright, Megan; Frizzell, Bart

Purpose: Statistical process control (SPC) is a quality control method used to ensure that a process is well controlled and operates with little variation. This study determined whether SPC was a viable technique for evaluating the proper operation of a high-dose-rate (HDR) brachytherapy treatment delivery system. Methods and Materials: A surrogate prostate patient was developed using Vyse ordnance gelatin. A total of 10 metal oxide semiconductor field-effect transistors (MOSFETs) were placed from prostate base to apex. Computed tomography guidance was used to accurately position the first detector in each train at the base. The plan consisted of 12 needles withmore » 129 dwell positions delivering a prescribed peripheral dose of 200 cGy. Sixteen accurate treatment trials were delivered as planned. Subsequently, a number of treatments were delivered with errors introduced, including wrong patient, wrong source calibration, wrong connection sequence, single needle displaced inferiorly 5 mm, and entire implant displaced 2 mm and 4 mm inferiorly. Two process behavior charts (PBC), an individual and a moving range chart, were developed for each dosimeter location. Results: There were 4 false positives resulting from 160 measurements from 16 accurately delivered treatments. For the inaccurately delivered treatments, the PBC indicated that measurements made at the periphery and apex (regions of high-dose gradient) were much more sensitive to treatment delivery errors. All errors introduced were correctly identified by either the individual or the moving range PBC in the apex region. Measurements at the urethra and base were less sensitive to errors. Conclusions: SPC is a viable method for assessing the quality of HDR treatment delivery. Further development is necessary to determine the most effective dose sampling, to ensure reproducible evaluation of treatment delivery accuracy.« less

Read Code Quality Assurance

PubMed Central

Schulz, Erich; Barrett, James W.; Price, Colin

1998-01-01

As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

Read Code quality assurance: from simple syntax to semantic stability.

PubMed

Schulz, E B; Barrett, J W; Price, C

1998-01-01

As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with "business rules" declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

Quality assurance for antimicrobial susceptibility testing of Neisseria gonorrhoeae in Latin American and Caribbean countries, 2013-2015.

PubMed

Sawatzky, Pam; Martin, Irene; Galarza, Patricia; Carvallo, Marıa Elena Trigoso; Araya Rodriguez, Pamela; Cruz, Olga Marina Sanabria; Hernandez, Alina Llop; Martinez, Mario Fabian; Borthagaray, Graciela; Payares, Daisy; Moreno, José E; Chiappe, Marina; Corredor, Aura Helena; Thakur, Sidharath Dev; Dillon, Jo-Anne R

2018-04-19

A Neisseria gonorrhoeae antimicrobial susceptibility quality control comparison programme was re-established in Latin America and the Caribbean to ensure antimicrobial susceptibility data produced from the region are comparable nationally and internationally. Three panels, consisting of N. gonorrhoeae isolates comprising reference strains and other characterised isolates were sent to 11 participating laboratories between 2013 and 2015. Antimicrobial susceptibilities for these isolates were determined using agar dilution, Etest or disc diffusion methods. Modal minimum inhibitory concentrations (MICs) for each panel isolate/antibiotic combination were calculated. The guidelines of the Clinical and Laboratory Standards Institute were used for interpretations of antimicrobial susceptibility. The agreement of MICs with the modal MICs was determined for each of the participating laboratories as well as for each of the antibiotics tested. Five of 11 laboratories that participated in at least one panel had an overall average agreement between participants' MIC results and modal MICs of >90%. For other laboratories, agreements ranged from 60.0% to 82.4%. The proportion of agreement between interpretations for all the antibiotics, except penicillin and tetracycline, was >90%. The percentages of agreement between MIC results and their modes for erythromycin, spectinomycin, cefixime and azithromycin were >90%. Tetracycline, ceftriaxone and ciprofloxacin agreement ranged from 84.5% to 89.1%, while penicillin had 78.8% agreement between MICs and modal MICs. The participating laboratories had acceptable results, similar to other international quality assurance programmes. It is important to ensure continuation of the International Gonococcal Antimicrobial Susceptibility Quality Control Comparison Programme to ensure that participants can identify and correct any problems in antimicrobial susceptibility testing for N. gonorrhoeae as they arise and continue to generate reproducible and reliable data. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An in-depth analysis of pharmaceutical regulation in the Republic of Moldova

PubMed Central

2014-01-01

Objective Regulation of the pharmaceutical system is a crucial, yet often neglected, component in ensuring access to safe and effective medicines. The aim of this study was to provide an in-depth analysis of the existing pharmaceutical regulation, including recent changes, in the Republic of Moldova. Methods Data from field work conducted by the World Health Organization (WHO) together with a review of policy documents and quantitative secondary data analysis was used to achieve this aim. Results This analysis identified several ways in which pharmaceutical regulation affects availability of quality medicines in the Republic of Moldova. These include lack of full implementation bioequivalence requirements for generics registration, incomplete implementation of good manufacturing practices and no implementation of good distribution practices, use of quality control instead of quality assurance as a method to ensure quality of medicines, frequent change of power within the Medicines and Medical Devices Agency (MMDA) leading to lack of long-term strategy and plans, conflict of interest between the different functions of the MMDA, the lack of sufficient funding for the MMDA to conduct its activities and to invest in continuous training of its staff (particularly inspectors) and very weak post-marketing control. Notably, several improvements have been recently introduced, including a roadmap for change for the MMDA, the introduction of good manufacturing practices and the drafting of a quality manual for the Agency. Conclusion Based on these findings the authors propose a set of priority actions to address existing gaps and draw lessons learned from other countries. PMID:25848544

Manufacturing Bms/Iso System Review

NASA Technical Reports Server (NTRS)

Gomez, Yazmin

2004-01-01

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

Factoring quality laboratory diagnosis into the malaria control agenda for sub-Saharan Africa.

PubMed

Aidoo, Michael

2013-09-01

Recent progress in malaria control in sub-Saharan Africa has been achieved primarily through provision of insecticide-treated nets, indoor residual spraying, and antimalarial drugs. Although these interventions are important, proper case identification and accurate measurement of their impact depend on quality diagnostic testing. Current availability of diagnostic testing for malaria in sub-Saharan Africa is inadequate to support disease management, prevention programs, and surveillance needs. Challenges faced include a dearth of skilled workforce, inadequate health systems infrastructure, and lack of political will. A coordinated approach to providing pre-service clinical and laboratory training together with systems that support a scale-up of laboratory services could provide means not only for effective malaria case management but also, management of non-malaria febrile illnesses, disease surveillance, and accurate control program evaluation. A synthesis of the challenges faced in ensuring quality malaria testing and how to include this information in the malaria control and elimination agenda are presented.

A Quality-Control-Oriented Database for a Mesoscale Meteorological Observation Network

NASA Astrophysics Data System (ADS)

Lussana, C.; Ranci, M.; Uboldi, F.

2012-04-01

In the operational context of a local weather service, data accessibility and quality related issues must be managed by taking into account a wide set of user needs. This work describes the structure and the operational choices made for the operational implementation of a database system storing data from highly automated observing stations, metadata and information on data quality. Lombardy's environmental protection agency, ARPA Lombardia, manages a highly automated mesoscale meteorological network. A Quality Assurance System (QAS) ensures that reliable observational information is collected and disseminated to the users. The weather unit in ARPA Lombardia, at the same time an important QAS component and an intensive data user, has developed a database specifically aimed to: 1) providing quick access to data for operational activities and 2) ensuring data quality for real-time applications, by means of an Automatic Data Quality Control (ADQC) procedure. Quantities stored in the archive include hourly aggregated observations of: precipitation amount, temperature, wind, relative humidity, pressure, global and net solar radiation. The ADQC performs several independent tests on raw data and compares their results in a decision-making procedure. An important ADQC component is the Spatial Consistency Test based on Optimal Interpolation. Interpolated and Cross-Validation analysis values are also stored in the database, providing further information to human operators and useful estimates in case of missing data. The technical solution adopted is based on a LAMP (Linux, Apache, MySQL and Php) system, constituting an open source environment suitable for both development and operational practice. The ADQC procedure itself is performed by R scripts directly interacting with the MySQL database. Users and network managers can access the database by using a set of web-based Php applications.

Astronomical Instrumentation Systems Quality Management Planning: AISQMP

NASA Astrophysics Data System (ADS)

Goldbaum, Jesse

2017-06-01

The capability of small aperture astronomical instrumentation systems (AIS) to make meaningful scientific contributions has never been better. The purpose of AIS quality management planning (AISQMP) is to ensure the quality of these contributions such that they are both valid and reliable. The first step involved with AISQMP is to specify objective quality measures not just for the AIS final product, but also for the instrumentation used in its production. The next step is to set up a process to track these measures and control for any unwanted variation. The final step is continual effort applied to reducing variation and obtaining measured values near optimal theoretical performance. This paper provides an overview of AISQMP while focusing on objective quality measures applied to astronomical imaging systems.

Astronomical Instrumentation Systems Quality Management Planning: AISQMP (Abstract)

NASA Astrophysics Data System (ADS)

Goldbaum, J.

2017-12-01

(Abstract only) The capability of small aperture astronomical instrumentation systems (AIS) to make meaningful scientific contributions has never been better. The purpose of AIS quality management planning (AISQMP) is to ensure the quality of these contributions such that they are both valid and reliable. The first step involved with AISQMP is to specify objective quality measures not just for the AIS final product, but also for the instrumentation used in its production. The next step is to set up a process to track these measures and control for any unwanted variation. The final step is continual effort applied to reducing variation and obtaining measured values near optimal theoretical performance. This paper provides an overview of AISQMP while focusing on objective quality measures applied to astronomical imaging systems.

Consumer Choice between Food Safety and Food Quality: The Case of Farm-Raised Atlantic Salmon

PubMed Central

Haghiri, Morteza

2016-01-01

Since the food incidence of polychlorinated biphenyls in farm-raised Atlantic salmon, its market demand has drastically changed as a result of consumers mistrust in both the quality and safety of the product. Policymakers have been trying to find ways to ensure consumers that farm-raised Atlantic salmon is safe. One of the suggested policies is the implementation of integrated traceability methods and quality control systems. This article examines consumer choice between food safety and food quality to purchase certified farm-raised Atlantic salmon, defined as a product that has passed through various stages of traceability systems in the province of Newfoundland and Labrador, Canada. PMID:28231118

Implementing Pay-for-Performance in the Neonatal Intensive Care Unit

PubMed Central

Profit, Jochen; Zupancic, John A. F.; Gould, Jeffrey B.; Petersen, Laura A.

2011-01-01

Pay-for-performance initiatives in medicine are proliferating rapidly. Neonatal intensive care is a likely target for these efforts because of the high cost, available databases, and relative strength of evidence for at least some measures of quality. Pay-for-performance may improve patient care but requires valid measurements of quality to ensure that financial incentives truly support superior performance. Given the existing uncertainty with respect to both the effectiveness of pay-for-performance and the state of quality measurement science, experimentation with pay-for-performance initiatives should proceed with caution and in controlled settings. In this article, we describe approaches to measuring quality and implementing pay-for-performance in the NICU setting. PMID:17473099

Information system of quality assessment for liquid and gaseous medium production

NASA Astrophysics Data System (ADS)

Bobrov, V. N.; Us, N. A.; Davidov, I. S.

2018-05-01

A method and a technical solution for controlling the quality of production of liquid and gaseous media is proposed. It is also proposed to monitor harmful factors in production while ensuring safe working conditions. Initially, using the mathematical model of an ideal atmosphere, the projection to the horizontal surface of the observation trajectory is calculated. At the second stage, the horizontal projection of the observation trajectory in real conditions is measured. The quality of the medium is judged by the difference between the projections of observation trajectories. The technical result is presented in the form of a device allowing obtaining information about the quality of the medium under investigation.

Rapid quality assessment of Radix Aconiti Preparata using direct analysis in real time mass spectrometry.

PubMed

Zhu, Hongbin; Wang, Chunyan; Qi, Yao; Song, Fengrui; Liu, Zhiqiang; Liu, Shuying

2012-11-08

This study presents a novel and rapid method to identify chemical markers for the quality control of Radix Aconiti Preparata, a world widely used traditional herbal medicine. In the method, the samples with a fast extraction procedure were analyzed using direct analysis in real time mass spectrometry (DART MS) combined with multivariate data analysis. At present, the quality assessment approach of Radix Aconiti Preparata was based on the two processing methods recorded in Chinese Pharmacopoeia for the purpose of reducing the toxicity of Radix Aconiti and ensuring its clinical therapeutic efficacy. In order to ensure the safety and effectivity in clinical use, the processing degree of Radix Aconiti should be well controlled and assessed. In the paper, hierarchical cluster analysis and principal component analysis were performed to evaluate the DART MS data of Radix Aconiti Preparata samples in different processing times. The results showed that the well processed Radix Aconiti Preparata, unqualified processed and the raw Radix Aconiti could be clustered reasonably corresponding to their constituents. The loading plot shows that the main chemical markers having the most influence on the discrimination amongst the qualified and unqualified samples were mainly some monoester diterpenoid aconitines and diester diterpenoid aconitines, i.e. benzoylmesaconine, hypaconitine, mesaconitine, neoline, benzoylhypaconine, benzoylaconine, fuziline, aconitine and 10-OH-mesaconitine. The established DART MS approach in combination with multivariate data analysis provides a very flexible and reliable method for quality assessment of toxic herbal medicine. Copyright © 2012 Elsevier B.V. All rights reserved.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Saying One Thing and Doing Another: The Paradox of Best Practices and Sex Education

ERIC Educational Resources Information Center

Oster, Maryjo M.

2008-01-01

The No Child Left Behind Act of 2001 (NCLB) specifies that all educational programs or curricula be supported by "scientifically based research" in order to ensure better quality control. However, in the arena of sex education, the federal government allocates millions of dollars in grants for schools and organizations to implement…

The clinical research triad: how can we ensure quality in out-sourced clinical trials?

PubMed

Strause, L G; Vogel, J R

1999-01-01

The importance of quality within clinical trials cannot be underestimated. Built on the foundation of patient care where quality may simply be understood and expected, the business of conducting clinical trials must evolve to instill quality and ensure that quality is maintained. How that is accomplished within the drug development process is complicated by the relationship between the vendors--the sponsor, the contractor and the investigative site. This article will discuss the dynamics of the drug development triad from the perspective of the authors. Who are the players and what is quality from each of their perspectives? Communication among all parties is essential in order to ensure that quality is maintained. Unfortunately, even with optimal communication, if expectations and goals are not clearly defined, the results may be unsatisfactory. Vision and values of each player contributes to the success of the relationship and the quality of the service.

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.

[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

PubMed

Topić, E; Turek, S

2000-01-01

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.

Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements.

PubMed

Petroczi, A; Taylor, G; Naughton, D P

2011-02-01

Dietary supplements are widely used across all ages and user groups and constitute a considerable business sector in most developed countries. Hazards relating to concentration, composition, individual contaminants and supplement interactions present an increasing public health concern. The aim of this paper is to review the literature for reported supplement contaminations (occurs in ca 25% of supplements, with anabolic steroids being the most common) and complement these findings with notifications logged in the EU's Rapid Alert System for Food and Feed (RASFF) through imports or market surveillance, typically logged for poor quality control issues. Notifications in the RASFF have steadily increased by sixfold for supplements in the past 7 years with the USA and China being the major transgressors. Finland and Italy lead in detections, mainly notifying unpermitted substances and contaminants in sexual-enhancing or weight-loss supplements. This paper highlights the paucity of enforcement. Regulating supplements as a foodstuff and not a medicine, coupled with the fact that a significant proportion of the supplement market is distributed via the Internet (hence absent from routine border control and surveillance), make ensuring and enforcing safety a very challenging task. The need for better quality control, compliance and public awareness is evident. Copyright © 2010 Elsevier Ltd. All rights reserved.

How to run a successful Journal

PubMed Central

Jawaid, Shaukat Ali; Jawaid, Masood

2017-01-01

Publishing and successfully running a good quality peer reviewed biomedical scientific journal is not an easy task. Some of the pre-requisites include a competent experienced editor supported by a team. Long term sustainability of a journal will depend on good quality manuscripts, active editorial board, good quality of reviewers, workable business model to ensure financial support, increased visibility which will ensure increased submissions, indexation in various important databases, online availability and easy to use website. This manuscript outlines the logistics and technical issues which need to be resolved before starting a new journal and ensuring sustainability of a good quality peer reviewed journal. PMID:29492089

Quantifying the effect of air quality control measures during the 2010 Commonwealth Games at Delhi, India

NASA Astrophysics Data System (ADS)

Beig, Gufran; Chate, Dilip M.; Ghude, Sachin. D.; Mahajan, A. S.; Srinivas, R.; Ali, K.; Sahu, S. K.; Parkhi, N.; Surendran, D.; Trimbake, H. R.

2013-12-01

In 2010, the XIX Commonwealth Games (CWG-2010) were held in India for the first time at Delhi and involved 71 commonwealth nations and dependencies with more than 6000 athletes participating in 272 events. This was the largest international multi-sport event to be staged in India and strict emission controls were imposed during the games in order to ensure improved air quality for the participating athletes as a significant portion of the population in Delhi is regularly exposed to elevated levels of pollution. The air quality control measures ranged from vehicular and traffic controls to relocation of factories and reduction of power plant emissions. In order to understand the effects of these policy induced control measures, a network of air quality and weather monitoring stations was set-up across different areas in Delhi under the Government of India's System of Air quality Forecasting And Research (SAFAR) project. Simultaneous measurements of aerosols, reactive trace gases (e.g. NOx, O3, CO) and meteorological parameters were made before, during and after CWG-2010. Contrary to expectations, the emission controls implemented were not sufficient to reduce the pollutants, instead in some cases, causing an increase. The measured pollutants regularly exceeded the National Ambient Air Quality limits over the games period. The reasons for this increase are attributed to an underestimation of the required control measures, which resulted in inadequate planning. The results indicate that any future air quality control measures need to be well planned and strictly imposed in order to improve the air quality in Delhi, which affects a large population and is deteriorating rapidly. Thus, the presence of systematic high resolution data and realistic emission inventories through networks such as SAFAR will be directly useful for the future.

Ensuring Quality Nursing Home Care

MedlinePlus

Ensuring Quality Nursing Home Care Before you choose a nursing home Expert information from Healthcare Professionals Who Specialize in the Care ... Nearly 1.6 million older Americans live in nursing homes in the United States. The move to ...

[Study on the optimization of monitoring indicators of drinking water quality during health supervision].

PubMed

Ye, Bixiong; E, Xueli; Zhang, Lan

2015-01-01

To optimize non-regular drinking water quality indices (except Giardia and Cryptosporidium) of urban drinking water. Several methods including drinking water quality exceed the standard, the risk of exceeding standard, the frequency of detecting concentrations below the detection limit, water quality comprehensive index evaluation method, and attribute reduction algorithm of rough set theory were applied, redundancy factor of water quality indicators were eliminated, control factors that play a leading role in drinking water safety were found. Optimization results showed in 62 unconventional water quality monitoring indicators of urban drinking water, 42 water quality indicators could be optimized reduction by comprehensively evaluation combined with attribute reduction of rough set. Optimization of the water quality monitoring indicators and reduction of monitoring indicators and monitoring frequency could ensure the safety of drinking water quality while lowering monitoring costs and reducing monitoring pressure of the sanitation supervision departments.

Combat Ration Advanced Manufacturing Technology Demonstration (CRAMTD). ’Generic Inspection-Statistical Process Control System for a Combat Ration Manufacturing Facility’. Short Term Project (STP) Number 3.

DTIC Science & Technology

1996-01-01

failure as due to an adhesive layer between the foil and inner polypropylene layers. "* Under subcontract, NFPA provided HACCP draft manuals for the...parameters of the production process and to ensure that they are within their target values. In addition, a HACCP program was used to assure product...played an important part in implementing Hazard Analysis Critical Control Points ( HACCP ) as part of the Process and Quality Control manual. The National

ACT-Vision: active collaborative tracking for multiple PTZ cameras

NASA Astrophysics Data System (ADS)

Broaddus, Christopher; Germano, Thomas; Vandervalk, Nicholas; Divakaran, Ajay; Wu, Shunguang; Sawhney, Harpreet

2009-04-01

We describe a novel scalable approach for the management of a large number of Pan-Tilt-Zoom (PTZ) cameras deployed outdoors for persistent tracking of humans and vehicles, without resorting to the large fields of view of associated static cameras. Our system, Active Collaborative Tracking - Vision (ACT-Vision), is essentially a real-time operating system that can control hundreds of PTZ cameras to ensure uninterrupted tracking of target objects while maintaining image quality and coverage of all targets using a minimal number of sensors. The system ensures the visibility of targets between PTZ cameras by using criteria such as distance from sensor and occlusion.

Ensuring Food Security Through Enhancing Microbiological Food Safety

NASA Astrophysics Data System (ADS)

Mikš-Krajnik, Marta; Yuk, Hyun-Gyun; Kumar, Amit; Yang, Yishan; Zheng, Qianwang; Kim, Min-Jeong; Ghate, Vinayak; Yuan, Wenqian; Pang, Xinyi

2015-10-01

Food safety and food security are interrelated concepts with a profound impact on the quality of human life. Food security describes the overall availability of food at different levels from global to individual household. While, food safety focuses on handling, preparation and storage of foods in order to prevent foodborne illnesses. This review focuses on innovative thermal and non-thermal technologies in the area of food processing as the means to ensure food security through improving food safety with emphasis on the reduction and control of microbiological risks. The antimicrobial efficiency and mechanism of new technologies to extend the shelf life of food product were also discussed.

Process analytical technologies (PAT) in freeze-drying of parenteral products.

PubMed

Patel, Sajal Manubhai; Pikal, Michael

2009-01-01

Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes. This review provides a comprehensive list of process monitoring devices that can be used to monitor critical process parameters and will focus on a critical review of the viability of the PAT schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with particular emphasis on batch techniques that can be used on all the dryers independent of the dryer scale.

Advance in quality assessment of Chinese materia medica using microscopic and morphological methods.

PubMed

Miao, Xiao-Su; Cui, Qing-Yu; Wang, Zhao-Yi; Liu, Xiao-Na; Zhao, An-Bang; Qiao, Yan-Jiang; Wu, Zhi-Sheng

2017-09-01

Quality evaluation plays a vital role in ensuring safety and effectiveness of Chinese materia medica (CMM). Microscopic and morphological technologies can be used to distinguish CMM's characteristics, such as shape, size, texture, section, and smell, for authenticity and quality control of CMM. The microscopic and morphological applications of novel micro-technology, colorimeter, and texture analyzer for CMM identification are summarized and the future prospect is discussed in this paper. Various styles and complex sources of CMM are systemically reviewed, including cormophyte medicinal materials, fruit and seeds, pollen grain, and spore materials. Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

Ultrasonically Assisted Cutting of Bio-tissues in Microtomy

NASA Astrophysics Data System (ADS)

Wang, Dong; Roy, Anish; Silberschmidt, Vadim V.

Modern-day histology of bio-tissues for supporting stratified medicine diagnoses requires high-precision cutting to ensure high quality extremely thin specimens used in analysis. Additionally, the cutting quality is significantly affected by a wide variety of soft and hard tissues in the samples. This paper deals with development of a next generation of microtome employing introduction of controlled ultrasonic vibration to realise a hybrid cutting process of bio-tissues. The study is based on a combination of advanced experimental and numerical (finite-element) studies of multi-body dynamics of a cutting system. The quality of cut samples produced with the prototype is compared with the state-of-the-art.

[Air quality control systems: heating, ventilating, and air conditioning (HVAC)].

PubMed

Bellucci Sessa, R; Riccio, G

2004-01-01

After a brief illustration of the principal layout schemes of Heating, Ventilating, and Air Conditioning (HVAC), the first part of this paper summarizes the standards, both voluntary and compulsory, regulating HVAC facilities design and installation with regard to the question of Indoor Air Quality (IAQ). The paper then examines the problem of ventilation systems maintenance and the essential hygienistic requirements in whose absence HVAC facilities may become a risk factor for people working or living in the building. Lastly, the paper deals with HVAC design strategies and methods, which aim not only to satisfy comfort and air quality requirements, but also to ensure easy and effective maintenance procedures.

Quality by design case study: an integrated multivariate approach to drug product and process development.

PubMed

Huang, Jun; Kaul, Goldi; Cai, Chunsheng; Chatlapalli, Ramarao; Hernandez-Abad, Pedro; Ghosh, Krishnendu; Nagi, Arwinder

2009-12-01

To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Two types of analyses were performed to extract maximal information, DOE effect & response surface analysis and multivariate analysis (PCA and PLS). The DOE effect analysis was used to evaluate the interactions and effects of three design factors (water amount, wet massing time and lubrication time), on response variables (blend flow, compressibility and tablet dissolution). The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development.

The Value of clean water: The public's willingness to pay for boatable, fishable, and swimmable quality water

NASA Astrophysics Data System (ADS)

Carson, Richard T.; Mitchell, Robert Cameron

1993-07-01

This paper presents the findings of a study designed to determine the national benefits of freshwater pollution control. By using data from a national contingent valuation survey, we estimate the aggregate benefits of meeting the goals of the Clean Water Act. A valuation function is estimated which depicts willingness to pay as a function of water quality, income, and other variables. Several validation checks and tests for specific biases are performed, and the benefit estimates are corrected for missing and invalid responses. The two major policy implications from our work are that the benefits and costs of water pollution control efforts are roughly equal and that many of the new policy actions necessary to ensure that all water bodies reach at least a swimmable quality level will not have positive net benefits.

[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

PubMed

Giannoli, Jean-Marc; Szymanowicz, Anton

2011-01-01

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.

Choice of mathematical models for technological process of glass rod drawing

NASA Astrophysics Data System (ADS)

Alekseeva, L. B.

2017-10-01

The technological process of drawing glass rods (light guides) is considered. Automated control of the drawing process is reduced to the process of making decisions to ensure a given quality. The drawing process is considered as a control object, including the drawing device (control device) and the optical fiber forming zone (control object). To study the processes occurring in the formation zone, mathematical models are proposed, based on the continuum mechanics basics. To assess the influence of disturbances, a transfer function is obtained from the basis of the wave equation. Obtaining the regression equation also adequately describes the drawing process.

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

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

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

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

Electron tubes for industrial applications

NASA Astrophysics Data System (ADS)

Gellert, Bernd

1994-05-01

This report reviews research and development efforts within the last years for vacuum electron tubes, in particular power grid tubes for industrial applications. Physical and chemical effects are discussed that determine the performance of todays devices. Due to the progress made in the fundamental understanding of materials and newly developed processes the reliability and reproducibility of power grid tubes could be improved considerably. Modern computer controlled manufacturing methods ensure a high reproducibility of production and continuous quality certification according to ISO 9001 guarantees future high quality standards. Some typical applications of these tubes are given as an example.

The postoperative handover: a focus group interview study with nurse anaesthetists, anaesthesiologists and PACU nurses.

PubMed

Randmaa, Maria; Engström, Maria; Swenne, Christine Leo; Mårtensson, Gunilla

2017-08-04

To investigate different professionals' (nurse anaesthetists', anaesthesiologists', and postanaesthesia care unit nurses') descriptions of and reflections on the postoperative handover. A focus group interview study with a descriptive design using qualitative content analysis of transcripts. One anaesthetic clinic at two hospitals in Sweden. Six focus groups with 23 healthcare professionals involved in postoperative handovers. Each group was homogeneous regarding participant profession, resulting in two groups per profession: nurse anaesthetists (n=8), anaesthesiologists (n=7) and postanaesthesia care unit nurses (n=8). Patterns and five categories emerged: (1) having different temporal foci during handover, (2) insecurity when information is transferred from one team to another, (3) striving to ensure quality of the handover, (4) weighing the advantages and disadvantages of the bedside handover and (5) having different perspectives on the transfer of responsibility. The professionals' perceptions of the postoperative handover differed with regard to temporal foci and transfer of responsibility. All professional groups were insecure about having all information needed to ensure the quality of care. They strived to ensure quality of the handover by: focusing on matters that deviated from the normal course of events, aiding memory through structure and written information and cooperating within and between teams. They reported that the bedside handover enhances their control of the patient but also that it could threaten the patient's privacy and that frequent interruptions could be disturbing. The present findings revealed variations in different professionals' views on the postoperative handover. Healthcare interventions are needed to minimise the gap between professionals' perceptions and practices and to achieve a shared understanding of postoperative handover. Furthermore, to ensure high-quality and safe care, stakeholders/decision makers need to pay attention to the environment and infrastructure in postanaesthesia care. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Social medicine and healthcare economics. The framework for future forms of healthcare].

PubMed

Rebscher, Herbert

2008-05-01

In the political debate, even in academia, the concepts of "profitability" or "efficiency" are thrown around very robustly and freely with no regard for the players themselves. Economically speaking there can be no efficiency without a definition of targets in terms of outcomes and their level of quality. If even the government's Council of Economic Experts itself finds in its assessment of hospital funding that the "reform's target parameters - improving the profitability of service provision - have developed positively", but adds that "whether this also applies to the quality of services provided or to the realisation of healthcare outcomes remains to be seen due to the lack of evidence" [21], this indicates a one-sided and problematic curtailment of the concept even by highly competent bodies. Economic control of new forms of healthcare by means of prices and fees for clearly defined services is a complex problem that has not been dealt with adequately. All pricing is based on classification models aimed at ensuring cost and benefit clusters that are as homogeneous as possible. Classification models in healthcare as a basis for price control targets need constant adjusting to ensure accuracy of mapping and appropriateness to performance. A prerequisite for the methodology behind price control models of this kind is presupposing a responsible, rule-bound and criteria-based handling of "variance" and "coincidence" by means of risk-adjusted quality and price systems. They will define the character of a wide range of steering tools and have an effect that goes beyond the narrow formal confines of the sector. That is why the regulatory framework will need first and foremost to define a qualitative framework for the political "security infrastructure" by means of deregulated economic processes in which price control becomes accountable and is justified in terms of content.

Personalization in the health care system: do personal health budgets have an impact on outcomes and cost?

PubMed

Jones, Karen; Forder, Julien; Caiels, James; Welch, Elizabeth; Glendinning, Caroline; Windle, Karen

2013-10-01

In England's National Health Service, personal health budgets are part of a growing trend to give patients more choice and control over how health care services are managed and delivered. The personal health budget programme was launched by the Department of Health in 2009, and a three-year independent evaluation was commissioned with the aim of identifying whether the initiative ensured better health- and care-related outcomes and at what cost when compared to conventional service delivery. The evaluation used a pragmatic controlled trial design to compare the outcomes and costs of patients selected to receive a personal health budget with those continuing with conventional support arrangements (control group). Just over 1000 individuals were recruited into the personal health budget group and 1000 into the control group in order to ensure sufficient statistical power, and followed for 12 months. The use of personal health budgets was associated with significant improvement in patients' care-related quality of life and psychological wellbeing at 12 months. Personal health budgets did not appear to have an impact on health status, mortality rates, health-related quality of life or costs over the same period. With net benefits measured in terms of care-related quality of life on the adult social care outcome toolkit measure, personal health budgets were cost-effective: that is, budget holders experienced greater benefits than people receiving conventional services, and the budgets were worth the cost. The evaluation provides support for the planned wider roll-out of personal health budgets in the English NHS after 2014 in so far as the localities in the pilot sample are representative of the whole country.

Challenges in Special Steel Making

NASA Astrophysics Data System (ADS)

Balachandran, G.

2018-02-01

Special bar quality [SBQ] is a long steel product where an assured quality is delivered by the steel mill to its customer. The bars have enhanced tolerance to higher stress application and it is demanded for specialised component making. The SBQ bars are sought for component making processing units such as closed die hot forging, hot extrusion, cold forging, machining, heat treatment, welding operations. The final component quality of the secondary processing units depends on the quality maintained at the steel maker end along with quality maintained at the fabricator end. Thus, quality control is ensured at every unit process stages. The various market segments catered to by SBQ steel segment is ever growing and is reviewed. Steel mills need adequate infrastructure and technological capability to make these higher quality steels. Some of the critical stages of processing SBQ and the critical quality maintenance parameters at the steel mill in the manufacture has been brought out.

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.

A Process Analytical Technology (PAT) approach to control a new API manufacturing process: development, validation and implementation.

PubMed

Schaefer, Cédric; Clicq, David; Lecomte, Clémence; Merschaert, Alain; Norrant, Edith; Fotiadu, Frédéric

2014-03-01

Pharmaceutical companies are progressively adopting and introducing Process Analytical Technology (PAT) and Quality-by-Design (QbD) concepts promoted by the regulatory agencies, aiming the building of the quality directly into the product by combining thorough scientific understanding and quality risk management. An analytical method based on near infrared (NIR) spectroscopy was developed as a PAT tool to control on-line an API (active pharmaceutical ingredient) manufacturing crystallization step during which the API and residual solvent contents need to be precisely determined to reach the predefined seeding point. An original methodology based on the QbD principles was designed to conduct the development and validation of the NIR method and to ensure that it is fitted for its intended use. On this basis, Partial least squares (PLS) models were developed and optimized using chemometrics methods. The method was fully validated according to the ICH Q2(R1) guideline and using the accuracy profile approach. The dosing ranges were evaluated to 9.0-12.0% w/w for the API and 0.18-1.50% w/w for the residual methanol. As by nature the variability of the sampling method and the reference method are included in the variability obtained for the NIR method during the validation phase, a real-time process monitoring exercise was performed to prove its fit for purpose. The implementation of this in-process control (IPC) method on the industrial plant from the launch of the new API synthesis process will enable automatic control of the final crystallization step in order to ensure a predefined quality level of the API. In addition, several valuable benefits are expected including reduction of the process time, suppression of a rather difficult sampling and tedious off-line analyses. © 2013 Published by Elsevier B.V.

[Analysis of the results of the SEIMC External Quality Control Program for HIV-1 and HCV viral loads. Year 2008].

PubMed

Mira, Nieves Orta; Serrano, María del Remedio Guna; Martínez, José Carlos Latorre; Ovies, María Rosario; Pérez, José L; Cardona, Concepción Gimeno

2010-01-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2008 SEIMC External Quality Control Program for HIV-1 and HCV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from 3 different viremic patients, in the range of 2-5 log(10) copies/mL; two of these standards were identical aiming to determine repeatability. The specificity was complete for all commercial methods, and no false positive results were reported by the participants. A significant proportion of the laboratories (24% on average) obtained values out of the accepted range (mean +/- 0.2 log(10) copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (D < 0.5 log(10) copias/mL). The HCV program consisted of two standards with different viral load contents. Most of the participants (88,7%) obtained results within the accepted range (mean +/- 1.96 SD log(10) UI/mL). Post-analytical errors due to mistranscription of the results were detected for HCV, but not for the HIV-1 program. Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. 2010 Elsevier España S.L. All rights reserved.

[Establishment of biological assess for quality control of Fuzi based on determination of premature ventricular contractions in rats].

PubMed

Zhao, Zhi-Hao; Zhang, Ding-Kun; Wu, Ming-Quan; Li, Chun-Yu; Cao, Li-Juan; Zhang, Ping; Liu, Cui-Zhe; Wang, Jia-Bo; Xiao, Xiao-He

2016-10-01

Aconiti Lateralis Radix (Fuzi) is a toxic traditional Chinese medicine with definite efficacy. In order to improve the quality control of its different prepared products and ensure the security in clinic, it is significant to establish a method of quality evaluation related to clinic adverse effects. Aiming at the important biological marker of early cardiac toxicity reaction, there was no method to detect it. In this manuscript, a novel approach for measuring the minimal toxic dose (MTD) of premature ventricular contractions (PVC) poisoning of rats was established. Then, the determination methodology and conditions were optimized to meet the needs of the quality and biological assessment, including animal sex, weight, stability of standards and test solutions. Using this method, the MTD value of different Fuzi products were determined, such as Heishunpian, Baifupian, Zhengfupian, Baofupian, and Paotianxiong. The results showed that the MTD of Fuzi was significantly decreased after detoxification processed (P<0.05) and the MTD of Heishunpian, Zhengfupian, Baofupian and Baifupian was as much as 15.76, 22.36, 19.65 and 20.97 times to that of unprocessed Shengfuzi. In addition, Paotianxiong could not induce PVC in rats, which indicated that Paotianxiong was nontoxic and safe.This method could appropriately reflects the cardiotoxity of Fuzi and its prepared samples. Together with the chemical composition analysis, the contents of diester alkaloids were explored including aconitine, mesaconitine and hypaconitine as well as monoester alkaloids in Fuzi and its prepared products were significantly associated with PVC. Furthermore, there may be some components undetermined facilitating arrhythmia to be worth exploring. This research provides an overall and comprehensive approach to diagnose early clinical cardiotoxity and control the quality of Fuzi, which could not only be a complementary solution for the chemical evaluation, but a new method to ensure its efficacy and security of clinical application. Copyright© by the Chinese Pharmaceutical Association.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2013].

PubMed

Orta Mira, Nieves; Del Remedio Guna Serrano, María; Latorre Martínez, José-Carlos; Medina González, Rafael; Rosario Ovies, María; Poveda, Marta; Ruiz de Gopegui, Enrique; Gimeno Cardona, Concepción

2015-07-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2013 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (25% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 78% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2014].

PubMed

Medina González, Rafael; Orta Mira, Nieves; Guna Serrano, María Del Remedio; Latorre Martínez, José-Carlos; Gopegui, Enrique Ruiz de; Rosario Ovies, María; Poveda, Marta; Gimeno Cardona, Concepción

2016-07-01

Human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarizes the results obtained from the 2014 SEIMC (Spanish Society of Infectious Diseases and Clinical Microbiology) External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of 5 standards were sent. One standard consisted in seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL; 2 of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (30.8% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 95.8% of laboratories reporting results within the limits (Δ < 0.5 log10 copies/mL). The HBV and HCV program consisted of 2 standards with different viral load contents. Most of the participants, 83.7% in the case of HCV and 87.9% in the HBV, obtained all the results within the accepted range (mean ± 1.96 standard deviations log10 IU/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

Strategies for ensuring quality data from Indian investigational sites

PubMed Central

Hajos, Antal K.; Kamble, Sujal K.

2011-01-01

The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning. PMID:21731855

Report: EPA Needs to Fulfill Its Designated Responsibilities to Ensure Effective BioWatch Program

EPA Pesticide Factsheets

Report #2005-P-00012, March 23, 2005. EPA did not provide adequate oversight of the sampling operations to ensure quality assurance guidance was adhered to, potentially affecting the quality of the samples taken.

Quality Control Review of the Dixon Hughes Goodman LLP FY 2014 Single Audit of Logistics Management Institute

DTIC Science & Technology

2016-09-29

independent, relevant, and timely oversight of the Department of Defense that supports the warfighter; promotes accountability , integrity, and...compliance testing for the allowable costs/cost principles compliance requirement to ensure the review of indirect costs is adequately performed...consulting services in logistics, acquisition and financial management, infrastructure management, information management, organizational improvement, and

Use of a Motivational Interviewing-Informed Strategy in Group Orientations to Improve Retention and Intervention Attendance in a Randomized Controlled Trial

ERIC Educational Resources Information Center

Xiao, Lan; Lv, Nan; Rosas, Lisa G.; Karve, Shweta; Luna, Veronica; Jameiro, Elizabeth; Wittels, Nancy; Ma, Jun

2016-01-01

High retention and treatment adherence are essential to ensure the quality of evidence from clinical trials. Strategies for improving these have been explored but actual rates in lifestyle intervention trials indicate challenges. This study examined the use of a motivational interviewing-informed strategy during interactive group orientations…

Inter-laboratory validation of an inexpensive streamlined method to measure inorganic arsenic in rice grain

USDA-ARS?s Scientific Manuscript database

With the establishment by CODEX of a 200 ng/g limit of inorganic arsenic (iAs) in polished rice grain, more analyses of iAs will be necessary to ensure compliance in regulatory and trade applications, to assess quality control in commercial rice production, and to conduct research involving iAs in r...

Use limits in wilderness: Assumptions and gaps in knowledge

Treesearch

Troy E. Hall

2001-01-01

As wilderness use levels have changed, managers have often considered implementation of use limits to control the impacts of use density. Use limits are generally intended to protect natural qualities and/or to ensure opportunities for solitude, although the second goal appears to have become more common over time, and may be the central use-related concern for certain...

Chemical analysis of Panax quinquefolius (North American ginseng): A review.

PubMed

Wang, Yaping; Choi, Hyung-Kyoon; Brinckmann, Josef A; Jiang, Xue; Huang, Linfang

2015-12-24

Panax quinquefolius (PQ) is one of the best-selling natural health products due to its proposed beneficial anti-aging, anti-cancer, anti-stress, anti-fatigue, and anxiolytic effects. In recent years, the quality of PQ has received considerable attention. Sensitive and accurate methods for qualitative and quantitative analyses of chemical constituents are necessary for the comprehensive quality control to ensure the safety and efficacy of PQ. This article reviews recent progress in the chemical analysis of PQ and its preparations. Numerous analytical techniques, including spectroscopy, thin-layer chromatography (TLC), gas chromatography (GC), high-performance liquid chromatography (HPLC), liquid chromatography/mass spectrometry (LC/MS), high-speed centrifugal partition chromatography (HSCPC), high-performance counter-current chromatography (HPCCC), nuclear magnetic resonance spectroscopy (NMR), and immunoassay, are described. Among these techniques, HPLC coupled with mass spectrometry (MS) is the most promising method for quality control. The challenges encountered in the chemical analysis of PQ are also briefly discussed, and the remaining questions regarding the quality control of PQ that require further investigation are highlighted. Copyright © 2015 Elsevier B.V. All rights reserved.

[The influence of attention-deficit hyperactivity disorder on quality of life: case reports].

PubMed

Dallos, Gyöngyvér; Balázs, Judit

2014-06-01

Recently the concept of Quality of Life has gained increasing importance in Psychiatry. Studies focusing on how much attention-deficit hyperactivity disorder (ADHD) - one of the most prevalent psychiatric disorders among children - affects the every day life found that children with ADHD had significantly lower Quality of Life than healthy controls or children with other psychiatric or physical disorders. In the current paper we present the case of two boys with ADHD and their families. These cases demonstrate that adequate treatment of the symptoms of ADHD can improve Quality of Life of the patients and their families, moreover, different life events can worsen the symptoms of ADHD. Professionals should ensure flexible treatment, which conforms to the above described processes.

Quality Assurance in Stem Cell Banking: Emphasis on Embryonic and Induced Pluripotent Stem Cell Banking.

PubMed

Kallur, Therése; Blomberg, Pontus; Stenfelt, Sonya; Tryggvason, Kristian; Hovatta, Outi

2017-01-01

For quality assurance (QA) in stem cell banking, a planned system is needed to ensure that the banked products, stem cells, meet the standards required for research, clinical use, and commercial biotechnological applications. QA is process oriented, avoids, or minimizes unacceptable product defects, and particularly encompasses the management and operational systems of the bank, as well as the ethical and legal frameworks. Quality control (QC ) is product oriented and therefore ensures the stem cells of a bank are what they are expected to be. Testing is for controlling, not assuring, product quality, and is therefore a part of QC , not QA. Like QA, QC is essential for banking cells for quality research and translational application (Schwartz et al., Lancet 379:713-720, 2012). Human embryonic stem cells (hESCs), as cells derived from donated supernumerary embryos from in vitro fertilization (IVF) therapy, are different from other stem cell types in resulting from an embryo that has had two donors . This imposes important ethical and legal constraints on the utility of the cells, which, together with quite specific culture conditions, require special attention in the QA system. Importantly, although the origin and derivation of induced pluripotent stem cells (iPSCs ) differ from that of hESCs, many of the principles of QA for hESC banking are applicable to iPSC banking (Stacey et al., Cell Stem Cell 13:385-388, 2013). Furthermore, despite differences between the legal and regulatory frameworks for hESC and iPSC banking between different countries, the requirements for QA are being harmonized (Stacey et al., Cell Stem Cell 13:385-388, 2013; International Stem Cell Banking Initiative, Stem Cell Rev 5:301-314, 2009).

Fine-grained Database Field Search Using Attribute-Based Encryption for E-Healthcare Clouds.

PubMed

Guo, Cheng; Zhuang, Ruhan; Jie, Yingmo; Ren, Yizhi; Wu, Ting; Choo, Kim-Kwang Raymond

2016-11-01

An effectively designed e-healthcare system can significantly enhance the quality of access and experience of healthcare users, including facilitating medical and healthcare providers in ensuring a smooth delivery of services. Ensuring the security of patients' electronic health records (EHRs) in the e-healthcare system is an active research area. EHRs may be outsourced to a third-party, such as a community healthcare cloud service provider for storage due to cost-saving measures. Generally, encrypting the EHRs when they are stored in the system (i.e. data-at-rest) or prior to outsourcing the data is used to ensure data confidentiality. Searchable encryption (SE) scheme is a promising technique that can ensure the protection of private information without compromising on performance. In this paper, we propose a novel framework for controlling access to EHRs stored in semi-trusted cloud servers (e.g. a private cloud or a community cloud). To achieve fine-grained access control for EHRs, we leverage the ciphertext-policy attribute-based encryption (CP-ABE) technique to encrypt tables published by hospitals, including patients' EHRs, and the table is stored in the database with the primary key being the patient's unique identity. Our framework can enable different users with different privileges to search on different database fields. Differ from previous attempts to secure outsourcing of data, we emphasize the control of the searches of the fields within the database. We demonstrate the utility of the scheme by evaluating the scheme using datasets from the University of California, Irvine.

World Ocean Database and the Global Temperature and Salinity Profile Program Database: Synthesis of historical and near real-time ocean profile data

NASA Astrophysics Data System (ADS)

Boyer, T.; Sun, L.; Locarnini, R. A.; Mishonov, A. V.; Hall, N.; Ouellet, M.

2016-02-01

The World Ocean Database (WOD) contains systematically quality controlled historical and recent ocean profile data (temperature, salinity, oxygen, nutrients, carbon cycle variables, biological variables) ranging from Captain Cooks second voyage (1773) to this year's Argo floats. The US National Centers for Environmental Information (NCEI) also hosts the Global Temperature and Salinity Profile Program (GTSPP) Continuously Managed Database (CMD) which provides quality controlled near-real time ocean profile data and higher level quality controlled temperature and salinity profiles from 1990 to present. Both databases are used extensively for ocean and climate studies. Synchronization of these two databases will allow easier access and use of comprehensive regional and global ocean profile data sets for ocean and climate studies. Synchronizing consists of two distinct phases: 1) a retrospective comparison of data in WOD and GTSPP to ensure that the most comprehensive and highest quality data set is available to researchers without the need to individually combine and contrast the two datasets and 2) web services to allow the constantly accruing near-real time data in the GTSPP CMD and the continuous addition and quality control of historical data in WOD to be made available to researchers together, seamlessly.

[Effect of manual cleaning and machine cleaning for dental handpiece].

PubMed

Zhou, Xiaoli; Huang, Hao; He, Xiaoyan; Chen, Hui; Zhou, Xiaoying

2013-08-01

Comparing the dental handpiece' s cleaning effect between manual cleaning and machine cleaning. Eighty same contaminated dental handpieces were randomly divided into experimental group and control group, each group contains 40 pieces. The experimental group was treated by full automatic washing machine, and the control group was cleaned manually. The cleaning method was conducted according to the operations process standard, then ATP bioluminescence was used to test the cleaning results. Average relative light units (RLU) by ATP bioluminescence detection were as follows: Experimental group was 9, control group was 41. The two groups were less than the recommended RLU value provided by the instrument manufacturer (RLU < or = 45). There was significant difference between the two groups (P < 0.05). The cleaning quality of the experimental group was better than that of control group. It is recommended that the central sterile supply department should clean dental handpieces by machine to ensure the cleaning effect and maintain the quality.

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

Quality control for the first large areas of triple-GEM chambers for the CMS endcaps

NASA Astrophysics Data System (ADS)

Abbaneo, D.; Abbas, M.; Abbrescia, M.; Abi Akl, M.; Aboamer, O.; Acosta, D.; Ahmad, A.; Ahmed, W.; Aleksandrov, A.; Altieri, P.; Asawatangtrakuldee, C.; Aspell, P.; Assran, Y.; Awan, I.; Bally, S.; Ban, Y.; Banerjee, S.; Barashko, V.; Barria, P.; Bencze, G.; Beni, N.; Benussi, L.; Bhopatkar, V.; Bianco, S.; Bos, J.; Bouhali, O.; Braghieri, A.; Braibant, S.; Buontempo, S.; Calabria, C.; Caponero, M.; Caputo, C.; Cassese, F.; Castaneda, A.; Cauwenbergh, S.; Cavallo, F. R.; Celik, A.; Choi, M.; Choi, S.; Christiansen, J.; Cimmino, A.; Colafranceschi, S.; Colaleo, A.; Conde Garcia, A.; Czellar, S.; Dabrowski, M. M.; De Lentdecker, G.; De Oliveira, R.; de Robertis, G.; Dildick, S.; Dorney, B.; Endroczi, G.; Errico, F.; Fenyvesi, A.; Ferry, S.; Furic, I.; Giacomelli, P.; Gilmore, J.; Golovtsov, V.; Guiducci, L.; Guilloux, F.; Gutierrez, A.; Hadjiiska, R. M.; Hauser, J.; Hoepfner, K.; Hohlmann, M.; Hoorani, H.; Iaydjiev, P.; Jeng, Y. G.; Kamon, T.; Karchin, P.; Korytov, A.; Krutelyov, S.; Kumar, A.; Kim, H.; Lee, J.; Lenzi, T.; Litov, L.; Loddo, F.; Madorsky, A.; Maerschalk, T.; Maggi, M.; Magnani, A.; Mal, P. K.; Mandal, K.; Marchioro, A.; Marinov, A.; Majumdar, N.; Merlin, J. A.; Mitselmakher, G.; Mohanty, A. K.; Mohapatra, A.; Molnar, J.; Muhammad, S.; Mukhopadhyay, S.; Naimuddin, M.; Nuzzo, S.; Oliveri, E.; Pant, L. M.; Paolucci, P.; Park, I.; Passeggio, G.; Pavlov, B.; Philipps, B.; Piccolo, D.; Postema, H.; Puig Baranac, A.; Radi, A.; Radogna, R.; Raffone, G.; Ranieri, A.; Rashevski, G.; Riccardi, C.; Rodozov, M.; Rodrigues, A.; Ropelewski, L.; RoyChowdhury, S.; Ryu, G.; Ryu, M. S.; Safonov, A.; Salva, S.; Saviano, G.; Sharma, A.; Sharma, A.; Sharma, R.; Shah, A. H.; Shopova, M.; Sturdy, J.; Sultanov, G.; Swain, S. K.; Szillasi, Z.; Talvitie, J.; Tatarinov, A.; Tuuva, T.; Tytgat, M.; Vai, I.; Van Stenis, M.; Venditti, R.; Verhagen, E.; Verwilligen, P.; Vitulo, P.; Volkov, S.; Vorobyev, A.; Wang, D.; Wang, M.; Yang, U.; Yang, Y.; Yonamine, R.; Zaganidis, N.; Zenoni, F.; Zhang, A.

2018-02-01

The CMS Collaboration plans to equip the very forward muon system with triple-GEM detectors that can withstand the environment of the High-Luminosity LHC. This project is at the final stages of R&D and moving to production. An unprecedented large area of several 100 m2 are to be instrumented with GEM detectors which will be produced in six different sites around the world. A common construction and quality control procedure is required to ensure the performance of each detector. The quality control steps will include optical inspection, cleaning and baking of all materials and parts used to build the detector, leakage current tests of the GEM foils, high voltage tests, gas leak tests of the chambers and monitoring pressure drop vs. time, gain calibration to know the optimal operation region of the detector, gain uniformity tests, and studying the efficiency, noise and tracking performance of the detectors in a cosmic stand using scintillators.

Multi-component determination and chemometric analysis of Paris polyphylla by ultra high performance liquid chromatography with photodiode array detection.

PubMed

Chen, Pei; Jin, Hong-Yu; Sun, Lei; Ma, Shuang-Cheng

2016-09-01

Multi-source analysis of traditional Chinese medicine is key to ensuring its safety and efficacy. Compared with traditional experimental differentiation, chemometric analysis is a simpler strategy to identify traditional Chinese medicines. Multi-component analysis plays an increasingly vital role in the quality control of traditional Chinese medicines. A novel strategy, based on chemometric analysis and quantitative analysis of multiple components, was proposed to easily and effectively control the quality of traditional Chinese medicines such as Chonglou. Ultra high performance liquid chromatography was more convenient and efficient. Five species of Chonglou were distinguished by chemometric analysis and nine saponins, including Chonglou saponins I, II, V, VI, VII, D, and H, as well as dioscin and gracillin, were determined in 18 min. The method is feasible and credible, and enables to improve quality control of traditional Chinese medicines and natural products. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

PubMed

Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

2015-01-01

We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

The History of Infant Formula: Quality, Safety, and Standard Methods.

PubMed

Wargo, Wayne F

2016-01-01

Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.

A practical method to standardise and optimise the Philips DoseRight 2.0 CT automatic exposure control system.

PubMed

Wood, T J; Moore, C S; Stephens, A; Saunderson, J R; Beavis, A W

2015-09-01

Given the increasing use of computed tomography (CT) in the UK over the last 30 years, it is essential to ensure that all imaging protocols are optimised to keep radiation doses as low as reasonably practicable, consistent with the intended clinical task. However, the complexity of modern CT equipment can make this task difficult to achieve in practice. Recent results of local patient dose audits have shown discrepancies between two Philips CT scanners that use the DoseRight 2.0 automatic exposure control (AEC) system in the 'automatic' mode of operation. The use of this system can result in drifting dose and image quality performance over time as it is designed to evolve based on operator technique. The purpose of this study was to develop a practical technique for configuring examination protocols on four CT scanners that use the DoseRight 2.0 AEC system in the 'manual' mode of operation. This method used a uniform phantom to generate reference images which form the basis for how the AEC system calculates exposure factors for any given patient. The results of this study have demonstrated excellent agreement in the configuration of the CT scanners in terms of average patient dose and image quality when using this technique. This work highlights the importance of CT protocol harmonisation in a modern Radiology department to ensure both consistent image quality and radiation dose. Following this study, the average radiation dose for a range of CT examinations has been reduced without any negative impact on clinical image quality.

[Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads].

PubMed

Orta Mira, Nieves; Serrano, María del Remedio Guna; Martínez, José-Carlos Latorre; Ovies, María Rosario; Poveda, Marta; de Gopegui, Enrique Ruiz; Cardona, Concepción Gimeno

2011-12-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarized the results obtained in the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads and HCV genotyping. In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 3-5 log(10) copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (22.6% on average) obtained values out of the accepted range (mean ± 0.2 log(10)copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (Δ<0.5 log(10)copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 86.1% in the case of HCV and 87.1% in HBV, obtained all the results within the accepted range (mean ± 1.96 SD log(10)UI/mL). Post-analytical errors due to mistranscription of the results were detected in these controls. Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable. Copyright © 2011 Elsevier España S.L. All rights reserved.

Roadmap for High School Feedback Reports: Key Focus Areas to Ensure Quality Implementation. Data for Action

ERIC Educational Resources Information Center

Data Quality Campaign, 2014

2014-01-01

High school feedback reports let school and district leaders know where their students go after graduation and how well they are prepared for college and beyond. This roadmap discusses the seven key focus areas the Data Quality Campaign (DQC) recommends states work on to ensure quality implementation of high school feedback reports.

Statistical process management: An essential element of quality improvement

NASA Astrophysics Data System (ADS)

Buckner, M. R.

Successful quality improvement requires a balanced program involving the three elements that control quality: organization, people and technology. The focus of the SPC/SPM User's Group is to advance the technology component of Total Quality by networking within the Group and by providing an outreach within Westinghouse to foster the appropriate use of statistic techniques to achieve Total Quality. SPM encompasses the disciplines by which a process is measured against its intrinsic design capability, in the face of measurement noise and other obscuring variability. SPM tools facilitate decisions about the process that generated the data. SPM deals typically with manufacturing processes, but with some flexibility of definition and technique it accommodates many administrative processes as well. The techniques of SPM are those of Statistical Process Control, Statistical Quality Control, Measurement Control, and Experimental Design. In addition, techniques such as job and task analysis, and concurrent engineering are important elements of systematic planning and analysis that are needed early in the design process to ensure success. The SPC/SPM User's Group is endeavoring to achieve its objectives by sharing successes that have occurred within the member's own Westinghouse department as well as within other US and foreign industry. In addition, failures are reviewed to establish lessons learned in order to improve future applications. In broader terms, the Group is interested in making SPM the accepted way of doing business within Westinghouse.

Automated Quality Control of in Situ Soil Moisture from the North American Soil Moisture Database Using NLDAS-2 Products

NASA Astrophysics Data System (ADS)

Ek, M. B.; Xia, Y.; Ford, T.; Wu, Y.; Quiring, S. M.

2015-12-01

The North American Soil Moisture Database (NASMD) was initiated in 2011 to provide support for developing climate forecasting tools, calibrating land surface models and validating satellite-derived soil moisture algorithms. The NASMD has collected data from over 30 soil moisture observation networks providing millions of in situ soil moisture observations in all 50 states as well as Canada and Mexico. It is recognized that the quality of measured soil moisture in NASMD is highly variable due to the diversity of climatological conditions, land cover, soil texture, and topographies of the stations and differences in measurement devices (e.g., sensors) and installation. It is also recognized that error, inaccuracy and imprecision in the data set can have significant impacts on practical operations and scientific studies. Therefore, developing an appropriate quality control procedure is essential to ensure the data is of the best quality. In this study, an automated quality control approach is developed using the North American Land Data Assimilation System phase 2 (NLDAS-2) Noah soil porosity, soil temperature, and fraction of liquid and total soil moisture to flag erroneous and/or spurious measurements. Overall results show that this approach is able to flag unreasonable values when the soil is partially frozen. A validation example using NLDAS-2 multiple model soil moisture products at the 20 cm soil layer showed that the quality control procedure had a significant positive impact in Alabama, North Carolina, and West Texas. It had a greater impact in colder regions, particularly during spring and autumn. Over 433 NASMD stations have been quality controlled using the methodology proposed in this study, and the algorithm will be implemented to control data quality from the other ~1,200 NASMD stations in the near future.

USGS Laboratory Review Program Ensures Analytical Quality

USGS Publications Warehouse

Erdmann, David E.

1995-01-01

The USGS operates a review program for laboratories that analyze samples for USGS environmental investigations. This program has been effective in providing QA feedback to laboratories while ensuring that analytical data are consistent, of satisfactory quality, and meet the data objectives of the investigation.

Role for ribosome-associated complex and stress-seventy subfamily B (RAC-Ssb) in integral membrane protein translation.

PubMed

Acosta-Sampson, Ligia; Döring, Kristina; Lin, Yuping; Yu, Vivian Y; Bukau, Bernd; Kramer, Günter; Cate, Jamie H D

2017-12-01

Targeting of most integral membrane proteins to the endoplasmic reticulum is controlled by the signal recognition particle, which recognizes a hydrophobic signal sequence near the protein N terminus. Proper folding of these proteins is monitored by the unfolded protein response and involves protein degradation pathways to ensure quality control. Here, we identify a new pathway for quality control of major facilitator superfamily transporters that occurs before the first transmembrane helix, the signal sequence recognized by the signal recognition particle, is made by the ribosome. Increased rates of translation elongation of the N-terminal sequence of these integral membrane proteins can divert the nascent protein chains to the ribosome-associated complex and stress-seventy subfamily B chaperones. We also show that quality control of integral membrane proteins by ribosome-associated complex-stress-seventy subfamily B couples translation rate to the unfolded protein response, which has implications for understanding mechanisms underlying human disease and protein production in biotechnology. © 2017 by The American Society for Biochemistry and Molecular Biology, Inc.

An Energy Saving Green Plug Device for Nonlinear Loads

NASA Astrophysics Data System (ADS)

Bloul, Albe; Sharaf, Adel; El-Hawary, Mohamed

2018-03-01

The paper presents a low cost a FACTS Based flexible fuzzy logic based modulated/switched tuned arm filter and Green Plug compensation (SFC-GP) scheme for single-phase nonlinear loads ensuring both voltage stabilization and efficient energy utilization. The new Green Plug-Switched filter compensator SFC modulated LC-Filter PWM Switched Capacitive Compensation Devices is controlled using a fuzzy logic regulator to enhance power quality, improve power factor at the source and reduce switching transients and inrush current conditions as well harmonic contents in source current. The FACTS based SFC-GP Device is a member of family of Green Plug/Filters/Compensation Schemes used for efficient energy utilization, power quality enhancement and voltage/inrush current/soft starting control using a dynamic error driven fuzzy logic controller (FLC). The device with fuzzy logic controller is validated using the Matlab / Simulink Software Environment for enhanced power quality (PQ), improved power factor and reduced inrush currents. This is achieved using modulated PWM Switching of the Filter-Capacitive compensation scheme to cope with dynamic type nonlinear and inrush cyclical loads..

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Effect of production variables on microbiological removal in locally-produced ceramic filters for household water treatment.

PubMed

Lantagne, Daniele; Klarman, Molly; Mayer, Ally; Preston, Kelsey; Napotnik, Julie; Jellison, Kristen

2010-06-01

Diarrhoeal diseases cause an estimated 1.87 million child deaths per year. Point-of-use filtration using locally made ceramic filters improves microbiological quality of stored drinking water and prevents diarrhoeal disease. Scaling-up ceramic filtration is inhibited by lack of universal quality control standards. We investigated filter production variables to determine their affect on microbiological removal during 5-6 weeks of simulated normal use. Decreases in the clay:sawdust ratio and changes in the burnable decreased effectiveness of the filter. Method of silver application and shape of filter did not impact filter effectiveness. A maximum flow rate of 1.7 l(-hr) was established as a potential quality control measure for one particular filter to ensure 99% (2- log(10)) removal of total coliforms. Further research is indicated to determine additional production variables associated with filter effectiveness and develop standardized filter production procedures prior to scaling-up.

Screening for the anti-inflammation quality markers of Xiaojin Pills based on HPLC-MS/MS method, COX-2 inhibition test and protein interaction network.

PubMed

Xiong, Xi; He, Ya-Nan; Feng, Bi; Pan, Yuan; Zhang, Hai-Zhu; Ke, Xiu-Mei; Zhang, Yi; Yang, Ming; Han, Li; Zhang, Ding-Kun

2018-05-10

Nowadays, breast disorders seriously affect women's health in an increasing number. In China, Xiaojin Pills are commonly used in the treatment of breast diseases. Doctors have concluded that the combined use of Xiaojin Pills with conventional therapy can significantly improve the efficacy with fewer side effects. However, the prescription of Xiaojin Pills is complicated and their quality control methods cannot completely ensure the quality of Xiaojin Pills. On the basis of its mechanism, our study combined chemical evaluation and biological evaluation to identify the anti-inflammatory markers of Xiaojin Pills. In this manuscript, 13 compounds in Xiaojin Pills were quantified. At the same time, the cyclooxygenase-2 inhibition rates of different Xiaojin Pills were measured and the possible markers were screened by spectrum-effect relationship. Further, anti-inflammatory activities of markers were verified and protein interaction network was analyzed, identifying the components of Protocatechuate, Beta-Boswellic acid and Levistilide A as the anti-inflammatory quality markers of Xiaojin Pills. We hope our studies can provide a scientific theoretical basis for accurately quality control of Xiaojin Pills and reasonable suggestions for pharmaceutical companies and new ideas for the quality control of other medicines.

Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project.

PubMed

Bonertz, A; Roberts, G; Slater, J E; Bridgewater, J; Rabin, R L; Hoefnagel, M; Timon, M; Pini, C; Pfaar, O; Sheikh, A; Ryan, D; Akdis, C; Goldstein, J; Poulsen, L K; van Ree, R; Rhyner, C; Barber, D; Palomares, O; Pawankar, R; Hamerlijnk, D; Klimek, L; Agache, I; Angier, E; Casale, T; Fernandez-Rivas, M; Halken, S; Jutel, M; Lau, S; Pajno, G; Sturm, G; Varga, E M; Gerth van Wijk, R; Bonini, S; Muraro, A; Vieths, S

2018-04-01

Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. As the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Atmosphere and water quality monitoring on Space Station Freedom

NASA Technical Reports Server (NTRS)

Niu, William

1990-01-01

In Space Station Freedom air and water will be supplied in closed loop systems. The monitoring of air and water qualities will ensure the crew health for the long mission duration. The Atmosphere Composition Monitor consists of the following major instruments: (1) a single focusing mass spectrometer to monitor major air constituents and control the oxygen/nitrogen addition for the Space Station; (2) a gas chromatograph/mass spectrometer to detect trace contaminants; (3) a non-dispersive infrared spectrometer to determine carbon monoxide concentration; and (4) a laser particle counter for measuring particulates in the air. An overview of the design and development concepts for the air and water quality monitors is presented.

Approaches to ensuring and improving quality in the context of health system strengthening: a cross-site analysis of the five African Health Initiative Partnership programs

PubMed Central

2013-01-01

Background Integrated into the work in health systems strengthening (HSS) is a growing focus on the importance of ensuring quality of the services delivered and systems which support them. Understanding how to define and measure quality in the different key World Health Organization building blocks is critical to providing the information needed to address gaps and identify models for replication. Description of approaches We describe the approaches to defining and improving quality across the five country programs funded through the Doris Duke Charitable Foundation African Health Initiative. While each program has independently developed and implemented country-specific approaches to strengthening health systems, they all included quality of services and systems as a core principle. We describe the differences and similarities across the programs in defining and improving quality as an embedded process essential for HSS to achieve the goal of improved population health. The programs measured quality across most or all of the six WHO building blocks, with specific areas of overlap in improving quality falling into four main categories: 1) defining and measuring quality; 2) ensuring data quality, and building capacity for data use for decision making and response to quality measurements; 3) strengthened supportive supervision and/or mentoring; and 4) operational research to understand the factors associated with observed variation in quality. Conclusions Learning the value and challenges of these approaches to measuring and improving quality across the key components of HSS as the projects continue their work will help inform similar efforts both now and in the future to ensure quality across the critical components of a health system and the impact on population health. PMID:23819662

NREL, Toyota Partnering on Plug-In Hybrid Electric Vehicle Grid Integration

Science.gov Websites

find out how all those new vehicles charging up at the same time will affect power quality on the distribution grid. Knowing how much is too much for the grid will lead to better strategies to monitor and control distribution, ensuring that as more PHEV owners plug in, the grid is ready. To learn more about

The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

NASA Astrophysics Data System (ADS)

Zhan, Jinliang; Lu, Pei

2006-11-01

Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

Quality Aware Compression of Electrocardiogram Using Principal Component Analysis.

PubMed

Gupta, Rajarshi

2016-05-01

Electrocardiogram (ECG) compression finds wide application in various patient monitoring purposes. Quality control in ECG compression ensures reconstruction quality and its clinical acceptance for diagnostic decision making. In this paper, a quality aware compression method of single lead ECG is described using principal component analysis (PCA). After pre-processing, beat extraction and PCA decomposition, two independent quality criteria, namely, bit rate control (BRC) or error control (EC) criteria were set to select optimal principal components, eigenvectors and their quantization level to achieve desired bit rate or error measure. The selected principal components and eigenvectors were finally compressed using a modified delta and Huffman encoder. The algorithms were validated with 32 sets of MIT Arrhythmia data and 60 normal and 30 sets of diagnostic ECG data from PTB Diagnostic ECG data ptbdb, all at 1 kHz sampling. For BRC with a CR threshold of 40, an average Compression Ratio (CR), percentage root mean squared difference normalized (PRDN) and maximum absolute error (MAE) of 50.74, 16.22 and 0.243 mV respectively were obtained. For EC with an upper limit of 5 % PRDN and 0.1 mV MAE, the average CR, PRDN and MAE of 9.48, 4.13 and 0.049 mV respectively were obtained. For mitdb data 117, the reconstruction quality could be preserved up to CR of 68.96 by extending the BRC threshold. The proposed method yields better results than recently published works on quality controlled ECG compression.

Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs.

PubMed

Abraham, Sushil; Bain, David; Bowers, John; Larivee, Victor; Leira, Francisco; Xie, Jasmina

2015-01-01

The technology transfer of biological products is a complex process requiring control of multiple unit operations and parameters to ensure product quality and process performance. To achieve product commercialization, the technology transfer sending unit must successfully transfer knowledge about both the product and the process to the receiving unit. A key strategy for maximizing successful scale-up and transfer efforts is the effective use of engineering and shake-down runs to confirm operational performance and product quality prior to embarking on good manufacturing practice runs such as process performance qualification runs. We consider key factors to consider in making the decision to perform shake-down or engineering runs. We also present industry benchmarking results of how engineering runs are used in drug substance technology transfers alongside the main themes and best practices that have emerged. Our goal is to provide companies with a framework for ensuring the "right first time" technology transfers with effective deployment of resources within increasingly aggressive timeline constraints. © PDA, Inc. 2015.

The evolution of peer review as a basis for scientific publication: directional selection towards a robust discipline?

PubMed

Ferreira, Catarina; Bastille-Rousseau, Guillaume; Bennett, Amanda M; Ellington, E Hance; Terwissen, Christine; Austin, Cayla; Borlestean, Adrian; Boudreau, Melanie R; Chan, Kevin; Forsythe, Adrian; Hossie, Thomas J; Landolt, Kristen; Longhi, Jessica; Otis, Josée-Anne; Peers, Michael J L; Rae, Jason; Seguin, Jacob; Watt, Cristen; Wehtje, Morgan; Murray, Dennis L

2016-08-01

Peer review is pivotal to science and academia, as it represents a widely accepted strategy for ensuring quality control in scientific research. Yet, the peer-review system is poorly adapted to recent changes in the discipline and current societal needs. We provide historical context for the cultural lag that governs peer review that has eventually led to the system's current structural weaknesses (voluntary review, unstandardized review criteria, decentralized process). We argue that some current attempts to upgrade or otherwise modify the peer-review system are merely sticking-plaster solutions to these fundamental flaws, and therefore are unlikely to resolve them in the long term. We claim that for peer review to be relevant, effective, and contemporary with today's publishing demands across scientific disciplines, its main components need to be redesigned. We propose directional changes that are likely to improve the quality, rigour, and timeliness of peer review, and thereby ensure that this critical process serves the community it was created for. © 2015 Cambridge Philosophical Society.

Mindcontrol: A web application for brain segmentation quality control.

PubMed

Keshavan, Anisha; Datta, Esha; M McDonough, Ian; Madan, Christopher R; Jordan, Kesshi; Henry, Roland G

2018-04-15

Tissue classification plays a crucial role in the investigation of normal neural development, brain-behavior relationships, and the disease mechanisms of many psychiatric and neurological illnesses. Ensuring the accuracy of tissue classification is important for quality research and, in particular, the translation of imaging biomarkers to clinical practice. Assessment with the human eye is vital to correct various errors inherent to all currently available segmentation algorithms. Manual quality assurance becomes methodologically difficult at a large scale - a problem of increasing importance as the number of data sets is on the rise. To make this process more efficient, we have developed Mindcontrol, an open-source web application for the collaborative quality control of neuroimaging processing outputs. The Mindcontrol platform consists of a dashboard to organize data, descriptive visualizations to explore the data, an imaging viewer, and an in-browser annotation and editing toolbox for data curation and quality control. Mindcontrol is flexible and can be configured for the outputs of any software package in any data organization structure. Example configurations for three large, open-source datasets are presented: the 1000 Functional Connectomes Project (FCP), the Consortium for Reliability and Reproducibility (CoRR), and the Autism Brain Imaging Data Exchange (ABIDE) Collection. These demo applications link descriptive quality control metrics, regional brain volumes, and thickness scalars to a 3D imaging viewer and editing module, resulting in an easy-to-implement quality control protocol that can be scaled for any size and complexity of study. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Introduction to Food Analysis

NASA Astrophysics Data System (ADS)

Nielsen, S. Suzanne

Investigations in food science and technology, whether by the food industry, governmental agencies, or universities, often require determination of food composition and characteristics. Trends and demands of consumers, the food industry, and national and international regulations challenge food scientists as they work to monitor food composition and to ensure the quality and safety of the food supply. All food products require analysis as part of a quality management program throughout the development process (including raw ingredients), through production, and after a product is in the market. In addition, analysis is done of problem samples and competitor products. The characteristics of foods (i.e., chemical composition, physical properties, sensory properties) are used to answer specific questions for regulatory purposes and typical quality control. The nature of the sample and the specific reason for the analysis commonly dictate the choice of analytical methods. Speed, precision, accuracy, and ruggedness often are key factors in this choice. Validation of the method for the specific food matrix being analyzed is necessary to ensure usefulness of the method. Making an appropriate choice of the analytical technique for a specific application requires a good knowledge of the various techniques (Fig. 1.1). For example, your choice of method to determine the salt content of potato chips would be different if it is for nutrition labeling than for quality control. The success of any analytical method relies on the proper selection and preparation of the food sample, carefully performing the analysis, and doing the appropriate calculations and interpretation of the data. Methods of analysis developed and endorsed by several nonprofit scientific organizations allow for standardized comparisons of results between different laboratories and for evaluation of less standard procedures. Such official methods are critical in the analysis of foods, to ensure that they meet the legal requirements established by governmental agencies. Government regulations and international standards most relevant to the analysis of foods are mentioned here but covered in more detail in Chap. 2, and nutrition labeling regulations in the USA are covered in Chap. 3. Internet addresses for many of the organizations and government agencies discussed are given at the end of this chapter.

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2012 CFR

2012-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2013 CFR

2013-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

INDUSTRIE 4.0 - Automation in weft knitting technology

NASA Astrophysics Data System (ADS)

Simonis, K.; Gloy, Y.-S.; Gries, T.

2016-07-01

Industry 4.0 applies to the knitting industry. Regarding the knitting process retrofitting activities are executed mostly manually by an operator on the basis on the operator's experience. In doing so, the knitted fabric is not necessarily produced in the most efficient way regarding process speed and fabric quality aspects. The knitting division at ITA is concentrating on project activities regarding automation and Industry 4.0. ITA is working on analysing the correspondences of the knitting process parameters and their influence on the fabric quality. By using e.g. the augmented reality technology, the operator will be supported when setting up the knitting machine in case of product or pattern change - or in case of an intervention when production errors occur. Furthermore, the RFID-Technology offers great possibilities to ensure information flow between sub-processes of the fragmented textile process chain. ITA is using RFID-chips to save yarn production information and connect the information to the fabric producing machine control. In addition, ITA is currently working on integrating image processing systems into the large circular knitting machine in order to ensure online-quality measurement of the knitted fabrics. This will lead to a self-optimizing and selflearning knitting machine.

Ensuring Data Quality in Extension Research and Evaluation Studies

ERIC Educational Resources Information Center

Radhakrishna, Rama; Tobin, Daniel; Brennan, Mark; Thomson, Joan

2012-01-01

This article presents a checklist as a guide for Extension professionals to use in research and evaluation studies they carry out. A total of 40 statements grouped under eight data quality components--relevance, objectivity, validity, reliability, integrity, generalizability, completeness, and utility--are identified to ensure that research…

76 FR 68373 - Proposed Revision to Vintage Date Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-04

... foreign, while still ensuring that consumers are provided with adequate information as to the identity and... labels provide the consumer with adequate information as to the identity and quality of the product. The... mandate to ensure that consumers have adequate information about the quality and identity of the product...

High Performance Building Mockup in FLEXLAB

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

McNeil, Andrew; Kohler, Christian; Lee, Eleanor S.

Genentech has ambitious energy and indoor environmental quality performance goals for Building 35 (B35) being constructed by Webcor at the South San Francisco campus. Genentech and Webcor contracted with the Lawrence Berkeley National Laboratory (LBNL) to test building systems including lighting, lighting controls, shade fabric, and automated shading controls in LBNL’s new FLEXLAB facility. The goal of the testing is to ensure that the systems installed in the new office building will function in a way that reduces energy consumption and provides a comfortable work environment for employees.

Use of a control chart to monitor diarrhoea admissions: a quality improvement exercise in West Kalimantan Provincial Hospital, Pontianak, Indonesia.

PubMed

Purba, M

1999-09-01

Data on the number of admissions for diarrhoea each week to the West Kalimantan Provincial Hospital, Pontianak, Indonesia over a 5 year period, 1992-1996, were collected. After cleaning and exclusion of extreme values, transformation was then performed to ensure that the data were free of special cause variation and normally distributed. A control chart was then constructed to provide an 'early warning' system for hospital authorities in order to facilitate the management of the epidemic and to improve patient care.

Control of infection in an international airline.

PubMed

Kelly, M

1993-05-01

The paper examines the possible sources of infection on an international aircraft, including the provision of food, the supply of drinking water, and the removal of waste. It considers aspects of control, and explains some of the steps which have to be taken by a major international carrier to ensure that the high quality expected by the customer is provided in all areas of the world, even those where natural resources and expertise may be limited. The emphasis is on providing a safe product, and removing any possible risk of infection of the passengers.

Real-time feedback control of twin-screw wet granulation based on image analysis.

PubMed

Madarász, Lajos; Nagy, Zsombor Kristóf; Hoffer, István; Szabó, Barnabás; Csontos, István; Pataki, Hajnalka; Démuth, Balázs; Szabó, Bence; Csorba, Kristóf; Marosi, György

2018-06-04

The present paper reports the first dynamic image analysis-based feedback control of continuous twin-screw wet granulation process. Granulation of the blend of lactose and starch was selected as a model process. The size and size distribution of the obtained particles were successfully monitored by a process camera coupled with an image analysis software developed by the authors. The validation of the developed system showed that the particle size analysis tool can determine the size of the granules with an error of less than 5 µm. The next step was to implement real-time feedback control of the process by controlling the liquid feeding rate of the pump through a PC, based on the real-time determined particle size results. After the establishment of the feedback control, the system could correct different real-life disturbances, creating a Process Analytically Controlled Technology (PACT), which guarantees the real-time monitoring and controlling of the quality of the granules. In the event of changes or bad tendencies in the particle size, the system can automatically compensate the effect of disturbances, ensuring proper product quality. This kind of quality assurance approach is especially important in the case of continuous pharmaceutical technologies. Copyright © 2018 Elsevier B.V. All rights reserved.

Integration of Aquifer Storage Transfer and Recovery and HACCP for Ensuring Drinking Water Quality

NASA Astrophysics Data System (ADS)

Lee, S. I.; Ji, H. W.

2015-12-01

The integration of ASTR (Aquifer Storage Transfer and Recovery) and HACCP (Hazard Analysis and Critical Control Point) is being attempted to ensure drinking water quality in a delta area. ASTR is a water supply system in which surface water is injected into a well for storage and recovered from a different well. During the process natural water treatment is achieved in the aquifer. ASTR has advantages over surface reservoirs in that the water is protected from external contaminants and free from water loss by evaporation. HACCP, originated from the food industry, can efficiently manage hazards and reduce risks when it is introduced to the drinking water production. The study area is the located in the Nakdong River Delta, South Korea. Water quality of this region has been deteriorated due to the increased pollution loads from the upstream cities and industrial complexes. ASTR equipped with HACCP system is suggested as a means to heighten the public trust in drinking water. After the drinking water supply system using ASTR was decomposed into ten processes, principles of HACCP were applied. Hazardous event analysis was conducted for 114 hazardous events and nine major hazardous events were identified based on the likelihood and the severity assessment. Potential risk of chemical hazards, as a function of amounts, travel distance and toxicity, was evaluated and the result shows the relative threat a city poses to the drinking water supply facility. Next, critical control points were determined using decision tree analysis. Critical limits, maximum and/or minimum values to which biological, chemical or physical parameters must be controlled, were established. Other procedures such as monitoring, corrective actions and will be presented.

Review of water disinfection techniques

NASA Technical Reports Server (NTRS)

Colombo, Gerald V.; Sauer, Richard L.

1987-01-01

Throughout the history of manned space flight the supply of potable water to the astronauts has presented unique problems. Of particular concern has been the microbiological quality of the potable water. This has required the development of both preflight water system servicing procedures to disinfect the systems and inflight disinfectant addition and monitoring devices to ensure continuing microbiological control. The disinfectants successfully used to date have been aqueous chlorine or iodine. Because of special system limitations the use of iodine has been the most successful for inflight use and promises to be the agent most likely to be used in the future. Future spacecraft potable, hygiene, and experiment water systems will utilize recycled water. This will present special problems for water quality control. NASA is currently conducting research and development to solve these problems.

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

NASA Astrophysics Data System (ADS)

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

2018-05-01

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

Systems and processes that ensure high quality care.

PubMed

Bassett, Sally; Westmore, Kathryn

2012-10-01

This is the second in a series of articles examining the components of good corporate governance. It considers how the structures and processes for quality governance can affect an organisation's ability to be assured about the quality of care. Complex information systems and procedures can lead to poor quality care, but sound structures and processes alone are insufficient to ensure good governance, and behavioural factors play a significant part in making sure that staff are enabled to provide good quality care. The next article in this series looks at how the information reporting of an organisation can affect its governance.

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

NASA Astrophysics Data System (ADS)

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

2018-04-01

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

Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process.

PubMed

Singh, Ravendra; Román-Ospino, Andrés D; Romañach, Rodolfo J; Ierapetritou, Marianthi; Ramachandran, Rohit

2015-11-10

The pharmaceutical industry is strictly regulated, where precise and accurate control of the end product quality is necessary to ensure the effectiveness of the drug products. For such control, the process and raw materials variability ideally need to be fed-forward in real time into an automatic control system so that a proactive action can be taken before it can affect the end product quality. Variations in raw material properties (e.g., particle size), feeder hopper level, amount of lubrication, milling and blending action, applied shear in different processing stages can affect the blend density significantly and thereby tablet weight, hardness and dissolution. Therefore, real time monitoring of powder bulk density variability and its incorporation into the automatic control system so that its effect can be mitigated proactively and efficiently is highly desired. However, real time monitoring of powder bulk density is still a challenging task because of different level of complexities. In this work, powder bulk density which has a significant effect on the critical quality attributes (CQA's) has been monitored in real time in a pilot-plant facility, using a NIR sensor. The sensitivity of the powder bulk density on critical process parameters (CPP's) and CQA's has been analyzed and thereby feed-forward controller has been designed. The measured signal can be used for feed-forward control so that the corrective actions on the density variations can be taken before they can influence the product quality. The coupled feed-forward/feed-back control system demonstrates improved control performance and improvements in the final product quality in the presence of process and raw material variations. Copyright © 2015 Elsevier B.V. All rights reserved.

Optimal shifting control strategy in inertia phase of an automatic transmission for automotive applications

NASA Astrophysics Data System (ADS)

Meng, Fei; Tao, Gang; Zhang, Tao; Hu, Yihuai; Geng, Peng

2015-08-01

Shifting quality is a crucial factor in all parts of the automobile industry. To ensure an optimal gear shifting strategy with best fuel economy for a stepped automatic transmission, the controller should be designed to meet the challenge of lacking of a feedback sensor to measure the relevant variables. This paper focuses on a new kind of automatic transmission using proportional solenoid valve to control the clutch pressure, a speed difference of the clutch based control strategy is designed for the shift control during the inertia phase. First, the mechanical system is shown and the system dynamic model is built. Second, the control strategy is designed based on the characterization analysis of models which are derived from dynamics of the drive line and electro-hydraulic actuator. Then, the controller uses conventional Proportional-Integral-Derivative control theory, and a robust two-degree-of-freedom controller is also carried out to determine the optimal control parameters to further improve the system performance. Finally, the designed control strategy with different controller is implemented on a simulation model. The compared results show that the speed difference of clutch can track the desired trajectory well and improve the shift quality effectively.

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.

Ensuring and Maintaining Quality in Schools through Central Regulation: Some Lessons from England and Wales (An Ecology of Quality in School Education)

ERIC Educational Resources Information Center

Lee, John

2002-01-01

The problem of ensuring quality in mass education systems is as old as the systems themselves. Responses to this problem reflect the political and cultural organisation of different nation states. In the USA the problem has to be dealt with at a local level. The federal government is very restricted in powers in the field of education and social…

21 CFR 212.20 - What activities must I perform to ensure drug quality?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What activities must I perform to ensure drug quality? 212.20 Section 212.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY...

21 CFR 212.20 - What activities must I perform to ensure drug quality?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What activities must I perform to ensure drug quality? 212.20 Section 212.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY...

Resources for Ensuring Quality School-to-Work Opportunities for Young Women. Draft.

ERIC Educational Resources Information Center

Wider Opportunities for Women, Inc., Washington, DC.

This annotated bibliography lists 49 resources for ensuring high quality school-to-work opportunities for young women. These resources are grouped into 10 categories: print material for middle and high school girls; videos for middle and high school girls; administrator/school guides; curriculum guides/resources for teachers; resources for…

36 CFR 1260.38 - How does the NDC ensure the quality of declassification reviews?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 36 Parks, Forests, and Public Property 3 2012-07-01 2012-07-01 false How does the NDC ensure the quality of declassification reviews? 1260.38 Section 1260.38 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION DECLASSIFICATION DECLASSIFICATION OF NATIONAL SECURITY INFORMATION The...

36 CFR 1260.38 - How does the NDC ensure the quality of declassification reviews?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false How does the NDC ensure the quality of declassification reviews? 1260.38 Section 1260.38 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION DECLASSIFICATION DECLASSIFICATION OF NATIONAL SECURITY INFORMATION The...

Making the Grade: How Boards Can Ensure Academic Quality. Second Edition

ERIC Educational Resources Information Center

Ewell, Peter

2012-01-01

"Making the Grade: How Boards Can Ensure Academic Quality"--popularly referred to as "The Little Yellow Book" by boards, faculty, provosts, and assessment specialists--provides clear guidance for the board's role in the most important "business" of academe: educating students. As public calls for greater accountability skyrocket, this new edition…

Responsibilities of regulatory agencies in the marketing of antimicrobials.

PubMed

Grein, K

2012-04-01

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

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: tuning of process controllers to meet specified performance objectives and tuning of process inputs to meet specified quality objectives. Five case studies are presented.

Food fortification: issues on quality assurance and impact evaluation in developing countries.

PubMed

Florentino, R

2003-01-01

Quality assurance and impact evaluation are essential components of a food fortification program and should be integrated in the fortification process. Quality assurance will ensure that the micronutrient meant to be delivered is indeed reaching the target population at the correct level. Impact evaluation will determine the effectiveness of food fortification as a strategy in controlling micronutrient deficiency and enable program planners to make decisions on the future of the program. In developing countries, both quality assurance and impact evaluation are often constrained not only by inadequacy of facilities as well as financial and manpower resources, but by unclear definition of objectives and inappropriate design. It is therefore necessary to consider the target audience for the quality assurance monitoring and impact evaluation in order to clearly define their objectives and in turn suit the design to these objectives, at the same time as the limitations in financial and manpower resources are considered.

Bacteriological water quality in the Lake Pontchartrain basin Louisiana following Hurricanes Katrina and Rita, September 2005

USGS Publications Warehouse

Stoeckel, Donald M.; Bushon, Rebecca N.; Demcheck, Dennis K.; Skrobialowski, Stanley C.; Kephart, Christopher M.; Bertke, Erin E.; Mailot, Brian E.; Mize, Scott V.; Fendick, Robert B.

2005-01-01

The U.S. Geological Survey (USGS), in collaboration with the Louisiana Department of Environmental Quality, monitored bacteriological quality of water at 22 sites in and around Lake Pontchartrain, La., for three consecutive weeks beginning September 13, 2005, following hurricanes Katrina and Rita and the associated flooding. Samples were collected and analyzed by USGS personnel from the USGS Louisiana Water Science Center and the USGS Ohio Water Microbiology Laboratory. Fecal-indicator bacteria (Escherichia coli, enterococci, and fecal coliform) concentrations ranged from the detection limit to 36,000 colony-forming units per 100 milliliters. Data are presented in tabular form and as plots of data in the context of available historical data and water-quality standards and criteria for each site sampled. Quality-control data were reviewed to ensure that methods performed as expected in a mobile laboratory setting.

Quality improvement in the use of medications through a drug use evaluation service.

PubMed

Stevenson, J G; Bakst, C M; Zaran, F K; Rybak, M J; Smolarek, R T; Alexander, M R

1992-10-01

Continuous quality improvement methods have the potential to improve processes that cross several disciplines. The medication system is one in which coordination of activities between physicians, pharmacists, and nurses is essential for optimal therapy to occur. DUE services can play an important role in helping to ensure that patients receive high-quality pharmaceutical care. It is necessary for pharmacy managers to review the structure, goals, and outcomes of their DUE programs to ensure that they are consistent with a philosophy of continuous improvement in the quality of drug therapy.

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

Experimental Optimization of Exposure Index and Quality of Service in Wlan Networks.

PubMed

Plets, David; Vermeeren, Günter; Poorter, Eli De; Moerman, Ingrid; Goudos, Sotirios K; Luc, Martens; Wout, Joseph

2017-07-01

This paper presents the first real-life optimization of the Exposure Index (EI). A genetic optimization algorithm is developed and applied to three real-life Wireless Local Area Network scenarios in an experimental testbed. The optimization accounts for downlink, uplink and uplink of other users, for realistic duty cycles, and ensures a sufficient Quality of Service to all users. EI reductions up to 97.5% compared to a reference configuration can be achieved in a downlink-only scenario, in combination with an improved Quality of Service. Due to the dominance of uplink exposure and the lack of WiFi power control, no optimizations are possible in scenarios that also consider uplink traffic. However, future deployments that do implement WiFi power control can be successfully optimized, with EI reductions up to 86% compared to a reference configuration and an EI that is 278 times lower than optimized configurations under the absence of power control. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Data Management and Data Quality in PERCH, a Large International Case-Control Study of Severe Childhood Pneumonia.

PubMed

Watson, Nora L; Prosperi, Christine; Driscoll, Amanda J; Higdon, Melissa M; Park, Daniel E; Sanza, Megan; DeLuca, Andrea N; Awori, Juliet O; Goswami, Doli; Hammond, Emily; Hossain, Lokman; Johnson, Catherine; Kamau, Alice; Kuwanda, Locadiah; Moore, David P; Neyzari, Omid; Onwuchekwa, Uma; Parker, David; Sapchookul, Patranuch; Seidenberg, Phil; Shamsul, Arifin; Siazeele, Kazungu; Srisaengchai, Prasong; Sylla, Mamadou; Levine, Orin S; Murdoch, David R; O'Brien, Katherine L; Wolff, Mark; Deloria Knoll, Maria

2017-06-15

The Pneumonia Etiology Research for Child Health (PERCH) study is the largest multicountry etiology study of pediatric pneumonia undertaken in the past 3 decades. The study enrolled 4232 hospitalized cases and 5325 controls over 2 years across 9 research sites in 7 countries in Africa and Asia. The volume and complexity of data collection in PERCH presented considerable logistical and technical challenges. The project chose an internet-based data entry system to allow real-time access to the data, enabling the project to monitor and clean incoming data and perform preliminary analyses throughout the study. To ensure high-quality data, the project developed comprehensive quality indicator, data query, and monitoring reports. Among the approximately 9000 cases and controls, analyzable laboratory results were available for ≥96% of core specimens collected. Selected approaches to data management in PERCH may be extended to the planning and organization of international studies of similar scope and complexity. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Improving Quality of Seal Leak Test Product using Six Sigma

NASA Astrophysics Data System (ADS)

Luthfi Malik, Abdullah; Akbar, Muhammad; Irianto, Dradjad

2016-02-01

Seal leak test part is a polyurethane material-based product. Based on past data, defect level of this product was 8%, higher than the target of 5%. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control. In the design phase, a Delphi method was used to identify factors that were critical to quality. In the measure phase, stability and process capability was measured. Fault tree analysis (FTA) and failure mode and effect analysis (FMEA) were used in the next phase to analize the root cause and to determine the priority issues. Improve phase was done by compiling, selecting, and designing alternative repair. Some improvement efforts were identified, i.e. (i) making a checklist for maintenance schedules, (ii) making written reminder form, (iii) modifying the SOP more detail, and (iv) performing a major service to the vacuum machine. To ensure the continuity of improvement efforts, some control activities were executed, i.e. (i) controlling, monitoring, documenting, and setting target frequently, (ii) implementing reward and punishment system, (iii) adding cleaning tool, and (iv) building six sigma organizational structure.

A Comprehensive Quality Evaluation System for Complex Herbal Medicine Using PacBio Sequencing, PCR-Denaturing Gradient Gel Electrophoresis, and Several Chemical Approaches

PubMed Central

Zheng, Xiasheng; Zhang, Peng; Liao, Baosheng; Li, Jing; Liu, Xingyun; Shi, Yuhua; Cheng, Jinle; Lai, Zhitian; Xu, Jiang; Chen, Shilin

2017-01-01

Herbal medicine is a major component of complementary and alternative medicine, contributing significantly to the health of many people and communities. Quality control of herbal medicine is crucial to ensure that it is safe and sound for use. Here, we investigated a comprehensive quality evaluation system for a classic herbal medicine, Danggui Buxue Formula, by applying genetic-based and analytical chemistry approaches to authenticate and evaluate the quality of its samples. For authenticity, we successfully applied two novel technologies, third-generation sequencing and PCR-DGGE (denaturing gradient gel electrophoresis), to analyze the ingredient composition of the tested samples. For quality evaluation, we used high performance liquid chromatography assays to determine the content of chemical markers to help estimate the dosage relationship between its two raw materials, plant roots of Huangqi and Danggui. A series of surveys were then conducted against several exogenous contaminations, aiming to further access the efficacy and safety of the samples. In conclusion, the quality evaluation system demonstrated here can potentially address the authenticity, quality, and safety of herbal medicines, thus providing novel insight for enhancing their overall quality control. Highlight: We established a comprehensive quality evaluation system for herbal medicine, by combining two genetic-based approaches third-generation sequencing and DGGE (denaturing gradient gel electrophoresis) with analytical chemistry approaches to achieve the authentication and quality connotation of the samples. PMID:28955365

A Comprehensive Quality Evaluation System for Complex Herbal Medicine Using PacBio Sequencing, PCR-Denaturing Gradient Gel Electrophoresis, and Several Chemical Approaches.

PubMed

Zheng, Xiasheng; Zhang, Peng; Liao, Baosheng; Li, Jing; Liu, Xingyun; Shi, Yuhua; Cheng, Jinle; Lai, Zhitian; Xu, Jiang; Chen, Shilin

2017-01-01

Herbal medicine is a major component of complementary and alternative medicine, contributing significantly to the health of many people and communities. Quality control of herbal medicine is crucial to ensure that it is safe and sound for use. Here, we investigated a comprehensive quality evaluation system for a classic herbal medicine, Danggui Buxue Formula, by applying genetic-based and analytical chemistry approaches to authenticate and evaluate the quality of its samples. For authenticity, we successfully applied two novel technologies, third-generation sequencing and PCR-DGGE (denaturing gradient gel electrophoresis), to analyze the ingredient composition of the tested samples. For quality evaluation, we used high performance liquid chromatography assays to determine the content of chemical markers to help estimate the dosage relationship between its two raw materials, plant roots of Huangqi and Danggui. A series of surveys were then conducted against several exogenous contaminations, aiming to further access the efficacy and safety of the samples. In conclusion, the quality evaluation system demonstrated here can potentially address the authenticity, quality, and safety of herbal medicines, thus providing novel insight for enhancing their overall quality control. Highlight : We established a comprehensive quality evaluation system for herbal medicine, by combining two genetic-based approaches third-generation sequencing and DGGE (denaturing gradient gel electrophoresis) with analytical chemistry approaches to achieve the authentication and quality connotation of the samples.

Elements that contribute to healthy building design.

PubMed

Loftness, Vivian; Hakkinen, Bert; Adan, Olaf; Nevalainen, Aino

2007-06-01

The elements that contribute to a healthy building are multifactorial and can be discussed from different perspectives. WE PRESENT THREE VIEWPOINTS OF DESIGNING A HEALTHY BUILDING: the importance of sustainable development, the role of occupants for ensuring indoor air quality, and ongoing developments related to indoor finishes with low chemical emissions and good fungal resistance. Sustainable design rediscovers the social, environmental, and technical values of pedestrian and mixed-use communities, using existing infrastructures including "main streets" and small-town planning principles and recapturing indoor-outdoor relationships. This type of design introduces nonpolluting materials and assemblies with lower energy requirements and higher durability and recyclability. Building occupants play a major role in maintaining healthy indoor environments, especially in residences. Contributors to indoor air quality include cleaning habits and other behaviors; consumer products, furnishings, and appliances purchases, as well as where and how the occupants use them. Certification of consumer products and building materials as low-emitting products is a primary control measure for achieving good indoor air quality. Key products in this respect are office furniture, flooring, paints and coatings, adhesives and sealants, wall coverings, wood products, textiles, insulation, and cleaning products. Finishing materials play a major role in the quality of indoor air as related to moisture retention and mold growth. Sustainable design emphasizes the needs of infrastructure, lower energy consumption, durability, and recyclability. To ensure good indoor air quality, the product development for household use should aim to reduce material susceptibility to contaminants such as mold and should adopt consumer-oriented product labeling.

A new dataset validation system for the Planetary Science Archive

NASA Astrophysics Data System (ADS)

Manaud, N.; Zender, J.; Heather, D.; Martinez, S.

2007-08-01

The Planetary Science Archive is the official archive for the Mars Express mission. It has received its first data by the end of 2004. These data are delivered by the PI teams to the PSA team as datasets, which are formatted conform to the Planetary Data System (PDS). The PI teams are responsible for analyzing and calibrating the instrument data as well as the production of reduced and calibrated data. They are also responsible of the scientific validation of these data. ESA is responsible of the long-term data archiving and distribution to the scientific community and must ensure, in this regard, that all archived products meet quality. To do so, an archive peer-review is used to control the quality of the Mars Express science data archiving process. However a full validation of its content is missing. An independent review board recently recommended that the completeness of the archive as well as the consistency of the delivered data should be validated following well-defined procedures. A new validation software tool is being developed to complete the overall data quality control system functionality. This new tool aims to improve the quality of data and services provided to the scientific community through the PSA, and shall allow to track anomalies in and to control the completeness of datasets. It shall ensure that the PSA end-users: (1) can rely on the result of their queries, (2) will get data products that are suitable for scientific analysis, (3) can find all science data acquired during a mission. We defined dataset validation as the verification and assessment process to check the dataset content against pre-defined top-level criteria, which represent the general characteristics of good quality datasets. The dataset content that is checked includes the data and all types of information that are essential in the process of deriving scientific results and those interfacing with the PSA database. The validation software tool is a multi-mission tool that has been designed to provide the user with the flexibility of defining and implementing various types of validation criteria, to iteratively and incrementally validate datasets, and to generate validation reports.

Mitochondrial quality control and communications with the nucleus are important in maintaining mitochondrial function and cell health☆☆☆

PubMed Central

Kotiadis, Vassilios N.; Duchen, Michael R.; Osellame, Laura D.

2014-01-01

Background The maintenance of cell metabolism and homeostasis is a fundamental characteristic of living organisms. In eukaryotes, mitochondria are the cornerstone of these life supporting processes, playing leading roles in a host of core cellular functions, including energy transduction, metabolic and calcium signalling, and supporting roles in a number of biosynthetic pathways. The possession of a discrete mitochondrial genome dictates that the maintenance of mitochondrial ‘fitness’ requires quality control mechanisms which involve close communication with the nucleus. Scope of review This review explores the synergistic mechanisms that control mitochondrial quality and function and ensure cellular bioenergetic homeostasis. These include antioxidant defence mechanisms that protect against oxidative damage caused by reactive oxygen species, while regulating signals transduced through such free radicals. Protein homeostasis controls import, folding, and degradation of proteins underpinned by mechanisms that regulate bioenergetic capacity through the mitochondrial unfolded protein response. Autophagic machinery is recruited for mitochondrial turnover through the process of mitophagy. Mitochondria also communicate with the nucleus to exact specific transcriptional responses through retrograde signalling pathways. Major conclusions The outcome of mitochondrial quality control is not only reliant on the efficient operation of the core homeostatic mechanisms but also in the effective interaction of mitochondria with other cellular components, namely the nucleus. General significance Understanding mitochondrial quality control and the interactions between the organelle and the nucleus will be crucial in developing therapies for the plethora of diseases in which the pathophysiology is determined by mitochondrial dysfunction. This article is part of a Special Issue entitled Frontiers of Mitochondrial Research. PMID:24211250

Effective Process Design for the Production of HIC-Resistant Linepipe Steels

NASA Astrophysics Data System (ADS)

Nieto, J.; Elías, T.; López, G.; Campos, G.; López, F.; Garcia, R.; De, Amar K.

2013-09-01

Production of slabs for sour service applications requires stringent control in slab internal quality and secondary processing so as to guarantee resistance against hydrogen-induced cracking (HIC). ArcelorMittal Steelmaking facility at Lazaro Cardenas, Mexico had recently implemented key steelmaking and casting processing technologies for production of sound, centerline free slabs for catering to the growing API Linepipe and off-shore market for sour service applications. State-of-the-art steelmaking with use of residual-free Direct-reduced Iron and continuous casting facilities with dynamic soft reduction were introduced for the production of slabs with ultra clean centerline. Introduction of controlled cooling of slabs for atomic hydrogen control well below 2 ppm has enabled production of slabs suitable for excellent HIC-resistant plate processing. Substantial tonnages of slabs were produced for production of API X52-X65 grade plates and pipes for sour service. Stringent quality control at each stage of steelmaking, casting, and slab inspection ensured slabs with excellent internal quality suitable for HIC resistance to be guaranteed in final product (Plates & Pipes). Details of production steps which resulted in successful HIC-resistant slab production have been described in this article.

Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

PubMed

Boiret, Mathieu; Chauchard, Fabien

2017-01-01

Near-infrared (NIR) spectroscopy is a non-destructive analytical technique that enables better-understanding and optimization of pharmaceutical processes and final drug products. The use in line is often limited by acquisition speed and sampling area. This work focuses on performing a multipoint measurement at high acquisition speed at the end of the manufacturing process on a conveyor belt system to control both the distribution and the content of active pharmaceutical ingredient within final drug products, i.e., tablets. A specially designed probe with several collection fibers was developed for this study. By measuring spectral and spatial information, it provides physical and chemical knowledge on the final drug product. The NIR probe was installed on a conveyor belt system that enables the analysis of a lot of tablets. The use of these NIR multipoint measurement probes on a conveyor belt system provided an innovative method that has the potential to be used as a new paradigm to ensure the drug product quality at the end of the manufacturing process and as a new analytical method for the real-time release control strategy. Graphical abstract Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

A multiple functional connector for high-resolution optical satellites

NASA Astrophysics Data System (ADS)

She, Fengke; Zheng, Gangtie

2017-11-01

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

[Validation and verfication of microbiology methods].

PubMed

Camaró-Sala, María Luisa; Martínez-García, Rosana; Olmos-Martínez, Piedad; Catalá-Cuenca, Vicente; Ocete-Mochón, María Dolores; Gimeno-Cardona, Concepción

2015-01-01

Clinical microbiologists should ensure, to the maximum level allowed by the scientific and technical development, the reliability of the results. This implies that, in addition to meeting the technical criteria to ensure their validity, they must be performed with a number of conditions that allows comparable results to be obtained, regardless of the laboratory that performs the test. In this sense, the use of recognized and accepted reference methodsis the most effective tool for these guarantees. The activities related to verification and validation of analytical methods has become very important, as there is continuous development, as well as updating techniques and increasingly complex analytical equipment, and an interest of professionals to ensure quality processes and results. The definitions of validation and verification are described, along with the different types of validation/verification, and the types of methods, and the level of validation necessary depending on the degree of standardization. The situations in which validation/verification is mandatory and/or recommended is discussed, including those particularly related to validation in Microbiology. It stresses the importance of promoting the use of reference strains as controls in Microbiology and the use of standard controls, as well as the importance of participation in External Quality Assessment programs to demonstrate technical competence. The emphasis is on how to calculate some of the parameters required for validation/verification, such as the accuracy and precision. The development of these concepts can be found in the microbiological process SEIMC number 48: «Validation and verification of microbiological methods» www.seimc.org/protocols/microbiology. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

PubMed

Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

2011-12-01

Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

[ORGANIZATION OF THE QUALITY CONTROL OF PLACEMENT AND ACCOMMODATION OF PARTICIPANTS ATTENDANTS AND GUESTS OF THE XXII OLYMPIC WINTER GAMES AND XI PARALYMPIC WINTER GAMES OF 2014 IN THE RESORT CITY OF SOCHI].

PubMed

Gorskiĭ, A A; Gus'kov, A S; Pochtareva, E S; Klindukhov, V P; Nikolaevich, P N; Grechanaia, T V; Vechemyaia, E A; Biriukov, V A; Bozhko, I I; Kulichenko, A N; Taran, T V; Zaĭtsev, A A; Tushina, O V

2015-01-01

There is presented the analysis of activities of the Federal Service for Supervision of Consumer Rights protection and Human Welfare to ensure adequate conditions of accommodation of the participants, attendants and guests of the XXII Olympic Winter Games and XI Paralympic Winter Games of 2014 in the Resort city of Sochi according to regulated requirements. There were detected ways of the strengthening the supervision for the quality of the accommodation during mass sports activities for the assurance of the rights for consumers.

Forming a Team to Ensure High-Quality Measurement in Education Studies. REL 2014-052

ERIC Educational Resources Information Center

Kisker, Ellen Eliason; Boller, Kimberly

2014-01-01

This brief provides tips for forming a team of staff and consultants with the needed expertise to make key measurement decisions that will ensure high-quality data for answering the study's research questions. The brief outlines the main responsibilities of measurement team members. It also describes typical measurement tasks and discusses…

Role and Responsibility of Board of Governors [BOG] in Ensuring Educational Quality in Colleges & Universities

ERIC Educational Resources Information Center

Naik, B. M.

2012-01-01

The paper presents in brief the need and importance of effective, imaginative and responsible governing boards in colleges and universities, so as to ensure educational quality. BOG should engage fruitfully with the principal and activities in college/ university. UGC, AICTE have now prescribed creation of effective boards for both government and…

Self-assessment procedure using fuzzy sets

NASA Astrophysics Data System (ADS)

Mimi, Fotini

2000-10-01

Self-Assessment processes, initiated by a company itself and carried out by its own people, are considered to be the starting point for a regular strategic or operative planning process to ensure a continuous quality improvement. Their importance has increased by the growing relevance and acceptance of international quality awards such as the Malcolm Baldrige National Quality Award, the European Quality Award and the Deming Prize. Especially award winners use the instrument of a systematic and regular Self-Assessment and not only because they have to verify their quality and business results for at least three years. The Total Quality Model of the European Foundation for Quality Management (EFQM), used for the European Quality Award, is the basis for Self-Assessment in Europe. This paper presents a self-assessment supporting method based on a methodology of fuzzy control systems providing an effective means of converting the linguistic approximation into an automatic control strategy. In particular, the elements of the Quality Model mentioned above are interpreted as linguistic variables. The LR-type of a fuzzy interval is used for their representation. The input data has a qualitative character based on empirical investigation and expert knowledge and therefore the base- variables are ordinal scaled. The aggregation process takes place on the basis of a hierarchical structure. Finally, in order to render the use of the method more practical a software system on PC basis is developed and implemented.

Keeping waived tests simple.

PubMed

2004-01-01

Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

Identification of Ways to Improve Military Construction for Energy-Efficient Facilities.

DTIC Science & Technology

1987-12-01

inservice . Thus, it is necessary to control techniques, materials, and equip- S ment as part of the Military Construction, Army (MCA) process to ensure...Moreover, USACE often lacks proper test equipment and trained personnel at many construction sites. The 0 result is that acceptance testing often is...on a few diagnostic procedures. USACE quality assurance inspectors would be trained to do the tests. .-. Objectives 0 The overall objective of this

Improved latrine cleanliness through behaviour change and changes in quality of latrine construction: a longitudinal intervention study in rural Burundi.

PubMed

Mosler, Hans-Joachim; Sonego, Ina Lucia

2017-10-01

Latrine cleanliness increased in the intervention group compared to the control group (increase from 21 to 31 % of latrines classified as clean in intervention [N = 198] and decrease from 37 to 27 % in control [N = 91]). Improved habitual latrine cleaning lead to latrines being 3.5 times more likely to improve in observed latrine cleanliness (χ 2  = 16.36, p < .001) and so did improvements in quality of latrine construction, eg households that had installed a lid were 7.39 times more likely to have a cleaner latrine (χ 2  = 4.46, p < .05). Changes in psychosocial factors, namely forgetting, personal norm, satisfaction with cleanliness, explained much of the change in habitual latrine cleaning (adj. r 2  = .46). Behaviour change interventions targeting psychosocial factors and quality of latrine construction seem promising to ensure clean and hygienic latrines.

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

PubMed

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

2017-03-01

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

An investigation of automatic exposure control calibration for chest imaging with a computed radiography system.

PubMed

Moore, C S; Wood, T J; Avery, G; Balcam, S; Needler, L; Beavis, A W; Saunderson, J R

2014-05-07

The purpose of this study was to examine the use of three physical image quality metrics in the calibration of an automatic exposure control (AEC) device for chest radiography with a computed radiography (CR) imaging system. The metrics assessed were signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR) and mean effective noise equivalent quanta (eNEQm), all measured using a uniform chest phantom. Subsequent calibration curves were derived to ensure each metric was held constant across the tube voltage range. Each curve was assessed for its clinical appropriateness by generating computer simulated chest images with correct detector air kermas for each tube voltage, and grading these against reference images which were reconstructed at detector air kermas correct for the constant detector dose indicator (DDI) curve currently programmed into the AEC device. All simulated chest images contained clinically realistic projected anatomy and anatomical noise and were scored by experienced image evaluators. Constant DDI and CNR curves do not appear to provide optimized performance across the diagnostic energy range. Conversely, constant eNEQm and SNR do appear to provide optimized performance, with the latter being the preferred calibration metric given as it is easier to measure in practice. Medical physicists may use the SNR image quality metric described here when setting up and optimizing AEC devices for chest radiography CR systems with a degree of confidence that resulting clinical image quality will be adequate for the required clinical task. However, this must be done with close cooperation of expert image evaluators, to ensure appropriate levels of detector air kerma.

An investigation of automatic exposure control calibration for chest imaging with a computed radiography system

NASA Astrophysics Data System (ADS)

Moore, C. S.; Wood, T. J.; Avery, G.; Balcam, S.; Needler, L.; Beavis, A. W.; Saunderson, J. R.

2014-05-01

The purpose of this study was to examine the use of three physical image quality metrics in the calibration of an automatic exposure control (AEC) device for chest radiography with a computed radiography (CR) imaging system. The metrics assessed were signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR) and mean effective noise equivalent quanta (eNEQm), all measured using a uniform chest phantom. Subsequent calibration curves were derived to ensure each metric was held constant across the tube voltage range. Each curve was assessed for its clinical appropriateness by generating computer simulated chest images with correct detector air kermas for each tube voltage, and grading these against reference images which were reconstructed at detector air kermas correct for the constant detector dose indicator (DDI) curve currently programmed into the AEC device. All simulated chest images contained clinically realistic projected anatomy and anatomical noise and were scored by experienced image evaluators. Constant DDI and CNR curves do not appear to provide optimized performance across the diagnostic energy range. Conversely, constant eNEQm and SNR do appear to provide optimized performance, with the latter being the preferred calibration metric given as it is easier to measure in practice. Medical physicists may use the SNR image quality metric described here when setting up and optimizing AEC devices for chest radiography CR systems with a degree of confidence that resulting clinical image quality will be adequate for the required clinical task. However, this must be done with close cooperation of expert image evaluators, to ensure appropriate levels of detector air kerma.

Standardizing flow cytometric assays in long-term population-based studies

NASA Astrophysics Data System (ADS)

Melzer, Susanne; Bocsi, Jozsef; Tárnok, Attila

2015-03-01

Quantification of leukocyte subpopulations and characterization of antigen-expression pattern on the cellular surface can play an important role in diagnostics. The state of cellular immunology on the single-cell level was analyzed by polychromatic flow cytometry in a recent comparative study within the average Leipzig population (LIFE - Leipzig Research Centre for Civilization Diseases). Data of 1699 subjects were recorded over a long-time period of three years (in a total of 1126 days). To ensure compatibility of such huge data sets, quality-controls on many levels (stability of instrumentation, low intra-laboratory variance and reader independent data analysis) are essential. The LIFE study aims to analyze various cytometric pattern to reveal the relationship between the life-style, the environmental effects and the individual health. We therefore present here a multi-step quality control procedure for long-term comparative studies.

A Small RNA-Catalytic Argonaute Pathway Tunes Germline Transcript Levels to Ensure Embryonic Divisions

PubMed Central

Gerson-Gurwitz, Adina; Wang, Shaohe; Sathe, Shashank; Green, Rebecca; Yeo, Gene W.; Oegema, Karen; Desai, Arshad

2016-01-01

SUMMARY Multiple division cycles without growth are a characteristic feature of early embryogenesis. The female germline loads proteins and RNAs into oocytes to support these divisions, which lack many quality control mechanisms operating in somatic cells undergoing growth. Here we describe a small RNA-Argonaute pathway that ensures early embryonic divisions in C. elegans by employing catalytic slicing activity to broadly tune, instead of silence, germline gene expression. Misregulation of one target, a kinesin-13 microtubule depolymerase, underlies a major phenotype associated with pathway loss. Tuning of target transcript levels is guided by density of homologous small RNAs, whose generation must ultimately be related to target sequence. Thus, the tuning action of a small RNA-catalytic Argonaute pathway generates oocytes capable of supporting embryogenesis. We speculate that the specialized nature of germline chromatin led to emergence of small RNA-catalytic Argonaute pathways in the female germline as a post-transcriptional control layer to optimize oocyte composition. PMID:27020753

Automatic retinal interest evaluation system (ARIES).

PubMed

Yin, Fengshou; Wong, Damon Wing Kee; Yow, Ai Ping; Lee, Beng Hai; Quan, Ying; Zhang, Zhuo; Gopalakrishnan, Kavitha; Li, Ruoying; Liu, Jiang

2014-01-01

In recent years, there has been increasing interest in the use of automatic computer-based systems for the detection of eye diseases such as glaucoma, age-related macular degeneration and diabetic retinopathy. However, in practice, retinal image quality is a big concern as automatic systems without consideration of degraded image quality will likely generate unreliable results. In this paper, an automatic retinal image quality assessment system (ARIES) is introduced to assess both image quality of the whole image and focal regions of interest. ARIES achieves 99.54% accuracy in distinguishing fundus images from other types of images through a retinal image identification step in a dataset of 35342 images. The system employs high level image quality measures (HIQM) to perform image quality assessment, and achieves areas under curve (AUCs) of 0.958 and 0.987 for whole image and optic disk region respectively in a testing dataset of 370 images. ARIES acts as a form of automatic quality control which ensures good quality images are used for processing, and can also be used to alert operators of poor quality images at the time of acquisition.

Infection prevention and control practitioners: improving engagement.

PubMed

Aziz, Ann-Marie

Every healthcare worker plays a vital part in minimising the risk of cross infection. Infection prevention and control (IPC) practitioners have the skills and competencies to assist organisations in improving engagement among staff and play a vital part in achieving this. IPC practitioners have skills in clinical practice, education, research and leadership, and these skills ensure high-quality care for patients and support strategies for engaging staff. This article highlights how IPC practitioners' skills and competencies are required for preventing infection and improving staff engagement. Engaged staff generate positive outcomes for both patients and staff, which is a welcome result for all healthcare organisations.

Summary of development and recommendations for a quality assurance program for the procurement and manufacture of urban mass transit operating equipment and systems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

A viable quality program for the urban mass transit industry, and a management approach to ensure compliance with the program are outlined. Included are: (1) a set of guidelines for quality assurance to be imposed on transit authorities, and a management approach to ensure compliance with them; (2) a management approach to be used by the transit authorities (properties) for assuring compliance with the QA guidelines; and (3) quality assurance guidelines to be imposed by properties and umta for procurement of hardware and systems.

Detection Methodologies for Pathogen and Toxins: A Review.

PubMed

Alahi, Md Eshrat E; Mukhopadhyay, Subhas Chandra

2017-08-16

Pathogen and toxin-contaminated foods and beverages are a major source of illnesses, even death, and have a significant economic impact worldwide. Human health is always under a potential threat, including from biological warfare, due to these dangerous pathogens. The agricultural and food production chain consists of many steps such as harvesting, handling, processing, packaging, storage, distribution, preparation, and consumption. Each step is susceptible to threats of environmental contamination or failure to safeguard the processes. The production process can be controlled in the food and agricultural sector, where smart sensors can play a major role, ensuring greater food quality and safety by low cost, fast, reliable, and profitable methods of detection. Techniques for the detection of pathogens and toxins may vary in cost, size, and specificity, speed of response, sensitivity, and precision. Smart sensors can detect, analyse and quantify at molecular levels contents of different biological origin and ensure quality of foods against spiking with pesticides, fertilizers, dioxin, modified organisms, anti-nutrients, allergens, drugs and so on. This paper reviews different methodologies to detect pathogens and toxins in foods and beverages.

DRAFT METHODOLOGY FOR DERIVATION OF WATER ...

EPA Pesticide Factsheets

Development and body functions of many organisms are directed by the endocrine system. Endocrine Disrupting Chemicals (EDCs), are those exogenous (and endogenous) compounds that may interfere with this regulatory function because they may either mimic or suppress the action of the body’s natural hormones. Because these chemicals are increasingly present in the environment as a result of human activities and they only require tiny amounts to disrupt endocrine functions, EDCs may have major impacts on ecology and particularly aquatic life as evidenced by the abundance of field observations verified by both laboratory and controlled in situ experiments. The Clean Water Act § 304(a)(1) authorizes the Administrator to develop and publish criteria for water quality that are protective of aquatic life. Traditionally, ambient water quality criteria for the protection of aquatic life have been derived using the 1985 Guidelines (Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Life and Their Uses). These guidelines have comprehensive data requirements for toxicity tests using a variety of aquatic taxa, thus ensuring protection of the existing aquatic assemblage, and helping to ensure a goal of protecting and restoring “ecological integrity”. Some “Pharmaceuticals and Personal Care Products” (PPCPs), particularly those exhibiting endocrine disrupting activity, have two unique features, which distinguish them from

Implementation and utilization of a comprehensive information network in an integrated private not-for-profit regional health care system

NASA Astrophysics Data System (ADS)

Long, James M., III

1995-10-01

The capacity to access, integrate, and analyze demographic, financial, and clinical data within a regional health care system represents an opportunity to ensure and enhance clinical quality and to reduce costs in a carefully planned and controlled manner. Properly used, such capability should improve health care delivery for local populations and provide the institution with a level of integration of services achieved by few health care organizations. The Baptist Health System (BHS), based in Birmingham, Alabama, is currently standardizing operating procedures among its various components and implementing a comprehensive, enterprise-wide information network. Clinical quality improvement and case management are being promulgated throughout the enterprise using a continuum-of-care model developed internally. Having successfully completed a pilot project using teleconferences for core lectures in internal medicine between two large teaching hospitals, BHS is taking advantage of enterprise- wide teleconference capability using a combination of fiberoptic (T3) and standard digital telephone (T1) transmission to speed installation and reduce the cost of implementation into two office buildings and eleven hospitals. The information system will serve to prepare BHS for the advent of managed care and other anticipated changes in health care, while ensuring continued ability to deliver high quality, cost-effective medical and health-related services.

Early warning of changing drinking water quality by trend analysis.

PubMed

Tomperi, Jani; Juuso, Esko; Leiviskä, Kauko

2016-06-01

Monitoring and control of water treatment plants play an essential role in ensuring high quality drinking water and avoiding health-related problems or economic losses. The most common quality variables, which can be used also for assessing the efficiency of the water treatment process, are turbidity and residual levels of coagulation and disinfection chemicals. In the present study, the trend indices are developed from scaled measurements to detect warning signs of changes in the quality variables of drinking water and some operating condition variables that strongly affect water quality. The scaling is based on monotonically increasing nonlinear functions, which are generated with generalized norms and moments. Triangular episodes are classified with the trend index and its derivative. Deviation indices are used to assess the severity of situations. The study shows the potential of the described trend analysis as a predictive monitoring tool, as it provides an advantage over the traditional manual inspection of variables by detecting changes in water quality and giving early warnings.

Achieving fertility control through woman’s autonomy and access to maternal healthcare: Are we on track? In-depth analysis of PDHS-2012-13

PubMed Central

Hassan, Sehar-un-Nisa; Siddiqui, Salma; Mahmood, Ayeshah

2015-01-01

Background and Objective: Fertility control preferences and maternal healthcare have recently become a major concern for developing nations with evidence suggesting that low fertility control rates and poor maternal healthcare are among major obstructions in ensuring health and social status for women. Our objective was toanalyze the factors that influence women’s autonomy, access to maternal healthcare, and fertility control preferences in Pakistan. Methods: Data consisted of 11,761 ever-married women of ages 15-49 years from PDHS, 2012-13. Variables included socio-demographics, women’s autonomy, fertility control preferences and access to maternal healthcare. Results: Findings from multivariate analysis showed that women’s younger age, having less than three number of children and independent or joint decision-making (indicators of high autonomy) remained the most significant predictors for access to better quality maternal healthcare and better fertility control preferences when other variables were controlled. Conclusion: Women’s access to good quality maternal health care and fertility control preferences are directly and indirectly influenced by their demographic characteristics and decision-making patterns in domestic affairs. PMID:26870096

Evaluating Software Assurance Knowledge and Competency of Acquisition Professionals

DTIC Science & Technology

2014-10-01

of ISO 12207 -2008, both internationally and in the United States [7]. That standard documents a comprehensive set of activities and supporting...grows, organizations must ensure that their procurement agents acquire high quality, secure software. ISO 12207 and the Software Assurance Competency...cyberattacks grows, organizations must ensure that their procurement agents acquire high quality, secure software. ISO 12207 and the Software Assurance

Uncovering Predictors of Disagreement: Ensuring the Quality of Expert Ratings

ERIC Educational Resources Information Center

Hoth, Jessica; Schwarz, Björn; Kaiser, Gabriele; Busse, Andreas; König, Johannes; Blömeke, Sigrid

2016-01-01

Rating scales are a popular item format used in many types of assessments. Yet, defining which rating is correct often represents a challenge. Using expert ratings as benchmarks is one approach to ensuring the quality of a rating instrument. In this paper, such expert ratings are analyzed in detail taking a video-based test instrument of teachers'…

Quality-assurance plan for water-resources activities of the U.S. Geological Survey in Idaho

USGS Publications Warehouse

Packard, F.A.

1996-01-01

To ensure continued confidence in its products, the Water Resources Division of the U.S. Geological Survey implemented a policy that all its scientific work be performed in accordance with a centrally managed quality-assurance program. This report establishes and documents a formal policy for current (1995) quality assurance within the Idaho District of the U.S. Geological Survey. Quality assurance is formalized by describing district organization and operational responsibilities, documenting the district quality-assurance policies, and describing district functions. The districts conducts its work through offices in Boise, Idaho Falls, Twin Falls, Sandpoint, and at the Idaho National Engineering Laboratory. Data-collection programs and interpretive studies are conducted by two operating units, and operational and technical assistance is provided by three support units: (1) Administrative Services advisors provide guidance on various personnel issues and budget functions, (2) computer and reports advisors provide guidance in their fields, and (3) discipline specialists provide technical advice and assistance to the district and to chiefs of various projects. The district's quality-assurance plan is based on an overall policy that provides a framework for defining the precision and accuracy of collected data. The plan is supported by a series of quality-assurance policy statements that describe responsibilities for specific operations in the district's program. The operations are program planning; project planning; project implementation; review and remediation; data collection; equipment calibration and maintenance; data processing and storage; data analysis, synthesis, and interpretation; report preparation and processing; and training. Activities of the district are systematically conducted under a hierarchy of supervision an management that is designed to ensure conformance with Water Resources Division goals quality assurance. The district quality-assurance plan does not describe detailed technical activities that are commonly termed "quality-control procedures." Instead, it focuses on current policies, operations, and responsibilities that are implemented at the management level. Contents of the plan will be reviewed annually and updated as programs and operations change.

Pre-rigor temperature control of Chinese yellow cattle carcasses to 12-18 °C during chilling improves beef tenderness.

PubMed

Liu, Yuqing; Mao, Yanwei; Zhang, Yimin; Liang, Rongrong; Wang, Renhuan; Zhu, Lixian; Meng, Xianyong; Luo, Xin

2015-02-01

This study evaluates the effects of pre-rigor temperature control on quality traits of Chinese yellow cattle M. longissimus lumborum (LL). One stepwise chilling (SC) treatment was used on one half-carcass, involved a fast chilling (-11 ± 1 °C;0.5 m/s) for 2h, then the refrigeration was stopped to hold a core temperature of 12-18 °C until 10h postmortem, followed by a 1 ± 1 °C chilling (0.5 m/s) to 48h postmortem. The other half-carcass was conventional chilled at 1 ± 1 °C (0.5 m/s) until 48h as control chilling (CC). Quality attributes were evaluated at 1, 7 and 14 days. The SC treatment resulted in decreased WBSF and increased myofibril fragmentation index compared with control. SC-treated LL at 7d postmortem had a lower WBSF than those of CC-treated at 14d. This pre-rigor temperature controlled chilling is a realistic alternative for the beef industry in China to ensure adequate tenderness and shorten aging time.

Overview of the Nordic Seas CARINA data and salinity measurements

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

Olsen, Are; Key, Robert; Jeansson, Emil

2009-01-01

Water column data of carbon and carbon relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruises in the Arctic, Atlantic, and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon IN the Atlantic). The data have been subject to rigorous quality control (QC) in order to ensure highest possible quality and consistency. The data for most of the parameters included were examined in order to quantify systematic biases in the reported values, i.e. secondary quality control. Significant biases have been corrected for in the data products, i.e. the three merged files with measured, calculatedmore » and interpolated values for each of the three CARINA regions; the Arctic Mediterranean Seas (AMS), the Atlantic (ATL) and the Southern Ocean (SO).With the adjustments the CARINA database is consistent both internally as well as with GLODAP (Key et al., 2004) and is suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation. The Arctic Mediterranean Seas include the Arctic Ocean and the Nordic Seas, and the quality control was carried out separately in these two areas. This contribution provides an overview of the CARINA data from the Nordic Seas and summaries the findings of the QC of the salinity data. One cruise had salinity data that were of questionable quality, and these have been removed from the data product. An evaluation of the consistency of the quality controlled salinity data suggests that they are consistent to at least 0.005.« less

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

PubMed

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

2014-07-01

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

Assessment of microbiological quality of retail fresh sushi from selected sources in Norway.

PubMed

Hoel, Sunniva; Mehli, Lisbeth; Bruheim, Torkjel; Vadstein, Olav; Jakobsen, Anita Nordeng

2015-05-01

Retail fresh sushi is gaining popularity in Europe. This study was conducted to investigate the microbiological quality of selected samples of fresh sushi with a shelf life of 2 to 3 days offered as complete meals in Norwegian supermarkets. Analysis of aerobic plate counts in 58 sushi samples from three producers revealed large variations in microbiological quality, and 48% of the analyzed sushi boxes were rated as unsatisfactory (> 6.0 log CFU/g). Mesophilic Aeromonas spp. was detected in 71% of the samples. In a follow-up study, we collected products and raw materials directly from the production facility of one producer and observed a significant decrease (P < 0.01) in aerobic plate counts compared with the initial sampling. The observed difference between products purchased in stores compared with those collected directly from the factory suggests that poor temperature control during distribution and display in stores leads to reduced microbiological quality. Microbiological analysis of the sushi ingredients revealed that potentially pathogenic bacteria such as mesophilic Aeromonas spp. or bacteria belonging to the Enterobacteriaceae can be introduced into sushi through both raw vegetables and fish. The results highlight the importance of high quality ingredients and proper temperature control to ensure stable quality and safety of these food products.

[Inter-and intra-operator variability in the analysis of semen parameters: results from a quality control program].

PubMed

Daoud, Salima; Chakroun-Feki, Nozha; Sellami, Afifa; Ammar-Keskes, Leila; Rebai, Tarek

2016-01-01

Semen analysis is a key part of male infertility investigation. The necessity of quality management implementation in the andrology laboratory has been recognized in order to ensure the reliability of its results. The aim of this study was to evaluate intra- and inter-individual variability in the assessment of semen parameters in our laboratory through a quality control programme. Four participants from the laboratory with different experience levels have participated in this study. Semen samples of varying quality were assessed for sperm motility, concentration and morphology and the results were used to evaluate inter-participant variability. In addition, replicates of each semen sample were analyzed to determine intra-individual variability for semen parameters analysis. The average values of inter-participant coefficients of variation for sperm motility, concentration and morphology were 12.8%, 19.8% and 48.9% respectively. The mean intra-participant coefficients of variation were, respectively, 6.9%, 12.3% and 42.7% for sperm motility, concentration and morphology. Despite some random errors of under- or overestimation, the overall results remained within the limits of acceptability for all participants. Sperm morphology assessment was particularly influenced by the participant's level of experience. The present data emphasize the need for appropriate training of the laboratory staff and for regular participation in internal quality control programmes in order to improve the reliability of laboratory results.

Announcement—guidance document for acquiring reliable data in ecological restoration projects

USGS Publications Warehouse

Stapanian, Martin A.; Rodriguez, Karen; Lewis, Timothy E.; Blume, Louis; Palmer, Craig J.; Walters, Lynn; Schofield, Judith; Amos, Molly M.; Bucher, Adam

2016-01-01

The Laurentian Great Lakes are undergoing intensive ecological restoration in Canada and the United States. In the United States, an interagency committee was formed to facilitate implementation of quality practices for federally funded restoration projects in the Great Lakes basin. The Committee's responsibilities include developing a guidance document that will provide a common approach to the application of quality assurance and quality control (QA/QC) practices for restoration projects. The document will serve as a “how-to” guide for ensuring data quality during each aspect of ecological restoration projects. In addition, the document will provide suggestions on linking QA/QC data with the routine project data and hints on creating detailed supporting documentation. Finally, the document will advocate integrating all components of the project, including QA/QC applications, into an overarching decision-support framework. The guidance document is expected to be released by the U.S. EPA Great Lakes National Program Office in 2017.

PREPARE: guidelines for planning animal research and testing

PubMed Central

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2017-01-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE. PMID:28771074

PREPARE: guidelines for planning animal research and testing.

PubMed

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2018-04-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE .

Long-Term Ecological Monitoring Field Sampling Plan for 2007

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

T. Haney

2007-07-31

This field sampling plan describes the field investigations planned for the Long-Term Ecological Monitoring Project at the Idaho National Laboratory Site in 2007. This plan and the Quality Assurance Project Plan for Waste Area Groups 1, 2, 3, 4, 5, 6, 7, 10, and Removal Actions constitute the sampling and analysis plan supporting long-term ecological monitoring sampling in 2007. The data collected under this plan will become part of the long-term ecological monitoring data set that is being collected annually. The data will be used t determine the requirements for the subsequent long-term ecological monitoring. This plan guides the 2007more » investigations, including sampling, quality assurance, quality control, analytical procedures, and data management. As such, this plan will help to ensure that the resulting monitoring data will be scientifically valid, defensible, and of known and acceptable quality.« less

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

PubMed Central

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial. PMID:28163667

Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

PubMed

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.

Fuzzy logic controller to improve powerline communication

NASA Astrophysics Data System (ADS)

Tirrito, Salvatore

2015-12-01

The Power Line Communications (PLC) technology allows the use of the power grid in order to ensure the exchange of data information among devices. This work proposes an approach, based on Fuzzy Logic, that dynamically manages the amplitude of the signal, with which each node transmits, by processing the master-slave link quality measured and the master-slave distance. The main objective of this is to reduce both the impact of communication interferences induced and power consumption.

Brain Immune Interactions as the Basis of Gulf War Illness: Gulf War Illness Consortium (GWIC)

DTIC Science & Technology

2015-10-01

August to train all clinical staff and to ensure proper quality control measures are in place for the clinical studies. This has been followed up by...clinical and preclinical studies Training for researchers and clinical staff was completed at in-person meeting in Boston in August 2014 and continued to...Catechol-O- methyl transferase ( COMT ). COMT is associated with synaptic catecholamine neurotransmitters. COMT helps regulate cortical dopamine in the

Audit Oversight: Quality Control System at U.S. Special Operations Command Inspector General Audit Division

DTIC Science & Technology

2002-08-21

The Audit Division provides the Commander, U.S. Special Operations Command (USSOCOM) with professional auditing services to safeguard, account for...and ensure the proper use of special operations forces assets in accomplishing the USSOCOM mission. The Audit Division reports to the USSOCOM Inspector...U.S. Army Special Operations Command, Naval Special Warfare Command, and the Joint Special Operations Command. Appendix A contains a summary of the Audit Division policy and procedures.

Radio astronomy Explorer-B postlaunch attitude operations analysis

NASA Technical Reports Server (NTRS)

Werking, R. D.; Berg, R.; Brokke, K.; Hattox, T.; Lerner, G.; Stewart, D.; Williams, R.

1974-01-01

The attitude support activities of the Radio Astronomy Explorer-B are reported. The performance of the spacecraft hardware and software are discussed along with details of the mission events, from launch through main boom deployment. Reproductions of displays are presented which were used during support activities. The interactive graphics proved the support function by providing the quality control necessary to ensure mission success in an environment where flight simulated ground testing of spacecraft hardware cannot be performed.

Temperature Control and Numerical Analysis for Mass Concrete Pile Cap of Hai-huang Bridge

NASA Astrophysics Data System (ADS)

Shi, Han; Hao, Yang; Yong-liang, Wang

2018-05-01

In order to study the heat of hydration in massive concrete, this paper takes Hai-huang bridge for engineering background and uses the finite element analysis software of FEA to analyze the heat of hydration effect of the cushion cap. Comparing the measured data with the theory data, the results showed that the concrete crack was controlled effectively and ensure the construction quality by adopted reasonable temperature control measures. The results of the research prove that the measured data was consistent with calculation data, and it proves the accuracy of the finite element analysis. Finally, the study provides certain reference and guiding significance for similar project.

Comparative tests of bench equipment for fuel control system testing of gas-turbine engine

NASA Astrophysics Data System (ADS)

Shendaleva, E. V.

2018-04-01

The relevance of interlaboratory comparative researches is confirmed by attention of world metrological community to this field of activity. Use of the interlaboratory comparative research methodology not only for single gages collation, but also for bench equipment complexes, such as modeling stands for fuel control system testing of gas-turbine engine, is offered. In this case a comparative measure of different bench equipment will be the control fuel pump. Ensuring traceability of measuring result received at test benches of various air enterprises, development and introduction of national standards to practice of bench tests and, eventually, improvement of quality and safety of a aircraft equipment is result of this approach.

[Tasks and duties of veterinary reference laboratories for food borne zoonoses].

PubMed

Ellerbroek, Lüppo; Alter, T; Johne, R; Nöckler, K; Beutin, L; Helmuth, R

2009-02-01

Reference laboratories are of central importance for consumer protection. Field expertise and high scientific competence are basic requirements for the nomination of a national reference laboratory. To ensure a common approach in the analysis of zoonotic hazards, standards have been developed by the reference laboratories together with national official laboratories on the basis of Art. 33 of Directive (EG) No. 882/2004. Reference laboratories function as arbitrative boards in the case of ambivalent or debatable results. New methods for detection of zoonotic agents are developed and validated to provide tools for analysis, e. g., in legal cases, if results from different parties are disputed. Besides these tasks, national reference laboratories offer capacity building and advanced training courses and control the performance of ring trials to ensure consistency in the quality of analyses in official laboratories. All reference laboratories work according to the ISO standard 17025 which defines the grounds for strict laboratory quality rules and in cooperation with the respective Community Reference Laboratories (CRL). From the group of veterinary reference laboratories for food-borne zoonoses, the national reference laboratories are responsible for Listeria monocytogenes, for Campylobacter, for the surveillance and control of viral and bacterial contamination of bivalve molluscs, for E. coli, for the performance of analysis and tests on zoonoses (Salmonella), and from the group of parasitological zoonotic agents, the national reference laboratory for Trichinella.

Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial.

PubMed

Timmermans, Catherine; Doffagne, Erik; Venet, David; Desmet, Lieven; Legrand, Catherine; Burzykowski, Tomasz; Buyse, Marc

2016-01-01

Data quality may impact the outcome of clinical trials; hence, there is a need to implement quality control strategies for the data collected. Traditional approaches to quality control have primarily used source data verification during on-site monitoring visits, but these approaches are hugely expensive as well as ineffective. There is growing interest in central statistical monitoring (CSM) as an effective way to ensure data quality and consistency in multicenter clinical trials. CSM with SMART™ uses advanced statistical tools that help identify centers with atypical data patterns which might be the sign of an underlying quality issue. This approach was used to assess the quality and consistency of the data collected in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial, involving 1495 patients across 232 centers in Japan. In the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial, very few atypical data patterns were found among the participating centers, and none of these patterns were deemed to be related to a quality issue that could significantly affect the outcome of the trial. CSM can be used to provide a check of the quality of the data from completed multicenter clinical trials before analysis, publication, and submission of the results to regulatory agencies. It can also form the basis of a risk-based monitoring strategy in ongoing multicenter trials. CSM aims at improving data quality in clinical trials while also reducing monitoring costs.

Elements That Contribute to Healthy Building Design

PubMed Central

Loftness, Vivian; Hakkinen, Bert; Adan, Olaf; Nevalainen, Aino

2007-01-01

Background The elements that contribute to a healthy building are multifactorial and can be discussed from different perspectives. Objectives We present three viewpoints of designing a healthy building: the importance of sustainable development, the role of occupants for ensuring indoor air quality, and ongoing developments related to indoor finishes with low chemical emissions and good fungal resistance. Discussion Sustainable design rediscovers the social, environmental, and technical values of pedestrian and mixed-use communities, using existing infrastructures including “main streets” and small-town planning principles and recapturing indoor–outdoor relationships. This type of design introduces nonpolluting materials and assemblies with lower energy requirements and higher durability and recyclability. Building occupants play a major role in maintaining healthy indoor environments, especially in residences. Contributors to indoor air quality include cleaning habits and other behaviors; consumer products, furnishings, and appliances purchases, as well as where and how the occupants use them. Certification of consumer products and building materials as low-emitting products is a primary control measure for achieving good indoor air quality. Key products in this respect are office furniture, flooring, paints and coatings, adhesives and sealants, wall coverings, wood products, textiles, insulation, and cleaning products. Finishing materials play a major role in the quality of indoor air as related to moisture retention and mold growth. Conclusions Sustainable design emphasizes the needs of infrastructure, lower energy consumption, durability, and recyclability. To ensure good indoor air quality, the product development for household use should aim to reduce material susceptibility to contaminants such as mold and should adopt consumer-oriented product labeling. PMID:17589608

Ensuring Quality in Early Childhood Education and Care: The Case of Turkey

ERIC Educational Resources Information Center

Gol-Guven, Mine

2018-01-01

With increasing numbers of women entering the workforce in Turkey, efforts have been made to provide services for children and their families. In 2016, 33.2% of 3- to 5-year olds in Turkey were attending preschool. This figure is lower than that of most OECD countries, but the important point is to increase the attendance rate by ensuring quality.…

Next level of board accountability in health care quality.

PubMed

Pronovost, Peter J; Armstrong, C Michael; Demski, Renee; Peterson, Ronald R; Rothman, Paul B

2018-03-19

Purpose The purpose of this paper is to offer six principles that health system leaders can apply to establish a governance and management system for the quality of care and patient safety. Design/methodology/approach Leaders of a large academic health system set a goal of high reliability and formed a quality board committee in 2011 to oversee quality and patient safety everywhere care was delivered. Leaders of the health system and every entity, including inpatient hospitals, home care companies, and ambulatory services staff the committee. The committee works with the management for each entity to set and achieve quality goals. Through this work, the six principles emerged to address management structures and processes. Findings The principles are: ensure there is oversight for quality everywhere care is delivered under the health system; create a framework to organize and report the work; identify care areas where quality is ambiguous or underdeveloped (i.e. islands of quality) and work to ensure there is reporting and accountability for quality measures; create a consolidated quality statement similar to a financial statement; ensure the integrity of the data used to measure and report quality and safety performance; and transparently report performance and create an explicit accountability model. Originality/value This governance and management system for quality and safety functions similar to a finance system, with quality performance documented and reported, data integrity monitored, and accountability for performance from board to bedside. To the authors' knowledge, this is the first description of how a board has taken this type of systematic approach to oversee the quality of care.

The association between the physical environment and the well-being of older people in residential care facilities: A multilevel analysis.

PubMed

Nordin, Susanna; McKee, Kevin; Wijk, Helle; Elf, Marie

2017-12-01

To investigate the associations between the quality of the physical environment and the psychological and social well-being of older people living in residential care facilities. Many older people in care facilities have cognitive and physical frailties and are at risk of experiencing low levels of well-being. High-quality physical environments can support older people as frailty increases and promote their well-being. Although the importance of the physical environment for residents' well-being is recognized, more research is needed. A cross-sectional survey of 20 care facilities from each of which 10 residents were sampled. As the individual resident data were nested in the facilities, a multilevel analysis was conducted. Data were collected during 2013 and 2014. The care facilities were purposely sampled to ensure a high level of variation in their physical characteristics. Residents' demographic and health data were collected via medical records and interviews. Residents' well-being and perceived quality of care were assessed via questionnaires and interviews. Environmental quality was assessed with a structured observational instrument. Multilevel analysis indicated that cognitive support in the physical environment was associated with residents' social well-being, after controlling for independence and perceived care quality. However, no significant association was found between the physical environment and residents' psychological well-being. Our study demonstrates the role of the physical environment for enhancing the social well-being of frail older people. Professionals and practitioners involved in the design of care facilities have a responsibility to ensure that such facilities meet high-quality specifications. © 2017 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Ensure preparation and capsule endoscopy: A two-center prospective study

PubMed Central

Niv, Eva; Ovadia, Baruch; Ron, Yulia; Santo, Ervin; Mahajna, Elisabeth; Halpern, Zamir; Fireman, Zvi

2013-01-01

AIM: To compare small bowel (SB) cleanliness and capsule endoscopy (CE) image quality following Ensure®, polyethylene glycol (PEG) and standard preparations. METHODS: A preparation protocol for CE that is both efficacious and acceptable to patients remains elusive. Considering the physiological function of the SB as a site for the digestion and absorption of food and not as a stool reservoir, preparation consisting of a liquid, fiber-free formula ingested one day before a CE study might have an advantage over other kinds of preparations. We conducted a prospective, blind-to-preparation, two-center study that compared four types of preparations. The participants’ demographic and clinical data were collected. Gastric and SB transit times were calculated. The presence of bile in the duodenum was scored by a single, blinded-to-preparation gastroenterologist expert in CE, as was cleanliness within the proximal, middle and distal part of the SB. A four-point scale was used (grade 1 = no bile or residue, grade 4 ≥ 90% of lumen full of bile or residual material). RESULTS: The 198 consecutive patients who were referred to CE studies due to routine medical reasons were divided into four groups. They all observed a 12-h overnight fast before undergoing CE. Throughout the 24 h preceding the fast, control group 1 (n = 45 patients) ate light unrestricted meals, control group 2 (n = 81) also ate light meals but free of fruits and vegetables, the PEG group (n = 50) ate unrestricted light meals and ingested the PEG preparation, and the Ensure group (n = 22) ingested only the Ensure formula. Preparation with Ensure improved the visualization of duodenal mucosa (a score of 1.76) by decreasing the bile content compared to preparation with PEG (a score of 2.9) (P = 0.053). Overall, as expected, there was less residue and stool in the proximal part of the SB than in the middle and distal parts in all groups. The total score of cleanliness throughout the length of the SB showed some benefit for Ensure (a score of 1.8) over control group 2 (a score of 2) (P = 0.06). The cleanliness grading of the proximal and distal parts of the SB was similar in all four groups (P = 0.6 for both). The cleanliness in the middle part of the SB in the PEG (a score of 1.8) and Ensure groups (a score of 1.7) was equally better than that of control group 2 (a score of 2.1) (P = 0.057 and P = 0.07, respectively). All 50 PEG patients had diarrhea as an anticipated side effect, compared with only one patient in the Ensure group. CONCLUSION: Preparation with Ensure, a liquid, fiber-free formula has advantages over standard and PEG preparations, with significantly fewer side effects than PEG. PMID:23483023

Analysis and experimental evaluation of shunt active power filter for power quality improvement based on predictive direct power control.

PubMed

Aissa, Oualid; Moulahoum, Samir; Colak, Ilhami; Babes, Badreddine; Kabache, Nadir

2017-10-12

This paper discusses the use of the concept of classical and predictive direct power control for shunt active power filter function. These strategies are used to improve the active power filter performance by compensation of the reactive power and the elimination of the harmonic currents drawn by non-linear loads. A theoretical analysis followed by a simulation using MATLAB/Simulink software for the studied techniques has been established. Moreover, two test benches have been carried out using the dSPACE card 1104 for the classic and predictive DPC control to evaluate the studied methods in real time. Obtained results are presented and compared in this paper to confirm the superiority of the predictive technique. To overcome the pollution problems caused by the consumption of fossil fuels, renewable energies are the alternatives recommended to ensure green energy. In the same context, the tested predictive filter can easily be supplied by a renewable energy source that will give its impact to enhance the power quality.

Design of modular control system for grain dryers

NASA Astrophysics Data System (ADS)

He, Gaoqing; Liu, Yanhua; Zu, Yuan

In order to effectively control the temperature of grain drying bin, grain ,air outlet as well as the grain moisture, it designed the control system of 5HCY-35 which is based on MCU to adapt to all grains drying conditions, high drying efficiency, long life usage and less manually. The system includes: the control module of the constant temperature and the temperature difference control in drying bin, the constant temperature control of heating furnace, on-line testing of moisture, variety of grain-circulation speed control and human-computer interaction interface. Spatial curve simulation, which takes moisture as control objectives, controls the constant temperature and the temperature difference in drying bin according to preset parameter by the user or a list to reduce the grains explosive to ensure the seed germination percentage. The system can realize the intelligent control of high efficiency and various drying, the good scalability and the high quality.

Taguchi's off line method and Multivariate loss function approach for quality management and optimization of process parameters -A review

NASA Astrophysics Data System (ADS)

Bharti, P. K.; Khan, M. I.; Singh, Harbinder

2010-10-01

Off-line quality control is considered to be an effective approach to improve product quality at a relatively low cost. The Taguchi method is one of the conventional approaches for this purpose. Through this approach, engineers can determine a feasible combination of design parameters such that the variability of a product's response can be reduced and the mean is close to the desired target. The traditional Taguchi method was focused on ensuring good performance at the parameter design stage with one quality characteristic, but most products and processes have multiple quality characteristics. The optimal parameter design minimizes the total quality loss for multiple quality characteristics. Several studies have presented approaches addressing multiple quality characteristics. Most of these papers were concerned with maximizing the parameter combination of signal to noise (SN) ratios. The results reveal the advantages of this approach are that the optimal parameter design is the same as the traditional Taguchi method for the single quality characteristic; the optimal design maximizes the amount of reduction of total quality loss for multiple quality characteristics. This paper presents a literature review on solving multi-response problems in the Taguchi method and its successful implementation in various industries.

Teacher Preparation: Ensuring a Quality Teacher in Every Classroom. Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, Second Session on Examining Teacher Preparation, Focusing on Ensuring a Quality Teacher in Every Classroom (March 25, 2014). Senate Hearing 113-828

ERIC Educational Resources Information Center

US Senate, 2016

2016-01-01

This is the seventh in a series of hearings to inform this committee's reauthorization of the Higher Education Act. The focus of this hearing, teacher preparation, is profoundly important for all students, from the very youngest to adult students. Study after study shows that teacher quality is the decisive in-school factor in boosting student…

45 CFR 261.62 - What must a State do to verify the accuracy of its work participation information?

Code of Federal Regulations, 2012 CFR

2012-10-01

... ensure a consistent measurement of the work participation rates, including the quality assurance... work participation information? 261.62 Section 261.62 Public Welfare Regulations Relating to Public..., DEPARTMENT OF HEALTH AND HUMAN SERVICES ENSURING THAT RECIPIENTS WORK How Do We Ensure the Accuracy of Work...

45 CFR 261.62 - What must a State do to verify the accuracy of its work participation information?

Code of Federal Regulations, 2011 CFR

2011-10-01

... ensure a consistent measurement of the work participation rates, including the quality assurance... work participation information? 261.62 Section 261.62 Public Welfare Regulations Relating to Public..., DEPARTMENT OF HEALTH AND HUMAN SERVICES ENSURING THAT RECIPIENTS WORK How Do We Ensure the Accuracy of Work...

45 CFR 261.62 - What must a State do to verify the accuracy of its work participation information?

Code of Federal Regulations, 2013 CFR

2013-10-01

... ensure a consistent measurement of the work participation rates, including the quality assurance... work participation information? 261.62 Section 261.62 Public Welfare Regulations Relating to Public..., DEPARTMENT OF HEALTH AND HUMAN SERVICES ENSURING THAT RECIPIENTS WORK How Do We Ensure the Accuracy of Work...

45 CFR 261.62 - What must a State do to verify the accuracy of its work participation information?

Code of Federal Regulations, 2014 CFR

2014-10-01

... ensure a consistent measurement of the work participation rates, including the quality assurance... work participation information? 261.62 Section 261.62 Public Welfare Regulations Relating to Public..., DEPARTMENT OF HEALTH AND HUMAN SERVICES ENSURING THAT RECIPIENTS WORK How Do We Ensure the Accuracy of Work...

Quality and Safety in Health Care, Part IV: Quality and Cancer Care.

PubMed

Harolds, Jay A

2015-11-01

The 1999 Institute of Medicine report Ensuring Quality Cancer Care discussed the difference between the actual cancer care received in the United States and the care that the patients should get, as well as some points to consider in delivering optimum care. In 2012, a follow-up review article in the journal Cancer entitled "Ensuring quality cancer care" indicated that there had been some interval progress, but more are needed to be done. The 2013 Institute of Medicine report Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis indicated that there are continuing major problems with cancer care and that they advocated a national system of quality reporting and a major information technology system to capture and help assess the data.

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

Use of artificial intelligence in the production of high quality minced meat

NASA Astrophysics Data System (ADS)

Kapovsky, B. R.; Pchelkina, V. A.; Plyasheshnik, P. I.; Dydykin, A. S.; Lazarev, A. A.

2017-09-01

A design for an automatic line for minced meat production according to new production technology based on an innovative meat milling method is proposed. This method allows the necessary degree of raw material comminution at the stage of raw material preparation to be obtained, which leads to production intensification due to the traditional meat mass comminution equipment being unnecessary. To ensure consistent quality of the product obtained, the use of on-line automatic control of the technological process for minced meat production is envisaged. This system has been developed using artificial intelligence methods and technologies. The system is trainable during the operation process, adapts to changes in processed raw material characteristics and to external impacts that affect the system operation, and manufactures meat shavings with minimal dispersion of the typical particle size. The control system includes equipment for express analysis of the chemical composition of the minced meat and its temperature after comminution. In this case, the minced meat production process can be controlled strictly as a function of time, which excludes subjective factors for assessing the degree of finished product readiness. This will allow finished meat products with consistent, targeted high quality to be produced.

Purification of High Molecular Weight Genomic DNA from Powdery Mildew for Long-Read Sequencing.

PubMed

Feehan, Joanna M; Scheibel, Katherine E; Bourras, Salim; Underwood, William; Keller, Beat; Somerville, Shauna C

2017-03-31

The powdery mildew fungi are a group of economically important fungal plant pathogens. Relatively little is known about the molecular biology and genetics of these pathogens, in part due to a lack of well-developed genetic and genomic resources. These organisms have large, repetitive genomes, which have made genome sequencing and assembly prohibitively difficult. Here, we describe methods for the collection, extraction, purification and quality control assessment of high molecular weight genomic DNA from one powdery mildew species, Golovinomyces cichoracearum. The protocol described includes mechanical disruption of spores followed by an optimized phenol/chloroform genomic DNA extraction. A typical yield was 7 µg DNA per 150 mg conidia. The genomic DNA that is isolated using this procedure is suitable for long-read sequencing (i.e., > 48.5 kbp). Quality control measures to ensure the size, yield, and purity of the genomic DNA are also described in this method. Sequencing of the genomic DNA of the quality described here will allow for the assembly and comparison of multiple powdery mildew genomes, which in turn will lead to a better understanding and improved control of this agricultural pathogen.

A Rotatable Quality Control Phantom for Evaluating the Performance of Flat Panel Detectors in Imaging Moving Objects.

PubMed

Haga, Yoshihiro; Chida, Koichi; Inaba, Yohei; Kaga, Yuji; Meguro, Taiichiro; Zuguchi, Masayuki

2016-02-01

As the use of diagnostic X-ray equipment with flat panel detectors (FPDs) has increased, so has the importance of proper management of FPD systems. To ensure quality control (QC) of FPD system, an easy method for evaluating FPD imaging performance for both stationary and moving objects is required. Until now, simple rotatable QC phantoms have not been available for the easy evaluation of the performance (spatial resolution and dynamic range) of FPD in imaging moving objects. We developed a QC phantom for this purpose. It consists of three thicknesses of copper and a rotatable test pattern of piano wires of various diameters. Initial tests confirmed its stable performance. Our moving phantom is very useful for QC of FPD images of moving objects because it enables visual evaluation of image performance (spatial resolution and dynamic range) easily.

METHOD 544. DETERMINATION OF MICROCYSTINS AND ...

EPA Pesticide Factsheets

Method 544 is an accurate and precise analytical method to determine six microcystins (including MC-LR) and nodularin in drinking water using solid phase extraction and liquid chromatography tandem mass spectrometry (SPE-LC/MS/MS). The advantage of this SPE-LC/MS/MS is its sensitivity and ability to speciate the microcystins. This method development task establishes sample preservation techniques, sample concentration and analytical procedures, aqueous and extract holding time criteria and quality control procedures. Draft Method 544 undergone a multi-laboratory verification to ensure other laboratories can implement the method and achieve the quality control measures specified in the method. It is anticipated that Method 544 may be used in UCMR 4 to collect nationwide occurrence data for selected microcystins in drinking water. The purpose of this research project is to develop an accurate and precise analytical method to concentrate and determine selected MCs and nodularin in drinking water.

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

PubMed

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

2017-09-01

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

Developmental Scientist | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Developmental Scientist will: Provide support and advisement to the development of the T Cell receptor gene therapy protocols. Establishes, implements and maintains standardized processes and assesses performance to make recommendations for improvement. Provides support and guidance to the cellular therapy or vector production facilities at the NIH Clinical Center engaged in the manufacture of patient-specific therapies. Manufactures cellular therapy products for human use. Develops and manufactures lentiviral and/or retroviral vectors. Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance. Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines. Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer. Serves as a leader/mentor to administrative staff and prepares employee performance evaluations. Develops and implements procedures/programs to ensure effective and efficient business and operational processes. Identifies potential bottlenecks in upcoming development processes and works with team members and senior management for resolution. Analyzes and tracks initiatives and contracts. Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, laboratory and office supplies to ensure compliance with appropriate government regulations. Coordinates the administrative, fiscal, contractual, and quality aspects of all projects. Ensures that internal budgets, schedules and performance requirements are met. Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available. Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted. Regularly interacts with senior or executive management both internally and externally, on matters concerning several functional areas such as operations, quality control and quality assurance. Participates in planning facility or operations modifications, upgrades and renovations. Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control. Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads and evaluating overall performance. This position is located in Bethesda, Maryland.

The quality of our Nation's waters: Water quality in principal aquifers of the United States, 1991-2010

USGS Publications Warehouse

DeSimone, Leslie A.; McMahon, Peter B.; Rosen, Michael R.

2015-01-01

About 130 million people in the United States rely on groundwater for drinking water, and the need for high-quality drinking-water supplies becomes more urgent as our population grows. Although groundwater is a safe, reliable source of drinking water for millions of people nationwide, high concentrations of some chemical constituents can pose potential human-health concerns. Some of these contaminants come from the rocks and sediments of the aquifers themselves, and others are chemicals that we use in agriculture, industry, and day-to-day life. When groundwater supplies are contaminated, millions of dollars can be required for treatment so that the supplies can be usable. Contaminants in groundwater can also affect the health of our streams and valuable coastal waters. By knowing where contaminants occur in groundwater, what factors control contaminant concentrations, and what kinds of changes in groundwater quality might be expected in the future, we can ensure the availability and quality of this vital natural resource in the future.

George M. Low Trophy: NASA's quality and excellence award

NASA Technical Reports Server (NTRS)

1991-01-01

NASA's major goal is the preservation of America's position as a leader in the aerospace industry. To maintain that status, it is crucial that the products and services we depend upon from NASA contractors, subcontractors, and suppliers meet the highest quality standards to ensure the space program's success. The George M. Low Trophy: NASA's Quality and Excellence Award is the result of NASA's desire to encourage continuous improvement and Total Quality Management (TQM) in the aerospace industry and is awarded to members of NASA's contractor community that have demonstrated sustained excellence, customer orientation, and outstanding achievements in a Total Quality Management (TQM) environment. The purpose in presenting this award is to increase public awareness of the importance of quality and productivity to the nation's aerospace industry and the nation's leadership position overall; encourage domestic business to continuously pursue efforts that enhance quality and increase productivity which will strengthen the nation's competitiveness in the international arena; and provide a forum for sharing the successful techniques and strategies used by applicants with other American organizations. Awards to Rockwell International and Marotta Scientific Controls, Inc. are announced and discussed.

Data quality through a web-based QA/QC system: implementation for atmospheric mercury data from the global mercury observation system.

PubMed

D'Amore, Francesco; Bencardino, Mariantonia; Cinnirella, Sergio; Sprovieri, Francesca; Pirrone, Nicola

2015-08-01

The overall goal of the on-going Global Mercury Observation System (GMOS) project is to develop a coordinated global monitoring network for mercury, including ground-based, high altitude and sea level stations. In order to ensure data reliability and comparability, a significant effort has been made to implement a centralized system, which is designed to quality assure and quality control atmospheric mercury datasets. This system, GMOS-Data Quality Management (G-DQM), uses a web-based approach with real-time adaptive monitoring procedures aimed at preventing the production of poor-quality data. G-DQM is plugged on a cyberinfrastructure and deployed as a service. Atmospheric mercury datasets, produced during the first-three years of the GMOS project, are used as the input to demonstrate the application of the G-DQM and how it identifies a number of key issues concerning data quality. The major issues influencing data quality are presented and discussed for the GMOS stations under study. Atmospheric mercury data collected at the Longobucco (Italy) station is used as a detailed case study.

Our New Wisconsin Promise: A Quality Education for Every Child. Education, Economic Development, and Global Competitiveness in the 21st Century. Bulletin No. 07025

ERIC Educational Resources Information Center

Wisconsin Department of Public Instruction, 2006

2006-01-01

This bulletin outlines the New Wisconsin Promise program - a commitment to ensuring that every Wisconsin child graduates with the knowledge and skills necessary for success in the twenty-first century global society by: (1) Ensuring quality teachers in every classroom and strong leadership in every school; (2) Improving student achievement with a…

[Role of medium-sized independent laboratories in control of healthcare-associated infection].

PubMed

Anzai, Eiko; Fukui, Toru

2009-05-01

In 2006, the Ministry of Health and Welfare revised the regulations regarding the Medical Service Law. The amendments stipulate that all healthcare institutions are required to implement infection control programs. However, small hospitals and clinics have no clinical microbiology laboratories, whereas medium-sized hospitals have few medical technologists and the outsourcing of microbiology tests to independent laboratories is common. The decreasing number of laboratories and recent outsourcing tendency reflect the increasing commercialization, and, with it, the escalating number of commercially operating chains. Each independent laboratory is responsible for supporting activities related to the surveillance, control, and prevention of healthcare-associated infections in the associated small and medium-sized hospitals. The people responsible for infection control in these hospitals usually do not have a background in microbiology. The evaluation of communication between independent laboratory staff and hospital personnel, and rapid turnaround time of microbiology laboratory test reports are important elements ensuring the quality of independent laboratory work. With the pressures of financial constraints in the Japanese medical insurance system, the development of a cost-effective and practical protocol for quality assurance is a real dilemma.

Using a Ventilation Controller to Optimize Residential Passive Ventilation For Energy and Indoor Air Quality

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

Turner, William; Walker, Iain

One way to reduce the energy impact of providing residential ventilation is to use passive and hybrid systems. However, these passive and hybrid (sometimes called mixed-mode) systems must still meet chronic and acute health standards for ventilation. This study uses a computer simulation approach to examine the energy and indoor air quality (IAQ) implications of passive and hybrid ventilation systems, in 16 California climate zones. Both uncontrolled and flow controlled passive stacks are assessed. A new hybrid ventilation system is outlined that uses an intelligent ventilation controller to minimise energy use, while ensuring chronic and acute IAQ standards are met.more » ASHRAE Standard 62.2-2010 – the United States standard for residential ventilation - is used as the chronic standard, and exposure limits for PM 2.5, formaldehyde and NO 2 are used as the acute standards.The results show that controlled passive ventilation and hybrid ventilation can be used in homes to provide equivalent IAQ to continuous mechanical ventilation, for less use of energy.« less

ISO 9000 and/or Systems Engineering Capability Maturity Model?

NASA Technical Reports Server (NTRS)

Gholston, Sampson E.

2002-01-01

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

WE-G-BRF-09: Force- and Image-Adaptive Strategies for Robotised Placement of 4D Ultrasound Probes

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

Kuhlemann, I; Graduate School for Computing in Life Science, University of Luebeck, Luebeck; Bruder, R

2014-06-15

Purpose: To allow continuous acquisition of high quality 4D ultrasound images for non-invasive live tracking of tumours for IGRT, image- and force-adaptive strategies for robotised placement of 4D ultrasound probes are developed and evaluated. Methods: The developed robotised ultrasound system is based on a 6-axes industrial robot (adept Viper s850) carrying a 4D ultrasound transducer with a mounted force-torque sensor. The force-adaptive placement strategies include probe position control using artificial potential fields and contact pressure regulation by a PD controller strategy. The basis for live target tracking is a continuous minimum contact pressure to ensure good image quality and highmore » patient comfort. This contact pressure can be significantly disturbed by respiratory movements and has to be compensated. All measurements were performed on human subjects under realistic conditions. When performing cardiac ultrasound, rib- and lung shadows are a common source of interference and can disrupt the tracking. To ensure continuous tracking, these artefacts had to be detected to automatically realign the probe. The detection is realised by multiple algorithms based on entropy calculations as well as a determination of the image quality. Results: Through active contact pressure regulation it was possible to reduce the variance of the contact pressure by 89.79% despite respiratory motion of the chest. The results regarding the image processing clearly demonstrate the feasibility to detect image artefacts like rib shadows in real-time. Conclusion: In all cases, it was possible to stabilise the image quality by active contact pressure control and automatically detected image artefacts. This fact enables the possibility to compensate for such interferences by realigning the probe and thus continuously optimising the ultrasound images. This is a huge step towards fully automated transducer positioning and opens the possibility for stable target tracking in ultrasoundguided radiation therapy requiring contact pressure of 5–10 N. This work was supported by the Graduate School for Computing in Medicine and Life Sciences funded by Germany's Excellence Initiative [DFG GSC 235/1].« less

The Quality and Validation of Structures from Structural Genomics

PubMed Central

Domagalski, Marcin J.; Zheng, Heping; Zimmerman, Matthew D.; Dauter, Zbigniew; Wlodawer, Alexander; Minor, Wladek

2014-01-01

Quality control of three-dimensional structures of macromolecules is a critical step to ensure the integrity of structural biology data, especially those produced by structural genomics centers. Whereas the Protein Data Bank (PDB) has proven to be a remarkable success overall, the inconsistent quality of structures reveals a lack of universal standards for structure/deposit validation. Here, we review the state-of-the-art methods used in macromolecular structure validation, focusing on validation of structures determined by X-ray crystallography. We describe some general protocols used in the rebuilding and re-refinement of problematic structural models. We also briefly discuss some frontier areas of structure validation, including refinement of protein–ligand complexes, automation of structure redetermination, and the use of NMR structures and computational models to solve X-ray crystal structures by molecular replacement. PMID:24203341

Additive Manufacturing: Ensuring Quality for Spacecraft Applications

NASA Technical Reports Server (NTRS)

Swanson, Theodore; Stephenson, Timothy

2014-01-01

Reliable manufacturing requires that material properties and fabrication processes be well defined in order to insure that the manufactured parts meet specified requirements. While this issue is now relatively straightforward for traditional processes such as subtractive manufacturing and injection molding, this capability is still evolving for AM products. Hence, one of the principal challenges within AM is in qualifying and verifying source material properties and process control. This issue is particularly critical for applications in harsh environments and demanding applications, such as spacecraft.

EHR standards--A comparative study.

PubMed

Blobel, Bernd; Pharow, Peter

2006-01-01

For ensuring quality and efficiency of patient's care, the care paradigm moves from organization-centered over process-controlled towards personal care. Such health system paradigm change leads to new paradigms for analyzing, designing, implementing and deploying supporting health information systems including EHR systems as core application in a distributed eHealth environment. The paper defines the architectural paradigm for future-proof EHR systems. It compares advanced EHR architectures referencing them at the Generic Component Model. The paper introduces the evolving paradigm of autonomous computing for self-organizing health information systems.

Conversion of Low Quality Waste Heat to Electric Power with Small-Scale Organic Rankine Cycle (ORC) Engine/Generator Technology

DTIC Science & Technology

2016-06-01

Allan Robichaux, DPW PWD GTMO and the management and staff of the GTMO on site contractor , Centerra. Page Intentionally Left Blank ii Table of...operations and maintenance contractor to ensure that data transfers are completed as required. Figure 4 shows the location of the ORC installation on MUSE...this issue with telephone support from CRM’s controls contractor (Winn-Marion, W-M); however, the problem remained unresolved as of Sept. 1 when

Food and Drug Administration regulation and evaluation of vaccines.

PubMed

Marshall, Valerie; Baylor, Norman W

2011-05-01

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management.

PubMed

Gottrup, F; Apelqvist, J; Price, P

2010-06-01

While there is a consensus that clinical practice should be evidence based, this can be difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit was to produce recommendations on clinical data collection in wound care. This document, produced by the group and disseminated by JWC, identifies criteria for producing rigorous outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent and reproducible.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick S; Ravani, Pietro

2015-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick; Ravani, Pietro

2009-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires the definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, ensure adequate samples, measure input and output variables appropriately, consider external and internal validities, limit bias, and address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

How much image noise can be added in cardiac x-ray imaging without loss in perceived image quality?

NASA Astrophysics Data System (ADS)

Gislason-Lee, Amber J.; Kumcu, Asli; Kengyelics, Stephen M.; Rhodes, Laura A.; Davies, Andrew G.

2015-03-01

Dynamic X-ray imaging systems are used for interventional cardiac procedures to treat coronary heart disease. X-ray settings are controlled automatically by specially-designed X-ray dose control mechanisms whose role is to ensure an adequate level of image quality is maintained with an acceptable radiation dose to the patient. Current commonplace dose control designs quantify image quality by performing a simple technical measurement directly from the image. However, the utility of cardiac X-ray images is in their interpretation by a cardiologist during an interventional procedure, rather than in a technical measurement. With the long term goal of devising a clinically-relevant image quality metric for an intelligent dose control system, we aim to investigate the relationship of image noise with clinical professionals' perception of dynamic image sequences. Computer-generated noise was added, in incremental amounts, to angiograms of five different patients selected to represent the range of adult cardiac patient sizes. A two alternative forced choice staircase experiment was used to determine the amount of noise which can be added to a patient image sequences without changing image quality as perceived by clinical professionals. Twenty-five viewing sessions (five for each patient) were completed by thirteen observers. Results demonstrated scope to increase the noise of cardiac X-ray images by up to 21% +/- 8% before it is noticeable by clinical professionals. This indicates a potential for 21% radiation dose reduction since X-ray image noise and radiation dose are directly related; this would be beneficial to both patients and personnel.

Applicability of refractometry for fast routine checking of hospital preparations.

PubMed

Hendrickx, Stijn; Verón, Aurora Monteagudo; Van Schepdael, Ann; Adams, Erwin

2016-04-30

Quality control of hospital pharmacy formulations is of the utmost importance to ensure constant quality and to avoid potential mistakes before administration to the patient. In this study we investigated the applicability of refractometry as a fast, inexpensive and easy-to-use quality control measurement. Refractive indices (RI) of a multitude of different hospital formulations with varying concentrations of active compound were measured. The samples consisted of a number of binary aqueous solutions (one compound in water), complex aqueous solutions (multiple compounds in water or in a constant matrix), two suspensions and one emulsion. For all these formulations, linear regression analysis was performed, quality control limits determined and accuracy and repeatability were checked. Subsequently, actual hospital pharmacy samples were analyzed to check whether they were within the specified limits. For both binary and complex aqueous formulations, repeatability was good and a linear correlation for all samples could be observed on condition that the concentration of the active compound was sufficiently high. The refractometer was not sensitive enough for solutions of folic acid and levothyroxine, which had too low a concentration of active compound. Due to lack of homogeneity and light scattering, emulsions and suspensions do not seem suitable for quality control by refractometry. A mathematical equation was generated to predict the refractive index of an aqueous solution containing clonidine HCl as active compound. Values calculated from the equation were compared with measured values and deviations of all samples were found to be lower than 1.3%. In order to use refractometry in a hospital pharmacy for quality control of multicomponent samples, additional intermediate measurements would be required, to overcome the fact that refractometry is not compound specific. In conclusion, we found that refractometry could potentially be useful for daily, fast quality measurements of relatively concentrated binary and more complex aqueous solutions in the hospital pharmacy. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

Kroes, Burt H

2014-12-02

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

Systematic review of mental health and well-being outcomes following community-based obesity prevention interventions among adolescents

PubMed Central

Hoare, Erin; Fuller-Tyszkiewicz, Matthew; Skouteris, Helen; Millar, Lynne; Nichols, Melanie; Allender, Steven

2015-01-01

Objectives This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations. Setting Systematic review of literature from database inception to October 2014. Articles were sourced from CINAHL, Global Health, Health Source: Nursing and Academic Edition, MEDLINE, PsycARTICLES and PsycINFO, all of which were accessed through EBSCOhost. The Cochrane Database was also searched to identify all eligible articles. PRISMA guidelines were followed and search terms and search strategy ensured all possible studies were identified for review. Participants Intervention studies were eligible for inclusion if they were: focused on overweight or obesity prevention, community-based, targeted adolescents (aged 10–19 years), reported a mental health or well-being measure, and included a comparison or control group. Studies that focused on specific adolescent groups or were treatment interventions were excluded from review. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Primary and secondary outcome measures Primary outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures. Results Seven studies met the inclusion criteria; one reported anxiety/depressive outcomes, two reported on self-perception well-being measures such as self-esteem and self-efficacy, and four studies reported outcomes of quality of life. Positive mental health outcomes demonstrated that following obesity prevention, interventions included a decrease in anxiety and improved health-related quality of life. Quality of evidence was graded as very low. Conclusions Although positive outcomes for mental health and well-being do exist, controlled evaluations of community-based obesity prevention interventions have not often included mental health measures (n=7). It is recommended that future interventions incorporate mental health and well-being measures to identify any potential mechanisms influencing adolescent weight-related outcomes, and equally to ensure interventions are not causing harm to adolescent mental health. PMID:25564145

[Packaging: the guarantee of medicinal quality].

PubMed

Chaumeil, J-C

2003-01-01

Primary packaging guarantees the pharmaceutical quality of the medicinal preparation received by the patient. Glass bottles containing parenteral solutions for example ensure that sterility, quality and optimal stability are preserved until administration. Recent innovations in materials research has lead to improvements in parenteral infusions. Multicompartmental bags, allowing extemporaneous mixtures without opening the container, constitute an extremely beneficial advance for the patient, allowing administration of mixtures with solutions and emulsions which would be unstable if stored. Metered dose pressurized inhalers are an excellent example of drug administration devices designed specifically to ensure quality and bioavailability. These examples illustrate the important role of primary packaging and demonstrate the usefulness of research and development in this area.

Ensuring Quality Cancer Care: A Follow-Up Review of the Institute of Medicine’s Ten Recommendations for Improving the Quality of Cancer Care in America

PubMed Central

Spinks, Tracy; Albright, Heidi W.; Feeley, Thomas W.; Walters, Ron; Burke, Thomas W.; Aloia, Thomas; Bruera, Eduardo; Buzdar, Aman; Foxhall, Lewis; Hui, David; Summers, Barbara; Rodriguez, Alma; DuBois, Raymond; Shine, Kenneth I.

2011-01-01

Responding to growing concerns regarding the safety, quality, and efficacy of cancer care in the United States, the Institute of Medicine (IOM) of the National Academy of Sciences commissioned a comprehensive review of cancer care delivery in the US healthcare system in the late 1990s. The National Cancer Policy Board (NCPB), a twenty-member board with broad representation, performed this review. In its review, the NCPB focused on the state of cancer care delivery at that time, its shortcomings, and ways to measure and improve the quality of cancer care. The NCPB described an ideal cancer care system, where patients would have equitable access to coordinated, guideline-based care and novel therapies throughout the course of their disease. In 1999, the IOM published the results of this review in its influential report, Ensuring Quality Cancer Care. This report outlined ten recommendations, which, when implemented, would: 1) improve the quality of cancer care; 2) increase our understanding of quality cancer care; and, 3) reduce or eliminate access barriers to quality cancer care. Despite the fervor generated by this report, there are lingering doubts regarding the safety and quality of cancer care in the United States today. Increased awareness of medical errors and barriers to quality care, coupled with escalating healthcare costs, has prompted national efforts to reform the healthcare system. These efforts by healthcare providers and policymakers should bridge the gap between the ideal state described in Ensuring Quality Cancer Care and the current state of cancer care in the United States. PMID:22045610

Drug quality in South Africa: perceptions of key players involved in medicines distribution.

PubMed

Patel, Aarti; Norris, Pauline; Gauld, Robin; Rades, Thomas

2009-01-01

Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process. The approach taken was qualitative data collection through key informant interviews using a semi-structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted. Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research. The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).

76 FR 8753 - Final Information Quality Guidelines Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

... DEPARTMENT OF HOMELAND SECURITY Final Information Quality Guidelines Policy AGENCY: Department of Homeland Security. ACTION: Notice and request for public comment on Final Information Quality Guidelines. SUMMARY: These guidelines should be used to ensure and maximize the quality of disseminated information...

75 FR 37819 - Proposed Information Quality Guidelines Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... DEPARTMENT OF HOMELAND SECURITY Proposed Information Quality Guidelines Policy ACTION: Notice and request for public comment on Proposed Information Quality Guidelines. SUMMARY: These guidelines should be used to ensure and maximize the quality of disseminated information. The Department's guidelines are...

Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.

PubMed

Stacey, Glyn N; Coecke, Sandra; Price, Anna-Bal; Healy, Lyn; Jennings, Paul; Wilmes, Anja; Pinset, Christian; Ingelman-Sundberg, Magnus; Louisse, Jochem; Haupt, Simone; Kidd, Darren; Robitski, Andrea; Jahnke, Heinz-Georg; Lemaitre, Gilles; Myatt, Glenn

Quality control of cell cultures used in new in vitro toxicology assays is crucial to the provision of reliable, reproducible and accurate toxicity data on new drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to be acceptable for regulatory, laboratory safety and commercial purposes. Also addressed is the development of hPSC-based assays for the tissue and cell types of greatest interest in drug toxicology. The chapter draws on a range of expert opinion within the European Commission/Cosmetics Europe-funded alternative testing cluster SEURAT-1 and consensus from international groups delivering this guidance such as the International Stem Cell Banking Initiative. Accordingly, the chapter summarizes the most up-date best practices in the use and quality control of human Pluripotent Stem Cell lines in the development of in vitro toxicity assays from leading experts in the field.

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

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

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

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

Sound data management as a foundation for natural resources management and science

USGS Publications Warehouse

Burley, Thomas E.

2012-01-01

Effective decision making is closely related to the quality and completeness of available data and information. Data management helps to ensure data quality in any discipline and supports decision making. Managing data as a long-term scientific asset helps to ensure that data will be usable beyond the original intended application. Emerging issues in water-resources management and climate variability require the ability to analyze change in the conditions of natural resources over time. The availability of quality, well-managed, and documented data from the past and present helps support this requirement.

The implementation of a Hazard Analysis and Critical Control Point management system in a peanut butter ice cream plant.

PubMed

Hung, Yu-Ting; Liu, Chi-Te; Peng, I-Chen; Hsu, Chin; Yu, Roch-Chui; Cheng, Kuan-Chen

2015-09-01

To ensure the safety of the peanut butter ice cream manufacture, a Hazard Analysis and Critical Control Point (HACCP) plan has been designed and applied to the production process. Potential biological, chemical, and physical hazards in each manufacturing procedure were identified. Critical control points for the peanut butter ice cream were then determined as the pasteurization and freezing process. The establishment of a monitoring system, corrective actions, verification procedures, and documentation and record keeping were followed to complete the HACCP program. The results of this study indicate that implementing the HACCP system in food industries can effectively enhance food safety and quality while improving the production management. Copyright © 2015. Published by Elsevier B.V.

From Board to Bedside: How the Application of Financial Structures to Safety and Quality Can Drive Accountability in a Large Health Care System.

PubMed

Austin, J Matthew; Demski, Renee; Callender, Tiffany; Lee, K H Ken; Hoffman, Ann; Allen, Lisa; Radke, Deborah A; Kim, Yungjin; Werthman, Ronald J; Peterson, Ronald R; Pronovost, Peter J

2017-04-01

As the health care system in the United States places greater emphasis on the public reporting of quality and safety data and its use to determine payment, provider organizations must implement structures that ensure discipline and rigor regarding these data. An academic health system, as part of a performance management system, applied four key components of a financial reporting structure to support the goal of top-to-bottom accountability for improving quality and safety. The four components implemented by Johns Hopkins Medicine were governance, accountability, reporting of consolidated quality performance statements, and auditing. Governance is provided by the health system's Patient Safety and Quality Board Committee, which reviews goals and strategy for patient safety and quality, reviews quarterly performance for each entity, and holds organizational leaders accountable for performance. An accountability plan includes escalating levels of review corresponding to the number of months an entity misses the defined performance target for a measure. A consolidated quality statement helps inform the Patient Safety and Quality Board Committee and leadership on key quality and safety issues. An audit evaluates the efficiency and effectiveness of processes for data collection, validation, and storage, as to ensure the accuracy and completeness of quality measure reporting. If hospitals and health systems truly want to prioritize improvements in safety and quality, they will need to create a performance management system that ensures data validity and supports performance accountability. Without valid data, it is difficult to know whether a performance gap is due to data quality or clinical quality. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

Roles of laboratories and laboratory systems in effective tuberculosis programmes.

PubMed

Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul

2007-05-01

Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.

A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins.

PubMed

Xu, Weichen; Jimenez, Rod Brian; Mowery, Rachel; Luo, Haibin; Cao, Mingyan; Agarwal, Nitin; Ramos, Irina; Wang, Xiangyang; Wang, Jihong

2017-10-01

During manufacturing and storage process, therapeutic proteins are subject to various post-translational modifications (PTMs), such as isomerization, deamidation, oxidation, disulfide bond modifications and glycosylation. Certain PTMs may affect bioactivity, stability or pharmacokinetics and pharmacodynamics profile and are therefore classified as potential critical quality attributes (pCQAs). Identifying, monitoring and controlling these PTMs are usually key elements of the Quality by Design (QbD) approach. Traditionally, multiple analytical methods are utilized for these purposes, which is time consuming and costly. In recent years, multi-attribute monitoring methods have been developed in the biopharmaceutical industry. However, these methods combine high-end mass spectrometry with complicated data analysis software, which could pose difficulty when implementing in a quality control (QC) environment. Here we report a multi-attribute method (MAM) using a Quadrupole Dalton (QDa) mass detector to selectively monitor and quantitate PTMs in a therapeutic monoclonal antibody. The result output from the QDa-based MAM is straightforward and automatic. Evaluation results indicate this method provides comparable results to the traditional assays. To ensure future application in the QC environment, this method was qualified according to the International Conference on Harmonization (ICH) guideline and applied in the characterization of drug substance and stability samples. The QDa-based MAM is shown to be an extremely useful tool for product and process characterization studies that facilitates facile understanding of process impact on multiple quality attributes, while being QC friendly and cost-effective.

Quality of life, coach behaviour and competitive anxiety in Winter Youth Olympic Games participants.

PubMed

Ledochowski, Larissa; Unterrainer, Christine; Ruedl, Gerhard; Schnitzer, Martin; Kopp, Martin

2012-12-01

To ensure the highest technical performance, speed, safety, excellent control and to improve competitive performance, a successful regulation of competitive anxiety is necessary. Therefore, it seems crucial to identify factors influencing competitive anxiety of adolescent athletes. Research suggests that people reporting high quality of life are more capable to cope with stressful and challenging situations than others. The aim of this study was to investigate the impact of quality of life, the involvement of parents in sports career and coach's leadership behaviour on competitive anxiety in Winter Youth Olympic Games participants. During the first Winter Youth Olympic Games 2012 in Innsbruck/Austria, 662 (316 women) participants completed questionnaires and single items to assess quality of life, coach's leadership behaviour, parental involvement in sports career and competitive anxiety. Multiple regression analysis revealed positive influences of high quality of life and useful coach instruction on competitive anxiety. The relationship between quality of life, coach behaviour and competitive anxiety in young elite athletes competing at the first Winter Youth Olympic Games should be considered in long-term programmes for reducing competitive stress.

Food and Drug Administration: Helping pharmacists ensure that patients receive high-quality medicines.

PubMed

Kremzner, Mary

2016-01-01

Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems. Published by Elsevier Inc.

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

PubMed

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

[Identification and analysis of Corydalis boweri, Meconopsis horridula and their close related species of the same genus by using ITS2 DNA barcode].

PubMed

Dou, Rong-kun; Bi, Zhen-fei; Bai, Rui-xue; Ren, Yao-yao; Tan, Rui; Song, Liang-ke; Li, Di-qiang; Mao, Can-quan

2015-04-01

The study is aimed to ensure the quality and safety of medicinal plants by using ITS2 DNA barcode technology to identify Corydalis boweri, Meconopsis horridula and their close related species. The DNA of 13 herb samples including C. boweri and M. horridula from Lhasa of Tibet was extracted, ITS PCR were amplified and sequenced. Both assembled and web downloaded 71 ITS2 sequences were removed of 5. 8S and 28S. Multiple sequence alignment was completed and the intraspecific and interspecific genetic distances were calculated by MEGA 5.0, while the neighbor-joining phylogenetic trees were constructed. We also predicted the ITS2 secondary structure of C. boweri, M. horridula and their close related species. The results showed that ITS2 as DNA barcode was able to identify C. boweri, M. horridula as well as well as their close related species effectively. The established based on ITS2 barcode method provides the regular and safe detection technology for identification of C. boweri, M. horridula and their close related species, adulterants and counterfeits, in order to ensure their quality control, safe medication, reasonable development and utilization.

Adoption of Stream Fencing Among Dairy Farmers in Four New Zealand Catchments

NASA Astrophysics Data System (ADS)

Bewsell, Denise; Monaghan, Ross M.; Kaine, Geoff

2007-08-01

The effect of dairy farming on water quality in New Zealand streams has been identified as an important environmental issue. Stream fencing, to keep cattle out of streams, is seen as a way to improve water quality. Fencing ensures that cattle cannot defecate in the stream, prevents bank erosion, and protects the aquatic habitat. Stream fencing targets have been set by the dairy industry. In this paper the results of a study to identify the factors influencing dairy farmers’ decisions to adopt stream fencing are outlined. Qualitative methods were used to gather data from 30 dairy farmers in four New Zealand catchments. Results suggest that farm contextual factors influenced farmers’ decision making when considering stream fencing. Farmers were classified into four segments based on their reasons for investing in stream fencing. These reasons were fencing boundaries, fencing for stock control, fencing to protect animal health, and fencing because of pressure to conform to local government guidelines or industry codes of practice. This suggests that adoption may be slow in the absence of on-farm benefits, that promotion of stream fencing needs to be strongly linked to on-farm benefits, and that regulation could play a role in ensuring greater adoption of stream fencing.

Methods for Ensuring High Quality of Coding of Cause of Death. The Mortality Register to Follow Southern Urals Populations Exposed to Radiation.

PubMed

Startsev, N; Dimov, P; Grosche, B; Tretyakov, F; Schüz, J; Akleyev, A

2015-01-01

To follow up populations exposed to several radiation accidents in the Southern Urals, a cause-of-death registry was established at the Urals Center capturing deaths in the Chelyabinsk, Kurgan and Sverdlovsk region since 1950. When registering deaths over such a long time period, quality measures need to be in place to maintain quality and reduce the impact of individual coders as well as quality changes in death certificates. To ensure the uniformity of coding, a method for semi-automatic coding was developed, which is described here. Briefly, the method is based on a dynamic thesaurus, database-supported coding and parallel coding by two different individuals. A comparison of the proposed method for organizing the coding process with the common procedure of coding showed good agreement, with, at the end of the coding process, 70  - 90% agreement for the three-digit ICD -9 rubrics. The semi-automatic method ensures a sufficiently high quality of coding by at the same time providing an opportunity to reduce the labor intensity inherent in the creation of large-volume cause-of-death registries.

Substation Reactive Power Regulation Strategy

NASA Astrophysics Data System (ADS)

Zhang, Junfeng; Zhang, Chunwang; Ma, Daqing

2018-01-01

With the increasing requirements on the power supply quality and reliability of distribution network, voltage and reactive power regulation of substations has become one of the indispensable ways to ensure voltage quality and reactive power balance and to improve the economy and reliability of distribution network. Therefore, it is a general concern of the current power workers and operators that what kind of flexible and effective control method should be used to adjust the on-load tap-changer (OLTC) transformer and shunt compensation capacitor in a substation to achieve reactive power balance in situ, improve voltage pass rate, increase power factor and reduce active power loss. In this paper, based on the traditional nine-zone diagram and combining with the characteristics of substation, a fuzzy variable-center nine-zone diagram control method is proposed and used to make a comprehensive regulation of substation voltage and reactive power. Through the calculation and simulation of the example, this method is proved to have satisfactorily reconciled the contradiction between reactive power and voltage in real-time control and achieved the basic goal of real-time control of the substation, providing a reference value to the practical application of the substation real-time control method.

Electron beam processing of fresh produce - A critical review

NASA Astrophysics Data System (ADS)

Pillai, Suresh D.; Shayanfar, Shima

2018-02-01

To meet the increasing global demand for fresh produce, robust processing methods that ensures both the safety and quality of fresh produce are needed. Since fresh produce cannot withstand thermal processing conditions, most of common safety interventions used in other foods are ineffective. Electron beam (eBeam) is a non-thermal technology that can be used to extend the shelf life and ensure the microbiological safety of fresh produce. There have been studies documenting the application of eBeam to ensure both safety and quality in fresh produce, however, there are still unexplored areas that still need further research. This is a critical review on the current literature on the application of eBeam technology for fresh produce.

Water Wells Monitoring Using SCADA System for Water Supply Network, Case Study: Water Treatment Plant Urseni, Timis County, Romania

NASA Astrophysics Data System (ADS)

Adrian-Lucian, Cococeanu; Ioana-Alina, Cretan; Ivona, Cojocinescu Mihaela; Teodor Eugen, Man; Narcis, Pelea George

2017-10-01

The water supply system in Timisoara Municipality is insured with about 25-30 % of the water demand from wells. The underground water headed to the water treatment plant in order to ensure equal distribution and pressure to consumers. The treatment plants used are Urseni and Ronaţ, near Timisoara, in Timis County. In Timisoara groundwater represents an alternative source for water supply and complementary to the surface water source. The present paper presents a case study with proposal and solutions for rehabilitation /equipment /modernization/ automation of water drilling in order to ensure that the entire system can be monitored and controlled remotely through SCADA (Supervisory control and data acquisition) system. The data collected from the field are designed for online efficiency monitoring regarding the energy consumption and water flow intake, performance indicators such as specific energy consumption KW/m3 and also in order to create a hydraulically system of the operating area to track the behavior of aquifers in time regarding the quality and quantity aspects.

Water pollution control technology and strategy for river-lake systems: a case study in Gehu Lake and Taige Canal.

PubMed

Zhang, Yimin; Zhang, Yongchun; Gao, Yuexiang; Zhang, Houhu; Cao, Jianying; Cai, Jinbang; Kong, Xiangji

2011-07-01

The Taoge water system is located in the upstream of Taihu Lake basin and is characterized by its multi-connected rivers and lakes. In this paper, current analyses of hydrology, hydrodynamics and water pollution of Gehu Lake and Taige Canal are presented. Several technologies are proposed for pollution prevention and control, and water environmental protection in the Taihu Lake basin. These included water pollution control integration technology for the water systems of Gehu Lake, Taige Canal and Caoqiao River. Additionally, river-lake water quality and quantity regulation technology, ecological restoration technology for polluted and degraded water bodies, and water environmental integration management and optimization strategies were also examined. The main objectives of these strategies are to: (a) improve environmental quality of relative water bodies, prevent pollutants from entering Gehu Lake and Taige Canal, and ensure that the clean water after the pre-treatment through Gehu Lake is not polluted before entering the Taihu Lake through Taige Canal; (b) stably and efficiently intercept and decrease the pollution load entering the lake through enhancing the river outlet ecological system structure function and water self-purifying capacity, and (c) designate Gehu Lake as a regulation system for water quality and water quantity in the Taoge water system and thus guarantee the improvement of the water quality of the inflow into Taihu Lake.

Quality Assurance in Higher Education: A Review of Literature

ERIC Educational Resources Information Center

Ryan, Tricia

2015-01-01

This paper examines the literature surrounding quality assurance in global higher education. It provides an overview of accreditation as a mechanism to ensure quality in higher education, examines models of QA, and explores the concept of quality (including definitions of quality and quality assurance). In addition, this paper provides a review of…

Validation of QuEChERS analytical technique for organochlorines and synthetic pyrethroids in fruits and vegetables using GC-ECD.

PubMed

Dubey, J K; Patyal, S K; Sharma, Ajay

2018-03-19

In the present day scenario of increasing awareness and concern about the pesticides, it is very important to ensure the quality of data being generated in pesticide residue analysis. To impart confidence in the products, terms like quality assurance and quality control are used as an integral part of quality management. In order to ensure better quality of results in pesticide residue analysis, validation of analytical methods to be used is extremely important. Keeping in view the importance of validation of method, the validation of QuEChERS (quick, easy, cheap, effective, rugged, and safe) a multiresidue method for extraction of 13 organochlorines and seven synthetic pyrethroids in fruits and vegetables followed by GC ECD for quantification was done so as to use this method for analysis of samples received in the laboratory. The method has been validated as per the Guidelines issued by SANCO (French words Sante for Health and Consommateurs for Consumers) in accordance with their document SANCO/XXXX/2013. Various parameters analyzed, viz., linearity, specificity, repeatability, reproducibility, and ruggedness were found to have acceptable values with a per cent RSD of less than 10%. Limit of quantification (LOQ) for the organochlorines was established to be 0.01 and 0.05 mg kg -1 for the synthetic pyrethroids. The uncertainty of the measurement (MU) for all these compounds ranged between 1 and 10%. The matrix-match calibration was used to compensate the matrix effect on the quantification of the compounds. The overall recovery of the method ranged between 80 and 120%. These results demonstrate the applicability and acceptability of this method in routine estimation of pesticide residues of these 20 pesticides in the fruits and vegetables by the laboratory.

Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study - PEDA Study.

PubMed

Sapsirisavat, Vorapot; Vongsutilers, Vorasit; Thammajaruk, Narukjaporn; Pussadee, Kanitta; Riyaten, Prakit; Kerr, Stephen; Avihingsanon, Anchalee; Phanuphak, Praphan; Ruxrungtham, Kiat

2016-01-01

Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia. A total of 42 batches of ARV from 15 sources were sampled from January-March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription. Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity along the HIV treatment and care cascade is available.

US EPA GEOSPATIAL QUALITY COUNCIL: ENSURING QUALITY IN GEOPSPATIAL SOLUTIONS

EPA Science Inventory

In 1999, the U.S. Environmental Protection Agency (EPA), Office of Research and Development, Environmental Sciences Division, created the EPA Geospatial Quality Council (GQC) to fill the gap between the EPA Quality Assurance (QA) and Geospatial communities. GQC participants inclu...

Quality Program Provisions for Aeronautical and Space System Contractors

NASA Technical Reports Server (NTRS)

1969-01-01

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

The Higher the Quality of Teaching the Higher the Quality of Education

ERIC Educational Resources Information Center

Sultana, Naveed; Yousuf, Muhammad Imran; Ud Din, Muhammad Naseer; Rehman, Sajid

2009-01-01

The higher education plays as leadership role in the system of education. Quality education can ensure security, welfare and prosperity of a nation. The key factors influencing the quality of higher education is the quality of faculty, curriculum standards, technological infrastructure available, research environment, accreditation regime,…

Evaluation and control of microbial and chemical contamination in dialysis water plants of Italian nephrology wards.

PubMed

Totaro, M; Casini, B; Valentini, P; Miccoli, M; Giorgi, S; Porretta, A; Privitera, G; Lopalco, P L; Baggiani, A

2017-10-01

Patients receiving haemodialysis are exposed to a large volume of dialysis fluid. The Italian Society of Nephrology (ISN) has published guidelines and microbial quality standards on dialysis water (DW) and solutions to ensure patient safety. To identify microbial and chemical hazards, and evaluate the quality of disinfection treatment in DW plants. In 2015 and 2016, water networks and DW plants (closed loop and online monitors) of nine dialysis wards of Italian hospitals, hosting 162 dialysis beds overall, were sampled on a monthly basis to determine the parameters provided by ISN guidelines. Chlorinated drinking water was desalinated by reverse osmosis and distributed to the closed loop which feeds all online monitors. Disinfection with peracetic acid was performed in all DW plants on a monthly basis. Over the 24-month study period, seven out of nine DW plants (78%) recorded negative results for all investigated parameters. Closed loop contamination with Burkholderia cepacia was detected in a DW plant from January 2015 to March 2015. Pseudomonas aeruginosa was isolated from March 2016 to May 2016 in the closed loop of another DW plant. These microbial contaminations were eradicated by shock disinfection with sodium hypochlorite and peracetic acid, followed by water flushing. These results highlight the importance of chemical and physical methods of DW disinfection. The maintenance of control measures in water plants hosted in dialysis wards ensures a microbial risk reduction for all dialysis patients. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Methods for preservation and extension of shelf life.

PubMed

Gould, G W

1996-11-01

There is potential for spoilage of all foods at some rate or other following harvest, slaughter or manufacture and spoilage may occur at any of the stages between the acquisition of raw materials and the eventual consumption of a food product. These stages include processing, packaging, distribution, retail display, transport, storage and use by the consumer. They are under varying degrees of control that aim to deliver a satisfactory shelf life, to ensure that the finally-consumed product is of high quality and to ensure that it is safe. Spoilage may be caused by a wide range of reactions including some that are essentially physical, some that are chemical, some enzymic and some microbiological. The various forms of microbiological spoilage are preventable to a large degree by a wide range of preservation techniques, most of which act by preventing or inhibiting microbial growth (e.g., chilling, freezing, drying, curing, conserving, vacuum packing, modified atmosphere packing, acidifying, fermenting and adding preservatives). A smaller number of techniques act by inactivating microorganisms (e.g., pasteurization, sterilization and irradiation). Additional techniques restrict the access of microorganisms to products (e.g., aseptic processing and packaging. A major trend is that new and emerging preservation techniques which are coming into use or are under development include more that act by inactivation (e.g., ultrahigh pressure, electroporation, manothermosonication and addition of bacteriolytic enzymes). A further trend is towards the use of procedures that deliver products that are less heavily preserved, have higher quality, are more natural, freer from additives and nutritionally healthier. Less severe preservation procedures are therefore being developed that make use of preservative factors in combinations to deliver (a) less damage to product quality (hurdle technologies); (b) new methods of heating that are better controlled and therefore deliver milder heat to products; (c) cook-chill combinations that deliver longer high quality shelf lives: (d) modified atmosphere packaging to retain quality longer; and (e) use of antimicrobial systems that are more natural. Many of the existing and emerging preservation techniques act by interfering with the homeostatic mechanisms that microorganisms have evolved in order to survive extreme environmental stresses.

TRMM Microwave Imager (TMI) Updates for Final Data Version Release

NASA Technical Reports Server (NTRS)

Kroodsma, Rachael A; Bilanow, Stephen; Ji, Yimin; McKague, Darren

2017-01-01

The Tropical Rainfall Measuring Mission (TRMM) Microwave Imager (TMI) dataset released by the Precipitation Processing System (PPS) will be updated to a final version within the next year. These updates are based on increased knowledge in recent years of radiometer calibration and sensor performance issues. In particular, the Global Precipitation Measurement (GPM) Microwave Imager (GMI) is used as a model for many of the TMI version updates. This paper discusses four aspects of the TMI data product that will be improved: spacecraft attitude, calibration and quality control, along-scan bias corrections, and sensor pointing accuracy. These updates will be incorporated into the final TMI data version, improving the quality of the data product and ensuring accurate geophysical parameters can be derived from TMI.

Safe drinking water in regional NSW, Australia.

PubMed

Byleveld, Paul M; Leask, Sandy D; Jarvis, Leslie A; Wall, Katrina J; Henderson, Wendy N; Tickell, Joshua E

2016-04-15

The New South Wales (NSW) Public Health Act 2010 requires water suppliers to implement a drinking water quality assurance program that addresses the 'Framework for management of drinking water quality' in the Australian drinking water guidelines. NSW Health has recognised the importance of a staged implementation of this requirement and the need to support regional water utilities. To date, NSW Health has assisted 74 regional utilities to develop and implement their management systems. The Public Health Act 2010 has increased awareness of drinking water risk management, and offers a systematic process to identify and control risks. This has benefited large utilities, smaller suppliers, and remote and Aboriginal communities. Work is continuing to ensure implementation of the process by private suppliers and water carters.

Influence of irrigation during the growth stage on yield and quality in mango (Mangifera indica L)

PubMed Central

Wei, Junya; Liu, Guoyin; Liu, Debing; Chen, Yeyuan

2017-01-01

Although being one of the few drought-tolerant plants, mango trees are irrigated to ensure optimum and consistent productivity in China. In order to better understand the effects of soil water content on mango yield and fruit quality at fruit growth stage, irrigation experiments were investigated and the object was to determine the soil water content criteria at which growth and quality of mango would be optimal based on soil water measured by RHD-JS water-saving irrigation system through micro-sprinkling irrigation. Five soil water content treatments (relative to the percentage of field water capacity) for irrigation (T1:79%-82%, T2:75%-78%, T3:71%-74%, T4: 65%-70%, T5:63%-66%) were compared in 2013. Amount of applied irrigation water for different treatments varied from 2.93m3 to 1.08 m3. The results showed that mango fruit production and quality at fruit growth stage were significantly affected under different irrigation water amounts. Variation in soil water content not only had effects on fruit size, but also on fruit yield. The highest fruit yield and irrigation water use efficiency were obtained from the T4 treatment. Irrigation water amount also affected fruit quality parameters like fruit total soluble solids, soluble sugar, starch, titratable acid and vitamin C content. Comprehensive evaluation of the effect of indexs of correlation on irrigation treatment by subordinate function showed that when the soil moisture content were controlled at about 65–70% of the field water moisture capacity, water demand in the growth and development of mango could be ensured, and maximum production efficiency of irrigation and the best quality of fruit could be achieved. In conclusion, treatment T4 was the optimum irrigation schedule for growing mango, thus achieving efficient production of mango in consideration of the compromise among mango yield, fruit quality and water use efficiency. PMID:28384647

Influence of irrigation during the growth stage on yield and quality in mango (Mangifera indica L).

PubMed

Wei, Junya; Liu, Guoyin; Liu, Debing; Chen, Yeyuan

2017-01-01

Although being one of the few drought-tolerant plants, mango trees are irrigated to ensure optimum and consistent productivity in China. In order to better understand the effects of soil water content on mango yield and fruit quality at fruit growth stage, irrigation experiments were investigated and the object was to determine the soil water content criteria at which growth and quality of mango would be optimal based on soil water measured by RHD-JS water-saving irrigation system through micro-sprinkling irrigation. Five soil water content treatments (relative to the percentage of field water capacity) for irrigation (T1:79%-82%, T2:75%-78%, T3:71%-74%, T4: 65%-70%, T5:63%-66%) were compared in 2013. Amount of applied irrigation water for different treatments varied from 2.93m3 to 1.08 m3. The results showed that mango fruit production and quality at fruit growth stage were significantly affected under different irrigation water amounts. Variation in soil water content not only had effects on fruit size, but also on fruit yield. The highest fruit yield and irrigation water use efficiency were obtained from the T4 treatment. Irrigation water amount also affected fruit quality parameters like fruit total soluble solids, soluble sugar, starch, titratable acid and vitamin C content. Comprehensive evaluation of the effect of indexs of correlation on irrigation treatment by subordinate function showed that when the soil moisture content were controlled at about 65-70% of the field water moisture capacity, water demand in the growth and development of mango could be ensured, and maximum production efficiency of irrigation and the best quality of fruit could be achieved. In conclusion, treatment T4 was the optimum irrigation schedule for growing mango, thus achieving efficient production of mango in consideration of the compromise among mango yield, fruit quality and water use efficiency.

Infection control in home-based care for people living with HIV/AIDS/TB in South Africa: an exploratory study.

PubMed

Akintola, Olagoke; Hangulu, Lydia

2014-01-01

The majority of HIV and AIDS patients in sub-Saharan African countries receive health care services at home. Yet research on infection control in home-based care settings is virtually non-existent. This study explored infection control practices in home-based care in a South African province with a high HIV/TB prevalence. We conducted interviews with 10 managers of home-based care organizations and 10 focus group discussions with 80 volunteer caregivers working in high HIV/TB prevalent communities in South Africa. Findings show that volunteers had insufficient training on infection control. Materials necessary for the maintenance of hygiene and protective equipment were in short supply and the protective equipment supplied was of poor quality. Home-based care patients lived in crowded and poor conditions, and family members were negatively disposed to the use of protective devices. Together, these factors put volunteers and family caregivers at risk of infection with HIV and TB. Health policy should address the training of volunteer caregivers and the regular supply of good quality materials to ensure effective infection control. It is also important to educate families on infection control. Finally, there is a need to integrate HIV and TB control at the community level.

DSSTOX MASTER STRUCTURE-INDEX FILE: SDF FILE AND ...

EPA Pesticide Factsheets

The DSSTox Master Structure-Index File serves to consolidate, manage, and ensure quality and uniformity of the chemical and substance information spanning all DSSTox Structure Data Files, including those in development but not yet published separately on this website. The DSSTox Master Structure-Index File serves to consolidate, manage, and ensure quality and uniformity of the chemical and substance information spanning all DSSTox Structure Data Files, including those in development but not yet published separately on this website.

Recommendations for cervical cancer prevention in Latin America and the Caribbean.

PubMed

Muñoz, Nubia; Franco, Eduardo L; Herrero, Rolando; Andrus, Jon Kim; de Quadros, Ciro; Goldie, Sue J; Bosch, F Xavier

2008-08-19

Cervical cancer control in the Latin America and Caribbean (LAC) region has been, and remains, a priority and a major public health challenge. It also provides the opportunity for the advancement of research into novel cervical cancer preventative tools including the use of prophylactic human papillomavirus (HPV) vaccines, HPV-based screening options and low technology visual inspection methods. The challenges for prevention are compounded because cervical cancer cases continue to cluster in the low socio-economic and rural populations, thus requiring strong political and social commitments to ensure effective implementation in the region. Although cytology-based screening activities exist in the majority of LAC countries, these have been largely based on opportunistic screening services. Evaluation of the impact of screening is often focused on assessing coverage of the population with Pap smears. However, regardless of the chosen technology a screening program requires a complex set of activities that must also be of high quality such us ensuring access of the underserved populations to the program, maintaining routine quality controls of the screening procedures and organizing the proper follow-up of women with abnormal screening results. The cost of the HPV vaccine and of the delivery infrastructure required is currently a significant obstacle for widespread introduction that will require collaborative resolve between public health organizations, governments and vaccine manufacturers. It is important to ensure that HPV vaccines are made available to the wider public, not only to those who can afford it. This monograph and the associated regional reports have carefully identified and discussed the many challenges and opportunities to be considered for policy decisions, in particular the complex interplay between vaccination strategies and subsequent screening requirements. An advanced cost-benefit analysis, using models calibrated to specific countries in the region, presents the range of options and relative costs thus providing evidence-based scientific guidance to governments and providers in the context of a significant and systematic international review effort.

Motorcycle helmets in Vietnam: ownership, quality, purchase price, and affordability.

PubMed

Hung, Dang Viet; Stevenson, Mark R; Ivers, Rebecca Q

2008-06-01

This study investigated motorcycle helmet ownership, quality, purchase price, and affordability in Vietnam. A random sample of motorcyclists was interviewed to investigate aspects of helmet ownership, the purchase price, and affordability of a motorcycle helmet. Multivariate modeling conducted to determine factors associated with the purchase price and affordability of motorcycle helmets. Helmet quality was assessed based on current legal requirements in Vietnam. The prevalence of helmet use in Vietnam remains low (23.3%) despite a high level of helmet ownership (94%), indicating that this is an important area for public health intervention. Overall the quality of helmets appeared to be good; however, few helmets displayed legally required information. Motorcyclists with a high income purchase more helmets for their household rather than more expensive helmets. To ensure that helmets are accessible to the community, policy-makers need to consider pricing motorcycle helmets at a price indicated by the results of this study. Prior to universal motorcycle helmet legislation, the government will also need to ensure that standard helmets are available and that enforcement is at a level to ensure that motorcycle helmets are actually used.

Disaster Victim Identification: quality management from an odontology perspective.

PubMed

Lake, A W; James, H; Berketa, J W

2012-06-01

The desired outcome of the victim identification component of a mass fatality event is correct identification of deceased persons in a timely manner allowing legal and social closure for relatives of the victims. Quality Management across all aspects of the Disaster Victim Identification (DVI) structure facilitates this process. Quality Management in forensic odontology is the understanding and implementation of a methodology that ensures collection, collation and preservation of the maximum amount of available dental data and the appropriate interpretation of that data to achieve outcomes to a standard expected by the DVI instructing authority, impacted parties and the forensic odontology specialist community. Managerial pre-event planning responsibility, via an odontology coordinator, includes setting a chain of command, developing and reviewing standard operating procedures (SOP), ensuring use of current scientific methodologies and staff training. During a DVI managerial responsibility includes tailoring SOP to the specific situation, ensuring member accreditation, encouraging inter-disciplinary cooperation and ensuring security of odontology data and work site. Individual responsibilities include the ability to work within a team, accept peer review, and share individual members' skill sets to achieve the best outcome. These responsibilities also include adherence to chain of command and the SOP, maintenance of currency of knowledge and recognition of professional boundaries of expertise. This article highlights issues of Quality Management pertaining particularly to forensic odontology but can also be extrapolated to all DVI actions.

Imitative modeling automatic system Control of steam pressure in the main steam collector with the influence on the main Servomotor steam turbine

NASA Astrophysics Data System (ADS)

Andriushin, A. V.; Zverkov, V. P.; Kuzishchin, V. F.; Ryzhkov, O. S.; Sabanin, V. R.

2017-11-01

The research and setting results of steam pressure in the main steam collector “Do itself” automatic control system (ACS) with high-speed feedback on steam pressure in the turbine regulating stage are presented. The ACS setup is performed on the simulation model of the controlled object developed for this purpose with load-dependent static and dynamic characteristics and a non-linear control algorithm with pulse control of the turbine main servomotor. A method for tuning nonlinear ACS with a numerical algorithm for multiparametric optimization and a procedure for separate dynamic adjustment of control devices in a two-loop ACS are proposed and implemented. It is shown that the nonlinear ACS adjusted with the proposed method with the regulators constant parameters ensures reliable and high-quality operation without the occurrence of oscillations in the transient processes the operating range of the turbine loads.

Control voltage and power fluctuations when connecting wind farms

NASA Astrophysics Data System (ADS)

Berinde, Ioan; Bǎlan, Horia; Oros Pop, Teodora Susana

2015-12-01

Voltage, frequency, active power and reactive power are very important parameters in terms of power quality. These parameters are followed when connecting any power plant, the more the connection of wind farms. Connecting wind farms to the electricity system must not cause interference outside the limits set by regulations. Modern solutions for fast and automatic voltage control and power fluctuations using electronic control systems of reactive power flows. FACTS (Flexible Alternating Current Transmision System) systems, established on the basis of power electronic circuits ensure control of electrical status quantities to achieve the necessary transfer of power to the power grid. FACTS devices can quickly control parameters and sizes of state power lines, such as impedance line voltages and phase angles of the voltages of the two ends of the line. Their use can lead to improvement in power system operation by increasing the transmission capacity of power lines, power flow control lines, improved static and transient stability reserve.

US EPA GEOSPATIAL QUALITY COUNCIL: ENSURING QUALITY GEOSPATIAL SOLUTIONS

EPA Science Inventory

This presentation will discuss the history, strategy, products, and future plans of the EPA Geospatial Quality Council (GQC). A topical review of GQC products will be presented including:

o Guidance for Geospatial Data Quality Assurance Project Plans.

o GPS - Tec...

The Not4 E3 Ligase and CCR4 Deadenylase Play Distinct Roles in Protein Quality Control

PubMed Central

Halter, David; Collart, Martine A.; Panasenko, Olesya O.

2014-01-01

Eukaryotic cells control their proteome by regulating protein production and protein clearance. Protein production is determined to a large extent by mRNA levels, whereas protein degradation depends mostly upon the proteasome. Dysfunction of the proteasome leads to the accumulation of non-functional proteins that can aggregate, be toxic for the cell, and, in extreme cases, lead to cell death. mRNA levels are controlled by their rates of synthesis and degradation. Recent evidence indicates that these rates have oppositely co-evolved to ensure appropriate mRNA levels. This opposite co-evolution has been correlated with the mutations in the Ccr4-Not complex. Consistently, the deadenylation enzymes responsible for the rate-limiting step in eukaryotic mRNA degradation, Caf1 and Ccr4, are subunits of the Ccr4-Not complex. Another subunit of this complex is a RING E3 ligase, Not4. It is essential for cellular protein solubility and has been proposed to be involved in co-translational quality control. An open question has been whether this role of Not4 resides strictly in the regulation of the deadenylation module of the Ccr4-Not complex. However, Not4 is important for proper assembly of the proteasome, and the Ccr4-Not complex may have multiple functional modules that participate in protein quality control in different ways. In this work we studied how the functions of the Caf1/Ccr4 and Not4 modules are connected. We concluded that Not4 plays a role in protein quality control independently of the Ccr4 deadenylase, and that it is involved in clearance of aberrant proteins at least in part via the proteasome. PMID:24465968

48 CFR 246.102 - Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE General 246.102 Policy. Departments and agencies shall also— (1) Develop and manage a systematic, cost-effective Government contract quality assurance program to ensure that contract performance conforms to specified requirements. Apply Government quality assurance...

Use of graph theory measures to identify errors in record linkage.

PubMed

Randall, Sean M; Boyd, James H; Ferrante, Anna M; Bauer, Jacqueline K; Semmens, James B

2014-07-01

Ensuring high linkage quality is important in many record linkage applications. Current methods for ensuring quality are manual and resource intensive. This paper seeks to determine the effectiveness of graph theory techniques in identifying record linkage errors. A range of graph theory techniques was applied to two linked datasets, with known truth sets. The ability of graph theory techniques to identify groups containing errors was compared to a widely used threshold setting technique. This methodology shows promise; however, further investigations into graph theory techniques are required. The development of more efficient and effective methods of improving linkage quality will result in higher quality datasets that can be delivered to researchers in shorter timeframes. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Composite adaptive control of belt polishing force for aero-engine blade

NASA Astrophysics Data System (ADS)

Zhsao, Pengbing; Shi, Yaoyao

2013-09-01

The existing methods for blade polishing mainly focus on robot polishing and manual grinding. Due to the difficulty in high-precision control of the polishing force, the blade surface precision is very low in robot polishing, in particular, quality of the inlet and exhaust edges can not satisfy the processing requirements. Manual grinding has low efficiency, high labor intensity and unstable processing quality, moreover, the polished surface is vulnerable to burn, and the surface precision and integrity are difficult to ensure. In order to further improve the profile accuracy and surface quality, a pneumatic flexible polishing force-exerting mechanism is designed and a dual-mode switching composite adaptive control(DSCAC) strategy is proposed, which combines Bang-Bang control and model reference adaptive control based on fuzzy neural network(MRACFNN) together. By the mode decision-making mechanism, Bang-Bang control is used to track the control command signal quickly when the actual polishing force is far away from the target value, and MRACFNN is utilized in smaller error ranges to improve the system robustness and control precision. Based on the mathematical model of the force-exerting mechanism, simulation analysis is implemented on DSCAC. Simulation results show that the output polishing force can better track the given signal. Finally, the blade polishing experiments are carried out on the designed polishing equipment. Experimental results show that DSCAC can effectively mitigate the influence of gas compressibility, valve dead-time effect, valve nonlinear flow, cylinder friction, measurement noise and other interference on the control precision of polishing force, which has high control precision, strong robustness, strong anti-interference ability and other advantages compared with MRACFNN. The proposed research achieves high-precision control of the polishing force, effectively improves the blade machining precision and surface consistency, and significantly reduces the surface roughness.

Low-temperature magnetotransport in Si/SiGe heterostructures on 300 mm Si wafers

NASA Astrophysics Data System (ADS)

Scappucci, Giordano; Yeoh, L.; Sabbagh, D.; Sammak, A.; Boter, J.; Droulers, G.; Kalhor, N.; Brousse, D.; Veldhorst, M.; Vandersypen, L. M. K.; Thomas, N.; Roberts, J.; Pillarisetty, R.; Amin, P.; George, H. C.; Singh, K. J.; Clarke, J. S.

Undoped Si/SiGe heterostructures are a promising material stack for the development of spin qubits in silicon. To deploy a qubit into high volume manufacturing in a quantum computer requires stringent control over substrate uniformity and quality. Electron mobility and valley splitting are two key electrical metrics of substrate quality relevant for qubits. Here we present low-temperature magnetotransport measurements of strained Si quantum wells with mobilities in excess of 100000 cm2/Vs fabricated on 300 mm wafers within the framework of advanced semiconductor manufacturing. These results are benchmarked against the results obtained in Si quantum wells deposited on 100 mm Si wafers in an academic research environment. To ensure rapid progress in quantum wells quality we have implemented fast feedback loops from materials growth, to heterostructure FET fabrication, and low temperature characterisation. On this topic we will present recent progress in developing a cryogenic platform for high-throughput magnetotransport measurements.

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.

PubMed

Jiang, Canping; Flansburg, Lisa; Ghose, Sanchayita; Jorjorian, Paul; Shukla, Abhinav A

2010-12-15

The concept of design space has been taking root under the quality by design paradigm as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. This paper outlines the development of a design space for a hydrophobic interaction chromatography (HIC) process step. The design space included the impact of raw material lot-to-lot variability and variations in the feed stream from cell culture. A failure modes and effects analysis was employed as the basis for the process characterization exercise. During mapping of the process design space, the multi-dimensional combination of operational variables were studied to quantify the impact on process performance in terms of yield and product quality. Variability in resin hydrophobicity was found to have a significant influence on step yield and high-molecular weight aggregate clearance through the HIC step. A robust operating window was identified for this process step that enabled a higher step yield while ensuring acceptable product quality. © 2010 Wiley Periodicals, Inc.

Investigation of Mechanism of Action of Modifying Admixtures Based on Products of Petrochemical Synthesis on Concrete Structure

NASA Astrophysics Data System (ADS)

Tukhareli, V. D.; Tukhareli, A. V.; Cherednichenko, T. F.

2017-11-01

The creation of composite materials for generating structural elements with the desired properties has always been and still remains relevant. The basis of a modern concrete technology is the creation of a high-quality artificial stone characterized by low defectiveness and structure stability. Improving the quality of concrete compositions can be achieved by using chemical admixtures from local raw materials which is a very promising task of modern materials’ science for creation of a new generation of concretes. The new generation concretes are high-tech, high-quality, multicomponent concrete mixes and compositions with admixtures that preserve the required properties in service under all operating conditions. The growing complexity of concrete caused by systemic effects that allow you to control the structure formation at all stages of the technology ensures the obtaining of composites with "directional" quality, compositions, structure and properties. The possibility to use the organic fraction of oil refining as a multifunctional hydrophobic-plasticizing admixture in the effective cement concrete is examined.

Introducing a feedback training system for guided home rehabilitation.

PubMed

Kohler, Fabian; Schmitz-Rode, Thomas; Disselhorst-Klug, Catherine

2010-01-15

As the number of people requiring orthopaedic intervention is growing, individualized physiotherapeutic rehabilitation and adequate postoperative care becomes increasingly relevant. The chances of improvement in the patients condition is directly related to the performance and consistency of the physiotherapeutic exercises.In this paper a smart, cost-effective and easy to use Feedback Training System for home rehabilitation based on standard resistive elements is introduced. This ensures high accuracy of the exercises performed and offers guidance and control to the patient by offering direct feedback about the performance of the movements.46 patients were recruited and performed standard physiotherapeutic training to evaluate the system. The results show a significant increase in the patient's ability to reproduce even simple physiotherapeutic exercises when being supported by the Feedback Training System. Thus physiotherapeutic training can be extended into the home environment whilst ensuring a high quality of training.

Virtual blood bank

PubMed Central

Wong, Kit Fai

2011-01-01

Virtual blood bank is the computer-controlled, electronically linked information management system that allows online ordering and real-time, remote delivery of blood for transfusion. It connects the site of testing to the point of care at a remote site in a real-time fashion with networked computers thus maintaining the integrity of immunohematology test results. It has taken the advantages of information and communication technologies to ensure the accuracy of patient, specimen and blood component identification and to enhance personnel traceability and system security. The built-in logics and process constraints in the design of the virtual blood bank can guide the selection of appropriate blood and minimize transfusion risk. The quality of blood inventory is ascertained and monitored, and an audit trail for critical procedures in the transfusion process is provided by the paperless system. Thus, the virtual blood bank can help ensure that the right patient receives the right amount of the right blood component at the right time. PMID:21383930

[The allergic child at school. What do we need to know?].

PubMed

Urrutia-Pereira, Marilyn; Solé, Dirceu

2016-01-01

Allergy is a multisystem disease in children that often occurs with the coexistence of diverse clinical manifestations that cause great impact on quality of life and academic performance due to sleep disorders arising from the disease or treatment, and absenteeism that children may experience. Because of the time spent in school, there is a possibility that allergic reactions may occur first in these facilities, where a lack of staff knowledge has been found regarding how to proceed in allergy crisis situations. Cooperative action among health teams, community, parents, and school authorities is essential to ensure that the school can prevent, recognize, and ensure quick access to emergency services (if needed) and treatment protocols for allergic reactions, thus allowing allergic children to be better protected in the school environment, which should be considered an extension of the home environment and an important arm in proper management to control the disease.

Statewide health information: a tool for improving hospital accountability.

PubMed

Epstein, M H; Kurtzig, B S

1994-07-01

By early 1994, 38 states had invested in data collection, analysis, and dissemination on the use, cost, effectiveness, and performance of hospitals. States use these data to control costs, encourage prudent purchasing, monitor effectiveness and outcomes of health care, guide health policy, and promote informed decision making. Experience in several states suggests that public release of hospital-specific data influences hospital performance. The value of state data organizations' databases to address issues of quality and accountability can be strengthened by ensuring the stability and growth of statewide health information systems, supporting research on information dissemination techniques, and promoting comparisons among hospitals. Information to measure provider performance must be placed in the public domain--to help ensure prudent and cost-effective health care purchasing and to give providers comparable information for improvement of care. State-level health databases are an essential component of the information infrastructure needed to support health reform.

Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

PubMed

Kevany, Sebastian; Khumalo-Sakutukwa, Gertrude; Singh, Basant; Chingono, Alfred; Morin, Stephen

2016-01-01

Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites ensures consistent and high quality delivery of all intervention components, in keeping with the goals of the study protocol, while also providing a forum for corrective feedback, additional supervision and retraining of staff. QAC ensures staff fidelity to study procedures and is critical to the successful delivery of multi-site HIV prevention interventions, as well as the delivery of services scaled up in programmatic situations.

Ensuring Support for Research and Quality Improvement (QI) Networks: Four Pillars of Sustainability-An Emerging Framework.

PubMed

Holve, Erin

2013-01-01

Multi-institutional research and quality improvement (QI) projects using electronic clinical data (ECD) hold great promise for improving quality of care and patient outcomes but typically require significant infrastructure investments both to initiate and maintain the project over its duration. Consequently, it is important for these projects to think holistically about sustainability to ensure their long-term success. Four "pillars" of sustainability are discussed based on the experiences of EDM Forum grantees and other research and QI networks. These include trust and value, governance, management, and financial and administrative support. Two "foundational considerations," adaptive capacity and policy levers, are also discussed.

Food safety and nutritional quality for the prevention of non communicable diseases: the Nutrient, hazard Analysis and Critical Control Point process (NACCP).

PubMed

Di Renzo, Laura; Colica, Carmen; Carraro, Alberto; Cenci Goga, Beniamino; Marsella, Luigi Tonino; Botta, Roberto; Colombo, Maria Laura; Gratteri, Santo; Chang, Ting Fa Margherita; Droli, Maurizio; Sarlo, Francesca; De Lorenzo, Antonino

2015-04-23

The important role of food and nutrition in public health is being increasingly recognized as crucial for its potential impact on health-related quality of life and the economy, both at the societal and individual levels. The prevalence of non-communicable diseases calls for a reformulation of our view of food. The Hazard Analysis and Critical Control Point (HACCP) system, first implemented in the EU with the Directive 43/93/CEE, later replaced by Regulation CE 178/2002 and Regulation CE 852/2004, is the internationally agreed approach for food safety control. Our aim is to develop a new procedure for the assessment of the Nutrient, hazard Analysis and Critical Control Point (NACCP) process, for total quality management (TMQ), and optimize nutritional levels. NACCP was based on four general principles: i) guarantee of health maintenance; ii) evaluate and assure the nutritional quality of food and TMQ; iii) give correct information to the consumers; iv) ensure an ethical profit. There are three stages for the application of the NACCP process: 1) application of NACCP for quality principles; 2) application of NACCP for health principals; 3) implementation of the NACCP process. The actions are: 1) identification of nutritional markers, which must remain intact throughout the food supply chain; 2) identification of critical control points which must monitored in order to minimize the likelihood of a reduction in quality; 3) establishment of critical limits to maintain adequate levels of nutrient; 4) establishment, and implementation of effective monitoring procedures of critical control points; 5) establishment of corrective actions; 6) identification of metabolic biomarkers; 7) evaluation of the effects of food intake, through the application of specific clinical trials; 8) establishment of procedures for consumer information; 9) implementation of the Health claim Regulation EU 1924/2006; 10) starting a training program. We calculate the risk assessment as follows: Risk (R) = probability (P) × damage (D). The NACCP process considers the entire food supply chain "from farm to consumer"; in each point of the chain it is necessary implement a tight monitoring in order to guarantee optimal nutritional quality.

40 CFR 131.10 - Designation of uses.

Code of Federal Regulations, 2012 CFR

2012-07-01

... QUALITY STANDARDS Establishment of Water Quality Standards § 131.10 Designation of uses. (a) Each State... and the appropriate criteria for those uses, the State shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment...

40 CFR 131.10 - Designation of uses.

Code of Federal Regulations, 2013 CFR

2013-07-01

... QUALITY STANDARDS Establishment of Water Quality Standards § 131.10 Designation of uses. (a) Each State... and the appropriate criteria for those uses, the State shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment...

Effective Marketing of Quality Child Care.

ERIC Educational Resources Information Center

Caldwell, Bettye M.; Boyd, Harper W., Jr.

1984-01-01

Identifies negative public and professional attitudes that lie beneath the contemporary negative image of quality child care. Argues that concepts and principles of marketing are appropriate for influencing parents to choose high quality services and helping ensure that supplementary care is of sufficient quality to enhance, not inhibit, the…

Analytical performance evaluation of a high-volume hematology laboratory utilizing sigma metrics as standard of excellence.

PubMed

Shaikh, M S; Moiz, B

2016-04-01

Around two-thirds of important clinical decisions about the management of patients are based on laboratory test results. Clinical laboratories are required to adopt quality control (QC) measures to ensure provision of accurate and precise results. Six sigma is a statistical tool, which provides opportunity to assess performance at the highest level of excellence. The purpose of this study was to assess performance of our hematological parameters on sigma scale in order to identify gaps and hence areas of improvement in patient care. Twelve analytes included in the study were hemoglobin (Hb), hematocrit (Hct), red blood cell count (RBC), mean corpuscular volume (MCV), red cell distribution width (RDW), total leukocyte count (TLC) with percentages of neutrophils (Neutr%) and lymphocytes (Lymph %), platelet count (Plt), mean platelet volume (MPV), prothrombin time (PT), and fibrinogen (Fbg). Internal quality control data and external quality assurance survey results were utilized for the calculation of sigma metrics for each analyte. Acceptable sigma value of ≥3 was obtained for the majority of the analytes included in the analysis. MCV, Plt, and Fbg achieved value of <3 for level 1 (low abnormal) control. PT performed poorly on both level 1 and 2 controls with sigma value of <3. Despite acceptable conventional QC tools, application of sigma metrics can identify analytical deficits and hence prospects for the improvement in clinical laboratories. © 2016 John Wiley & Sons Ltd.

High-throughput biomonitoring of dioxins and polychlorinated biphenyls at the sub-picogram level in human serum.

PubMed

Focant, Jean-François; Eppe, Gauthier; Massart, Anne-Cécile; Scholl, Georges; Pirard, Catherine; De Pauw, Edwin

2006-10-13

We report on the use of a state-of-the-art method for the measurement of selected polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and polychlorinated biphenyls in human serum specimens. The sample preparation procedure is based on manual small size solid-phase extraction (SPE) followed by automated clean-up and fractionation using multi-sorbent liquid chromatography columns. SPE cartridges and all clean-up columns are disposable. Samples are processed in batches of 20 units, including one blank control (BC) sample and one quality control (QC) sample. The analytical measurement is performed using gas chromatography coupled to isotope dilution high-resolution mass spectrometry. The sample throughput corresponds to one series of 20 samples per day, from sample reception to data quality cross-check and reporting, once the procedure has been started and series of samples keep being produced. Four analysts are required to ensure proper performances of the procedure. The entire procedure has been validated under International Organization for Standardization (ISO) 17025 criteria and further tested over more than 1500 unknown samples during various epidemiological studies. The method is further discussed in terms of reproducibility, efficiency and long-term stability regarding the 35 target analytes. Data related to quality control and limit of quantification (LOQ) calculations are also presented and discussed.

PIGN prevents protein aggregation in the endoplasmic reticulum independently of its function in the GPI synthesis.

PubMed

Ihara, Shinji; Nakayama, Sohei; Murakami, Yoshiko; Suzuki, Emiko; Asakawa, Masayo; Kinoshita, Taroh; Sawa, Hitoshi

2017-02-01

Quality control of proteins in the endoplasmic reticulum (ER) is essential for ensuring the integrity of secretory proteins before their release into the extracellular space. Secretory proteins that fail to pass quality control form aggregates. Here we show the PIGN-1/PIGN is required for quality control in Caenorhabditis elegans and in mammalian cells. In C. elegans pign-1 mutants, several proteins fail to be secreted and instead form abnormal aggregation. PIGN-knockout HEK293 cells also showed similar protein aggregation. Although PIGN-1/PIGN is responsible for glycosylphosphatidylinositol (GPI)-anchor biosynthesis in the ER, certain mutations in C. elegans pign-1 caused protein aggregation in the ER without affecting GPI-anchor biosynthesis. These results show that PIGN-1/PIGN has a conserved and non-canonical function to prevent deleterious protein aggregation in the ER independently of the GPI-anchor biosynthesis. PIGN is a causative gene for some human diseases including multiple congenital seizure-related syndrome (MCAHS1). Two pign-1 mutations created by CRISPR/Cas9 that correspond to MCAHS1 also cause protein aggregation in the ER, implying that the dysfunction of the PIGN non-canonical function might affect symptoms of MCAHS1 and potentially those of other diseases. © 2017. Published by The Company of Biologists Ltd.

A conceptual curriculum framework designed to ensure quality student health visitor training in practice.

PubMed

Hollinshead, Jayne; Stirling, Linda

2014-07-01

This paper describes the challenges faced by a trust in England following the introduction of the Health Visitor Implementation Plan. Two practice education facilitators designed a conceptual curriculum framework to ensure quality student health visitor education in practice. This curriculum complimented the excellent academic course already delivered by the University. A justification is provided for the design of the curriculum framework, including a rationale for the introduction of specific training sessions. Student and practice teacher feedback demonstrate the success of the introduction of this programme to ensure the development of student health visitors fit for practice. The conclusion places emphasis on the importance of continuous evaluation of the training programme to meet the needs of the students and the service.

Quantitative polymerase chain reaction (PCR) for detection of aquatic animal pathogens in a diagnostic laboratory setting

USGS Publications Warehouse

Purcell, Maureen K.; Getchell, Rodman G.; McClure, Carol A.; Weber, S.E.; Garver, Kyle A.

2011-01-01

Real-time, or quantitative, polymerase chain reaction (qPCR) is quickly supplanting other molecular methods for detecting the nucleic acids of human and other animal pathogens owing to the speed and robustness of the technology. As the aquatic animal health community moves toward implementing national diagnostic testing schemes, it will need to evaluate how qPCR technology should be employed. This review outlines the basic principles of qPCR technology, considerations for assay development, standards and controls, assay performance, diagnostic validation, implementation in the diagnostic laboratory, and quality assurance and control measures. These factors are fundamental for ensuring the validity of qPCR assay results obtained in the diagnostic laboratory setting.

Manipulation of follicle development to ensure optimal oocyte quality and conception rates in cattle.

PubMed

Baruselli, P S; Sá Filho, M F; Ferreira, R M; Sales, J N S; Gimenes, L U; Vieira, L M; Mendanha, M F; Bó, G A

2012-08-01

Over the last several decades, a number of therapies have been developed that manipulate ovarian follicle growth to improve oocyte quality and conception rates in cattle. Various strategies have been proposed to improve the responses to reproductive biotechnologies following timed artificial insemination (TAI), superovulation (SOV) or ovum pickup (OPU) programmes. During TAI protocols, final follicular growth and size of the ovulatory follicle are key factors that may significantly influence oocyte quality, ovulation, the uterine environment and consequently pregnancy outcomes. Progesterone concentrations during SOV protocols influence follicular growth, oocyte quality and embryo quality; therefore, several adjustments to SOV protocols have been proposed depending on the animal category and breed. In addition, the success of in vitro embryo production is directly related to the number and quality of cumulus oocyte complexes harvested by OPU. Control of follicle development has a significant impact on the OPU outcome. This article discusses a number of key points related to the manipulation of ovarian follicular growth to maximize oocyte quality and improve conception rates following TAI and embryo transfer of in vivo- and in vitro-derived embryos in cattle. © 2012 Blackwell Verlag GmbH.

Stability and Controls Analysis and Flight Test Results of a 24-Foot Telescoping Nose Boom on an F-15B Airplane

NASA Technical Reports Server (NTRS)

Moua, Cheng M.; Cox, Timothy H.; McWherter, Shaun C.

2008-01-01

The Quiet Spike(TradeMark) F-15B flight research program investigated supersonic shock reduction using a 24-ft telescoping nose boom on an F-15B airplane. The program goal was to collect flight data for model validation up to 1.8 Mach. In the area of stability and controls, the primary concerns were to assess the potential destabilizing effect of the oversized nose boom on the stability, controllability, and handling qualities of the airplane and to ensure adequate stability margins across the entire research flight envelope. This paper reports on the stability and control analytical methods, flight envelope clearance approach, and flight test results of the F-15B telescoping nose boom configuration. Also discussed are brief pilot commentary on typical piloting tasks and refueling tasks.

Controlling Neglected Tropical Diseases (NTDs) in Haiti: Implementation Strategies and Evidence of Their Success

PubMed Central

Lemoine, Jean Frantz; Desormeaux, Anne Marie; Monestime, Franck; Fayette, Carl Renad; Desir, Luccene; Direny, Abdel Nasser; Carciunoiu, Sarah; Miller, Lior; Knipes, Alaine; Lammie, Patrick; Smith, Penelope; Stockton, Melissa; Trofimovich, Lily; Bhandari, Kalpana; Reithinger, Richard; Crowley, Kathryn; Ottesen, Eric; Baker, Margaret

2016-01-01

Lymphatic filariasis (LF) and soil-transmitted helminths (STH) have been targeted since 2000 in Haiti, with a strong mass drug administration (MDA) program led by the Ministry of Public Health and Population and its collaborating international partners. By 2012, Haiti’s neglected tropical disease (NTD) program had reached full national scale, and with such consistently good epidemiological coverage that it is now able to stop treatment for LF throughout almost all of the country. Essential to this success have been in the detail of how MDAs were implemented. These key programmatic elements included ensuring strong community awareness through an evidence-based, multi-channel communication and education campaign facilitated by voluntary drug distributors; strengthening community trust of the drug distributors by ensuring that respected community members were recruited and received appropriate training, supervision, identification, and motivation; enforcing a “directly observed treatment” strategy; providing easy access to treatment though numerous distribution posts and a strong drug supply chain; and ensuring quality data collection that was used to guide and inform MDA strategies. The evidence that these strategies were effective lies in both the high treatment coverage obtained– 100% geographical coverage reached in 2012, with almost all districts consistently achieving well above the epidemiological coverage targets of 65% for LF and 75% for STH—and the significant reduction in burden of infection– 45 communes having reached the target threshold for stopping treatment for LF. By taking advantage of sustained international financial and technical support, especially during the past eight years, Haiti’s very successful MDA campaign resulted in steady progress toward LF elimination and development of a strong foundation for ongoing STH control. These efforts, as described, have not only helped establish the global portfolio of “best practices” for NTD control but also are poised to help solve two of the most important future NTD challenges—how to maintain control of STH infections after the community-based LF “treatment platform” ceases and how to ensure appropriate morbidity management for patients currently suffering from lymphatic filarial disease. PMID:27706162