Quality assurance (San Diego, Calif.)最新文献

One of the challenges facing professionals in the environmental arena today is the collection and assessment of large amounts of environmental analytical data. The assessment of the quality of that data is essential as multi-million dollar decisions for environmental site cleanups and/or long term monitoring efforts are made based on the analytical results. Also critical to environmental programs is the sharing and access of data across multiple data users. The ability to share data allows for better use of the limited resources available to clean up and monitor contaminated environmental sites. Standardization of electronic deliverables allows for collection of data from multiple data collectors into a single database for use by numerous data users and stakeholders on a project. This paper discusses the benefits of using a standard EDD deliverable format and use of environmental data assessment software tools to do project planning and data assessment throughout the duration of the environmental project.

The EPA Supersites Research Program needs consistency of metadata and data structures to facilitate information sharing among investigators, analysts, and ultimately secondary data users. Under the auspices of NARSTO a successful mechanism was created to develop and implement reporting standards. The development effort included working closely with Supersites data coordinators, investigators, and technical experts, and also leveraging from existing data standards and practices. Overall, the standards are getting good acceptance from the atmospheric research community.

EPA and other government organizations make decisions based on environmental measurements. How good are the data? How well are the data generators performing? What measurements apply to them? How can the data life cycle processes be improved so data generators can continually provide the best data? EPA's Quality Management System requirements go beyond evaluation of environmental data quality itself to examine systems associated with production, collection, processing (validation/verification), transfer, reduction, storage, and retrieval of data throughout a life cycle. This QMS specifies minimum quality requirements for particular environmental programs. But how can you measure and compare programs that go well beyond the minimum, towards optimal quality? This paper compares EPA's requirements for Quality Management Systems (R2) and Project Plans (R5) to the Software Engineering Institute Capability Maturity Model (CMMISM). The CMMISM model provides for growth (staged or continuous) and a comprehensive assessment that is not yet provided in EPA's R2 or R5. Properly implemented, the CMMISM model serves as a quality framework for integrating and aligning organizational processes and implementing a program of continual process improvements. It identifies process areas ("things to do"), and provides measures of performance ("how well things are done") against specific goals and practices. CMMISM uses a Systems Engineering Management approach, built on process models, that helps identify "how good" the system is. Goodness is defined as stages in a complete model for optimal operation. CMMISM provides two methods for evaluating the goodness of the project. The Staged model in CMMISM provides a Maturity Level that is a well-defined evolutionary plateau describing the manner in which a specified set of processes are performed. As the organization advances in maturity, these levels become more defined and processes are tailored for specific project needs. The other method is called the Continuous Model in CMMISM, and it allows you to achieve Capability Levels. These are used to describe how well each project is doing in relationship to the different process areas. There are six Capability Levels from 0-5 that apply to individual process areas. Organizations using the Capability Level approach can select individual process areas that are important to specific projects and work to improve the processes. Improving capability in individual process areas raises the organization's overall quality of products delivered. The Continuous Model, unlike the Staged Model, lets you pick higher maturity level process areas before completing all of the ones below. Environmental measurement programs need to focus on the quality of the systems where data are collected, processed, transferred, and so forth. DynCorp built on the quality foundation from our experience with R2 to successfully implement CMMISM practices in the development of Forms II Lite and other appli

The Environmental Protection Agency's Strategic Plan was developed in response to internal and external concerns about the integrity, consistency, and accuracy of EPA's environmental data. This document explains why a Strategic Plan is needed and the methodology used in its development, cites Agency models of excellence, and presents the six recommendations of EPA's Data and Information Quality Strategic Plan.

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

A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical Practice (EFGCP). Auditing requirements in these recent guidelines and the EU Clinical Trial Directive are discussed as well as the methodology and type of documentation and SOPs that should be present at an audit. It is argued that both inspectorates and independent auditors need to conduct such audits to improve the overall global standard.

The US Environmental Protection Agency-National Enforcement Investigations Center (NEIC) of Denver, Colorado is the specialty technical arm of the Office of Enforcement and Compliance Assurance (OECA) within the US EPA. NEIC is a center for technical support nationwide to state, local, tribal, and federal environmental enforcement and compliance assurance programs. NEIC is a source of expertise for technical analysis, compliance monitoring, engineering evaluations, forensic laboratory activities, information management, computer forensics, and witness testimony. Effective 1 February 2001, NEIC was granted accreditation for overall environmental measurement activities that include field sampling, field measurements and monitoring, and laboratory measurements. NEIC became the first and only environmental forensic center in the United States to be granted this type of accreditation. The accreditation criteria incorporates nationally and internationally accepted forensic and quality management standards. Awarded by the National Forensic Science Technology Center (NFSTC), the NEIC Accreditation Standard was developed for conducting environmental measurements while adhering to forensic requirements in specific areas. The NEIC Accreditation Standard is based on ISO/IEC Guide 25 and ANSI/ASQC E4-1994, and it references specific aspects of the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) Manual.

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

To obtain high quality products at low cost and in a short time is an economical and technological challenge to today's engineering community. Design of Experiments based on the Taguchi approach is a powerful technique to attain this objective. In some processes, it is necessary to consider not only two factors but also the ratio of their levels 'as a factor.' This paper introduces a new look at the Taguchi method that makes it possible, by choosing the proper levels, to evaluate the ratio of two factors as a new factor in the same orthogonal array. An experiment to study four three-level factors was designed, and a case study is presented to illustrate the ratio of the two three-level factors as a new factor using the same L9 orthogonal array.

The IR-4 Project is dedicated to all aspects of minor crop pest management, in cooperation between USDA, universities, and other state or Federal entities. Human safety decisions made by EPA are based upon field raw data, analytical reports, and scientific review and interpretation. Quality Assurance personnel, an independent body of internal inspectors and auditors, assist both regulatory inspector and on-site field personnel during EPA site inspections. This article contains information gleaned from a large number of university and other test site inspections, which were conducted by EPA to fulfill requirements of Good Laboratory Practice regulations, 40 CFR 160.