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

Quality, occupational health and safety, and environmental issues are three key areas that, along with productivity and service, must be managed effectively. Organizations face the need to develop integrated systems for the management of these areas. As organizations increasingly need to seek efficiencies, one field in which such integration can bring considerable gains is training. The present paper examines how the requirements for training in different areas overlap and how an integrated training program may be developed.

Research papers and reports written by scientists and engineers in the United States Environmental Protection Agency are reviewed by the agency's quality assurance staff. EPA papers and reports are subjected to peer reviews that check for the validity of conclusions and the general agreement with the body of technical knowledge in the subject area. Quality assurance reviews differ from peer reviews in that the focus of the quality assurance review is on the following criteria: Consistency: Were reasonable and consistent units of measurement and generally acceptable formulas used throughout? Are the appropriate number of significant figures reported? Correctness: Were matrix-compatible methods used? Were measurements within the working range of the method? Can measurements be traced to a recognized standard or source (e.g., the National Institute of Standards and Technology)? Can calculations be verified, starting from representative raw data and proceeding to the summary data presented in the paper or report? Coherence: Do the stated conclusions follow from the data presented? Are the assumptions clearly stated? Are inconsistencies between data and conclusions discussed? Clarity: Are special terms and acronyms defined? Can a person with a general technical background in the subject understand the paper or report? Conformance: Did the study follow the test/quality assurance plan, with appropriate calibrations and other quality-control checks, audits, and data validations? If not, is there a discussion of problems? Concordance: Were data quality objectives met? Were the data quality indicator goals achieved for precision, accuracy, representativeness, comparability, and completeness? The importance of these quality assurance review criteria are discussed along with examples from current work.

Many Saudi companies, in their journey to improve quality, efficiency and competitiveness, are pursuing and obtaining the ISO 9000 certificate. Many studies have evaluated how to implement ISO 9000 in different sectors, but none have analyzed the effectiveness of ISO 9000 certification (costs and benefits) on improving the overall quality and on meeting expectations. This study addressed these issues by investigating manufacturing organizations in Saudi Arabia that have the ISO 9000 certification. A survey questionnaire was distributed to firms throughout the kingdom. Thirty-two firms participated in the study. Results indicate that increased consistency of operations, improved service, and product quality are among the top motivators for pursuing the ISO certificate. The benefits most often experienced were improved awareness of procedural problems, better management control, keeping existing customers, increased customer satisfaction, and improved customer service. Difficulties experienced during the certification process involved time and cost, but these were not considered to be major problems. A high volume of paperwork was the main problem experienced following initial certification. Respondents in general said that the ISO 9000 certification met their expectations and that their level of satisfaction regarding the impact of ISO 9000 was high. Most recommended that other organizations pursue the certificate.

The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health.

A technique known as Statistical design of experiments is a powerful technique for process characterization, optimization, and modeling. It has been widely accepted in manufacturing industry for improving product performance and reliability, process capability, and yield. This article illustrates the application of statistical design of experiments based on the Taguchi approach in a certain company that manufactures electromagnetic clutch coils. The objective of the study was to improve the quality of the existing process and thereby achieve heightened customer satisfaction for the product. An eight-trial experiment was conducted with the aim of reducing the number of rejects from the process. The expected savings per month was estimated to be over $11,500. The results of the study have provided a greater stimulus for the wider application of statistical design of experiments in other core processes within the company.

Quality-assurance inspections are necessary to assure that studies are conducted according to protocol, standard operating procedures, (SOPs) and government regulations. This article describes observation methods used when conducting inspections, the basic steps of an inspection, and the seven inspection principles (protocol, SOPs, reagents/drugs/test article, equipment, personnel, facility, and management) used to complement and standardize an in-process inspection. In addition, differences among preclinical, clinical, and analytical study inspections are discussed and helpful tips are identified.

Verification of balance accuracy entails applying a series of standard masses to a balance prior to use and recording the measured values. The recorded values for each standard should have lower and upper weight limits or tolerances that are accepted as verification of balance accuracy under normal operating conditions. Balance logbooks for seven analytical balances at the Upper Mississippi Science Center were checked over a 3.5-year period to determine if the recorded weights were within the established tolerance limits. A total of 9435 measurements were checked. There were 14 instances in which the balance malfunctioned and operators recorded a rationale in the balance logbook. Sixty-three recording errors were found. Twenty-eight operators were responsible for two types of recording errors: Measurements of weights were recorded outside of the tolerance limit but not acknowledged as an error by the operator (n = 40); and measurements were recorded with the wrong number of decimal places (n = 23). The adherence rate for following tolerance limits was 99.3%. To ensure the continued adherence to tolerance limits, the quality-assurance unit revised standard operating procedures to require more frequent review of balance logbooks.

A quality-management program (QMP) has been launched at the Naval Medical Research Institute Toxicology Detachment to support the planning, assessment, interpreting, and reporting of toxicology study data. The QMP conforms to the intent of the Good Laboratory Practice established by the Food and Drug Administration and the Environmental Protection Agency for regulatory compliance. The biomedical data necessary to characterize the toxicity of materials of interest to the Navy are used to formulate occupational and environmental health-hazard evaluations and risk assessments, including appropriate exposure limits for personnel for Navy-specific circumstances of exposure. The goal of the QMP is to help management and investigators ensure the quality and integrity of the data collected in laboratory animal toxicology studies. These data are used to reduce or eliminate potential health risks from exposure to toxicants during Navy operations. The primary purpose of the risk-reduction program is to help ensure readiness to accomplish the military mission. This article briefly reviews the need for the QMP and the military relevance of the quality-assurance requirements. The pros and cons of establishing the QMP are discussed, and examples of specific research projects and programs that support the need for a quality management program are presented. Aspects of integrating the QMP program to ensure compliance with Good Laboratory Practice are reviewed, and the value of the improvements in the quality of data from the Naval Medical Research Institute/Toxicology Detachment is summarized.

Infinite growth cannot continue on a finite planet. One reason is that human society is dependent on a life-support system that is both technological and ecological. Ecosystem services (including regeneration of topsoil, maintenance of atmospheric gas balance, cleansing of water, and maintenance of a genetic library to meet climate changes, whether induced by humans or by nature) are provided by nature. In meeting the perceived needs of human society, the ability of the ecological life-support system to deliver services may be compromised. To prevent this, human society will have to undergo major changes in behavior. Change will be facilitated if a common sustainability paradigm is accepted to meet certain conditions and goals. The main goal is to provide human descendants with a habitable planet, and this entails protecting natural systems that provide necessary life-support functions. If this goal is accepted, then a number of supporting goals can be stated and the conditions necessary to meet these goals can be outlined.

This article presents an integrative approach, using toxicological and chemical analyses, to screen for toxic substances that could be illegally added to the chemical-toilet sludge received at the wastewater treatment plant of the Montreal urban community. Four toxicity tests (Microtox, bacterial-respiration, root-elongation, and seed-germination tests) were used to establish the toxicity range of a "normal" sludge and the determination of threshold limits criteria. Chemical-toilet sludge samples were spiked with two types and amounts of contaminants (zinc, phenol). Conservative criteria were used to detect abnormal toxicity with great reliability and avoid false positives (i.e., detecting abnormal toxicity in nonspiked sludge). Taken individually, the seed-germination test was the least discriminating toxicological method (detecting only 10% of the spiked samples); the bacterial-respiration test was relatively better (detecting 72% of the spiked samples). Using a limited battery of two toxicity tests (Microtox and respiration test), the identification of contaminated chemical-toilet sludge can be detected with good efficiency and possibly great reliability (more than 80% of the spiked samples). This proposed procedure is efficient, easy to apply, cost-effective, and very fast (an abnormal toxicity level can be determined within a few hours).