Quality assurance最新文献

{"title":"Controversy over genetically modified organisms: the governing laws and regulations.","authors":"K. L. Keatley","doi":"10.1080/105294100753209174","DOIUrl":"https://doi.org/10.1080/105294100753209174","url":null,"abstract":"Genetically Modified Organisms (GMOs) are increasingly becoming a topic of controversy in the U.S. and abroad. The public is questioning their safety and wanting the products labeled as genetically modified. There are other concerns from some of the scientific world and some government officials and organizations such as the Food & Agricultural Organization (FAO) that question whether adequate research has been done to qualify GMOs as safe for long-term use. Of particular concern are the allergenic properties, a GMO may impart, possible transfer effects of antibiotic resistance (given that antibiotic resistant marker genes are used for many GMOs), the expression of previously unexpressed traits, and the drift of pollen from genetically modified crops. It has also been noted that the laws and regulations governing the biotechnology world are outdated, are not comprehensive, and span too many agencies. The primary agencies currently regulating biotechnology are the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2000-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80501360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designation of a GLP facility by the Korean Ministry of Environment GLP authority: the case of the Center for Occupational Toxicology.","authors":"I. Yu, S. Maeng, J. Y. Lee, Y. M. Lee, H. K. Chung","doi":"10.1080/105294100753209156","DOIUrl":"https://doi.org/10.1080/105294100753209156","url":null,"abstract":"In this report, the process of designating a GLP facility by the Korean Ministry of Environment (MOE) is described in detail using the case of the Center of Occupational Toxicology (COT). The COT, which had been prepared as a GLP facility, filed an application to the National Institute of Environmental Research (NIER) of the MOE. The GLP system of the COT was evaluated by a harmonized evaluation team that consisted of several authorities including the NIER, the National Institute of Agricultural Science and Technology (NIAST), and the National Institute of Toxicological Research (NITR). The evaluation was arranged for mutual acceptance of data among GLP authorities. The designation process, additional documents necessary for applying GLP facility, the process of test facility evaluation including reviewing the application and site inspection, and inspection results and submission of correction plans are explained by using the instance of the inspection process of the COT. COT was evaluated as a suitable GLP facility for acute oral and inhalation toxicity tests and the Ames test.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2000-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76060160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The transformation of Lebanese firms from ISO 9000 certified to TQM.","authors":"T. Mezher","doi":"10.1080/105294100753209183","DOIUrl":"https://doi.org/10.1080/105294100753209183","url":null,"abstract":"Over the past decade, the most effective method of implementing a quality system has been ISO 9000 certification. Lebanese companies have recently followed the same path of adopting and improving their status in quality systems. The overwhelming belief is that ISO 9000 is, by itself, not enough. It is a first stepping-stone in the road to business excellence, but ISO 9000 does not guarantee an improvement in the product or service being offered. All indications are that Total Quality Management (TQM) is the method for improving quality as a whole. This improvement is, of course, entirely reliant on the proper implementation and understanding of the scope and underlying objectives. The relatively new adoption of TQM as an effective tool in the struggle to achieve substantial improvements in quality is made clear in the results of a survey that are presented in this article. Recommendations as how to make the transition between ISO 9000 and TQM are made, and a discussion is provided of the need for organizational change, both internal and external, within companies in the Lebanese market. The aim of this work is to present a clear representation of what is actually occurring within the Lebanese domestic market with regards to the understanding the TQM philosophy.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2000-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80247604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is ICH exportable outside the European Union?","authors":"N. Dent","doi":"10.1080/105294100753209165","DOIUrl":"https://doi.org/10.1080/105294100753209165","url":null,"abstract":"This article sets out to explore whether or not the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are exportable outside the European Union (EU). It is not a question of whether the Guidelines per se are exportable but rather can studies outside the EU be performed to the same, or a better standard? It is well known that the ICH Guidelines are accepted worldwide in the countries where International Clinical Trials are carried out. Likewise with the signatories to the Step 5 document being the major players--the USA, Japan, and Europe--the guidelines are already enshrined in national legislation. The author therefore sets out to address whether clinical trials can be conducted to the ICH GCP standard outside Western Europe. The facts and opinions presented here are based on a 16 centre (of which eight of the centres were required to be audited by the Sponsor) clinical study that was carried out in both the Czech Republic and Poland for nonseasonal rhinitis. The recruitment of patients was required to take place in a short period of time and had strict inclusion and exclusion criteria. The overall concept of the study and the compliance with internationally accepted ICH GCPs was found to be of a very high standard. In addition, several other studies from totally different therapeutic areas, clearly show that the standard in non-EU countries is equally high and in most cases of a higher standard than is seen at the principal investigators sites within the EU. In what Western Europeans like to call \"developing countries,\" an understanding of the international GCPs has already been grasped and extremely high quality clinical trials are being carried out. To demonstrate this, attention is drawn to a large head and neck cancer study that was part device and part pharmaceutical product and was conducted in conjunction with photodynamic therapy (PDT), carried out in several countries, but of note in India.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2000-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91065202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validating existing data in the Environmental Technology Verification Program.","authors":"S. Wasson","doi":"10.1080/105294199750061317","DOIUrl":"https://doi.org/10.1080/105294199750061317","url":null,"abstract":"Establishing the credibility of existing data is an ongoing issue, particularly when the data sets are to be used for a secondary purpose, i.e., not the original reason for which they were collected. If the secondary purpose is similar to the primary purpose, the potential user may have little difficulty establishing credibility since the acceptance criteria for both purposes should be similar. If the secondary purpose is different, then data credibility may be more difficult to establish because the experiment generating the data may not have been conducted optimally for the secondary purpose and all of the necessary quality assurance data (\"metadata\") may not have been collected. In either case, a process will be required to determine the acceptability of the data. For this reason, at the time the U.S. Environmental Protection Agency (EPA) Environmental Technology Verification (ETV) program was established, similar certification and verification programs run by states or foreign countries routinely used existing data sets, for cost reasons, rather than generate new data by testing. The issue of whether existing data could be used in the ETV program immediately surfaced. In response, a policy and a process that addressed existing data were written and published in Appendix C of the ETV Quality and Management Plan (Hayes et al., 1998). This paper discusses how the ETV program determines the credibility of existing data used to verify the performance of environmental technologies.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72600144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality science and quality assurance: observations of an environmental scientist.","authors":"T. J. Hughes","doi":"10.1080/105294199750061344","DOIUrl":"https://doi.org/10.1080/105294199750061344","url":null,"abstract":"The purpose of this manuscript is to examine the relationship between quality science (QS) and quality assurance (QA). Many research scientists definitely want to do QS, but are afraid or do not want to do QA because they are intimidated by the QA process or they do not appreciate the benefits of QA. Therefore, the relationship between QS and QA is examined in this manuscript by an environmental scientist who has conducted 30 years of research in university, contract and government laboratories. To start, QS is defined in this paper as data that are published in the peer-reviewed literature. The quality of the research data is assumed by the general scientific population to be directly proportional to the status of the journal. For example, it is highly prestigious to have an article published in Science. At the U.S. EPA, the procedure for sending a manuscript to a journal for publication is the responsibility of the senior author. The senior author of an EPA-sponsored manuscript is expected to have the manuscript reviewed by the coauthors (they should also review the data), then the manuscript must be reviewed by at least two other scientists, one of whom must be from outside the authors' division. After this review and approval by management, the manuscript is sent to a peer-reviewed journal, where it is reviewed by several anonymous scientists as determined by the journal. After the comments of the reviewers are addressed, the manuscript can either be accepted or rejected for publication by the journal. For the purpose of this manuscript, the definition of QA is defined as the guarantee from a review team that the entire study was adequately and correctly conducted and recorded according to the study protocol. Many scientists view QS and QA as separate entities. From the scientist's perspective, QA procedures are not applicable to research studies, and should be used only for studies that will be submitted to either the EPA or the FDA for regulatory approval (i.e., Good Laboratory Practice [GLP] studies). However, QA can be applied to both types of studies. A QA review will examine all aspects of the study including data files (notebooks, protocols), as well as equipment, sample storage, actual experimental organisms (animals or cells) and the management of all study records. The data from a QA-reviewed study are therefore more defensible in a court of law, and more reproducible due to more through, chronological records. Generally speaking, few coauthors of a scientific manuscript analyze the raw data in the laboratory notebooks or inspect the laboratory equipment. Furthermore, coauthors generally have not been in the laboratory where the research was conducted in order to observe quality control measures. These are the areas where a QA review is extremely beneficial. In summary, data in the peer-reviewed literature do not undergo the same type of review as do data that have undergone a QA review. QA reviews assist EPA scientists in conductin","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76756364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Never audit alone--the case for audit teams.","authors":"N. Adams","doi":"10.1080/105294199750061308","DOIUrl":"https://doi.org/10.1080/105294199750061308","url":null,"abstract":"UNLABELLED\u0000On-site audits, conducted by technical and quality assurance (QA) experts at the data-gathering location, are the core of an effective QA program. However, inadequate resources for such audits are the bane of a QA program and, frequently, the proposed solution is to send only one auditor to the study site. There are several reasons why audits should be performed by more than one person: 1.\u0000\u0000\u0000SAFETY\u0000Audits of EPA projects frequently involve hazardous chemicals or other environmental hazards. They also often involve working after normal work hours in remote locations with dangerous equipment. It is unsafe to work alone under such conditions. 2. Skills: Many of EPA's projects are multidisciplinary, involving multiple measurements systems, several environmental media, and complex automated data collection and analysis systems. It is unlikely that one auditor would have the requisite skills to assess all of these operations. 3. Separateness: Two auditors can provide two (sometimes differing) perspectives on problems encountered during an audit. Two auditors can provide complementary expertise and work experience. Two auditors can provide twice the surveillance power. 4. Support: The operations that need to be assessed are sometimes in different parts of a site, requiring two auditing devices or considerable commuting time. Also, auditors are occasionally diverted by managers wishing to show their best efforts rather than the whole operation; if two auditors are on-site, one can interview managers while the other talks with technical staff. If there is a dispute, one auditor can support the other in verifying observations. 5. Savings: Although sending one auditor is perceived to be a cost-saving measure, it may be more economical to send two auditors. Time on site (lodging, food) is decreased, more of the project is assessed in one visit, less pre-audit training is required, and report preparation is accelerated. In summary, sending more than one auditor on a field audit is smarter, safer and more effective, and can be less expensive in the long run.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83543424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality assurance growing pains: a state perspective on implementing an organizational-wide quality system in environmental laboratories.","authors":"S. Siders","doi":"10.1080/105294199750061326","DOIUrl":"https://doi.org/10.1080/105294199750061326","url":null,"abstract":"To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Once development of a quality system has been sanctioned, a team-based approach utilizing project planning tools is a good way to approach the effort. Resources are assigned to the development of key quality system components, and generally a phased-deployment or roll-out works best. Once implementation is underway, assuring operational utilization and compliance with the quality system are vital steps in the process. Important to successful implementation is ongoing assessment and refinement of the quality system. Fundamental and key elements of the laboratory quality system are numerous and need to work in concert with each other. Quality system elements to be discussed in the presentation range from management and QA roles and functions to the typical documentation of laboratory policies and procedures. Numerous QA assessment tools and other vital quality system practices that play an important role in making a complete quality system are addressed. In addition, efforts must be undertaken to integrate the laboratory quality system with other management systems within the organization. The bottom line is that all environmental laboratories need a quality system more now than ever. Data users need it. Customers' expectations for data quality are high. USEPA policy and/or programs call for it. Additionally, good quality systems can benefit the organization in multiple ways and help avoid the \"pay-me-now or pay-me-later\" syndrome. In conclusion, all environmental testing laboratories (i.e., academic, private, commercial and especially governmental) need to invest in and implement a quality system based on a recognized standard (e.g., NELAC, ISO 17025, ANSI/ASQC E-4). The author recommends pursuing NELAP laboratory accreditation with a NELAP-recognized accrediting authority.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88346765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Data quality objectives in environmental research planning.","authors":"A. R. Batterman, S. Batterman, K. M. Jensen, F. W. Whiteman","doi":"10.1080/105294199750061290","DOIUrl":"https://doi.org/10.1080/105294199750061290","url":null,"abstract":"This paper presents highlights of a Data Quality Objectives course relating the Environmental Protection Agency's (EPA) seven step research planning process to research efforts at the U.S. EPA National Health and Environmental Effects Research Laboratory, Mid-Continent Ecology Division, in Duluth, Minnesota. Introductory materials were derived from \"Guidance for the Data Quality Objectives Process, EPA QA/G-4.\" Case studies illustrate decisions that were made during the systematic planning process and subsequent experimentation. This paper demonstrates how the Data Quality Objectives Process clearly links research goals and objectives with the final product. Application of the process to environmental research ensures that environmental research data are of known, credible, defensible and usable quality.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83119397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research integrity: a government perspective.","authors":"Linda S. Birnbaum, Brenda T. Culpepper","doi":"10.5840/PROFETHICS1999715","DOIUrl":"https://doi.org/10.5840/PROFETHICS1999715","url":null,"abstract":"What is research integrity? At the United States Environmental Protection Agency (U.S. EPA) research integrity can be defined as conducting and fostering research to define, anticipate, and understand environmental problems; and generating sound, appropriate, credible, and effective solutions to those problems. Whether in government, academia, or industry, integrity is required at all stages of research--from data generation to data analysis. What constitutes research integrity? Simply put, Did we do the right thing? Did we do it the right way? Did we honestly document what we did? This is especially important if the research is used as a basis for public policy. The extensive and intensive use of the results of science in EPA's standard setting, regulatory, and enforcement responsibilities means that scientific misconduct can lead to costly and inappropriate actions through unnecessary expenditure or inadequate protection. The soundness, effectiveness, and credibility of EPA's regulations ultimately rest on the scientific and technical bases for these actions. Careful attention to research record keeping can help ensure data quality and integrity. The U.S. Environmental Protection Agency, its research requirements, and the work of the National Health and Environmental Effects Research Laboratory are discussed below.","PeriodicalId":20856,"journal":{"name":"Quality assurance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"1999-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80581083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}