Article(id=1242136060449334228, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1242136040736109467, articleNumber=null, orderNo=14, doi=10.3981/j.issn.1000-7857.2017.10.009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1453219200000, receivedDateStr=2016-01-20, revisedDate=1467734400000, revisedDateStr=2016-07-06, acceptedDate=null, acceptedDateStr=null, onlineDate=1495691321933, onlineDateStr=2017-05-25, pubDate=1495900800000, pubDateStr=2017-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1495691321933, onlineIssueDateStr=2017-05-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774077914576, creator=sys-migrate, updateTime=1774077914576, updator=sys-migrate, issue=Issue{id=1242136040736109467, tenantId=1146029695717560320, journalId=1146031591421210625, year='2017', volume='35', issue='10', pageStart='1', pageEnd='108', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=3, issueType=-1, specialIssue=null, createTime=1774077909878, creator=sys-migrate, updateTime=1774077909878, updator=sys-migrate, preIssue=null, nextIssue=null, ext=null, issueFiles=null}, startPage=71, endPage=75, ext={EN=ArticleExt(id=1242136063309849584, articleId=1242136060449334228, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Solutions to treatment for out of specification of bacterial endotoxin test, columnId=1242116080374710456, journalTitle=Science & Technology Review, columnName=Articles, runingTitle=null, highlight=null, articleAbstract=A series of scientific methods are established to confirm the out of specification (OOS) result which is inevitable in daily detection for bacterial endotoxin test. According to the risk factor analysis and work experience, the causes of OOS results are analyzed and details of quality standard and calculation, experimental operation, materials, instruments, etc. are studied. Based on the characteristics of bacterial endotoxin test, a decision flow chart is designed to determine the validation scheme for OOS. All types of causes and solutions for risk factors are determined, and the risk factor fishbone diagram to review OOS and a decision-making flowchart to verify OOS results are established. This work makes the endotoxin test results more scientific and rigorous by using the fish bone diagram of risk factors to review and analyze the causes of OOS and by following the decision-making flow chart to confirm the result., correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=8ATptWp4RUdeH4hKpZkWCw==, pdfFileSize=2571238, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=National Institutes for Food and Drug Control, Beijing 100050, China, fund=null, authors=PEI Yusheng, CAI Tong, ZHANG Guolai, GAO Hua, authorsList=PEI Yusheng, CAI Tong, ZHANG Guolai, GAO Hua), CN=ArticleExt(id=1242136062177387497, articleId=1242136060449334228, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=细菌内毒素检查法超标结果的处理方法, columnId=1146540929516700224, journalTitle=科技导报, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=内毒素检测结果超过质量标准规定（OOS）的情况在日常检测中不可避免。通过风险因素分析法，结合大量实际工作经验，对产生OOS的原因进行了逐项分析和研究，包括质量标准与计算、实验操作、材料与仪器等因素。针对内毒素检查的特性，设计决策流程图确定验证OOS方案。确定了所有类型的风险因素产生原因和解决方法，建立了用于回顾细菌内毒素OOS的风险因素鱼骨图和用于验证OOS结果的决策流程图。按建立的方法进行验证处理OOS，能够使内毒素检测结果更加科学严谨。, correspAuthors=null, authorNote=裴宇盛,助理研究员,研究方向为药检药理,电子信箱:pysh@nifdc.org.cn。, correspAuthorsNote=高华(通信作者),研究员,研究方向为药检药理,电子信箱:huag55@163.com, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=H+aSf+hNS7bpuwG+ghMMWw==, pdfFileSize=2571238, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=中国食品药品检定研究院, 北京 100050, fund=国家科技重大专项项目（2015ZX09303001）, authors=裴宇盛, 蔡彤, 张国来, 高华, authorsList=裴宇盛, 蔡彤, 张国来, 高华)}, authors=null, keywords=[Keyword(id=1242136061854426083, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136060449334228, language=CN, orderNo=1, keyword=细菌内毒素检查法), Keyword(id=1242136061938312165, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136060449334228, language=CN, orderNo=1, keyword=质量管理), Keyword(id=1242136062013809639, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136060449334228, language=CN, orderNo=1, keyword=超过质量标准规定), Keyword(id=1242136063016248301, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136060449334228, language=EN, orderNo=1, keyword=bacterial endotoxin test), Keyword(id=1242136063095940078, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242136060449334228, language=EN, orderNo=1, keyword=quality management), 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