Risk Management Report

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1、FRND-SOP-002-01-03Page4of17/FRND-SOP-002-01-03第4页共17页RiskManagementAnalysisEvaluationReportNo序号QuestionsDescription问题描述Identify判定ConclusionDescription结论描述ＸＸＸＸ公司FORM表格DocumentNo.文件号:FRND-SOP-002-01-03RISKMANAGEMENTANALYSISEVALUATIONREPORT风险管理分析、评价、报告Effective

2、Date生效日期:2011-07-28Page页码：Page1of17FileNo文档编号FinalizationDate定稿日期:□AnalysisandEvaluation□ReportAssignmentofResponsibility职责分工Position职务：Signature签名：Date日期：DrawUp编制人:ProjectLeader项目负责人:Participator参与人:一Riskmanagementteam风险管理团队Name姓名Assignmentofresponsibility职责和权限

3、二Productinstruction产品介绍Productname产品名称Productmodelorcode产品型号或物料代码Intendeduse预期用途Mainstructure主要结构Mainmaterials主要材料Workenvironment使用环境三Riskevaluationcriteria风险评价准则(参考)FRND-SOP-002-01-03Page4of17/FRND-SOP-002-01-03第4页共17页RiskManagementAnalysisEvaluationReportNo序

4、号QuestionsDescription问题描述Identify判定ConclusionDescription结论描述Table1–Exampleoffivequalitativeseveritylevels表1-严重度5级举类Severity严重度Criteriadescription标准描述Ranking等级Catastrophic灾难性的Resultsinpatientdeath导致患者死亡5Severe危重的Resultsinpermanentimpairmentorlife-threateninginjur

5、y导致永久型损伤或危及生命的伤害4Critical严重Resultsininjuryorimpairmentrequiringprofessionalmedicalintervention导致要求专业医疗介入的伤害或损伤3Marginal轻度Resultsintemporaryinjuryorimpairmentnotrequiringprofessionalmedicalintervention导致不要求专业医疗介入的暂时伤害或损伤2Negligible可忽略Inconvenienceortemporarydisco

6、mfort不方便或暂时不适1Table2–Exampleofsemi-quantitativeprobabilitylevels表2–概率6级示类Probabilitylevels可能性Criteriadescription标准描述Ranking等级Frequent经常≥10-16Probable有时≥10-25Occasional偶然＜10-2and≥10-34Rare很少＜10-3and≥10-43Remote非常少＜10-4and≥10-62Improbable极少＜10-61Table3–DetectionCl

7、assifications表3–探测度5级示类Detectionlevels探测度Criteriadescription标准描述Ranking等级FRND-SOP-002-01-03Page4of17/FRND-SOP-002-01-03第4页共17页RiskManagementAnalysisEvaluationReportNo序号QuestionsDescription问题描述Identify判定ConclusionDescription结论描述AlmostCertain几乎确定Almostcertainlyd

8、etectapotentialcause/mechanismandsubsequentfailuremode几乎确定可探测到潜在失效原因／机理和引发的失效模式1High高Highchancedetectapotentialcause/mechanismandsubsequentfailuremode有高的可能性探测到潜在失效原因／