HACCP工艺风险评估报告模板.doc

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1、DocumentName文件名称RiskAssessmentReportforXXXProcessXXX工艺风险评估报告DocumentNo.文件号Page页码RA-XXX-00Page24of28RiskAssessmentReportforXXXProcessXXX工艺风险评估报告ReportApproval报告批准Company/Title公司/职务Name姓名Signature签名Date日期Writtenby编写Reviewedby审核Approvedby批准DocumentName文件名称RiskAssessmentReportforXXXProcessXXX工艺风险评估报

2、告DocumentNo.文件号Page页码RA-XXX-00Page24of28RevisionHistory版本修订索引Rev.版本Date日期RevisionReasons修订原因002011/10/30Initialissuance新制订DocumentName文件名称RiskAssessmentReportforXXXProcessXXX工艺风险评估报告DocumentNo.文件号Page页码RA-XXX-00Page24of28Index目录1Overview概述42Purpose目的43Scope范围44Responsibility职责45Abbreviations缩略语6

3、6RegulationandGuidance法规和指南77SystemDescription系统描述97.1PlantDescription车间概述97.2ProductInformation产品信息107.3Equipments/SystemList设备/系统清单158ReferenceDocuments参考文件169RiskAssessmentMethod风险评估方法179.1ConductaHazardAnalysis进行危害分析179.2DeterminetheCriticalControlpoints(CCPs)关键控制点的确认209.3EstablishTargetLeve

4、lsandCriticalLimits建立目标水平和关键限值219.4EstablishSystem(s)tomonitoringCCP建立CCP监测系统219.5EstablishanappropriateCorrectiveActionPlan建立适当的纠正计划229.6EstablishProcedures建立规程229.7EstablishDocumentationandkeeprecords建立文件并保留记录2310HazardanalysisMatrix危害分析矩阵2511CCPControlMatrix关键控制点控制矩阵2612Conclusion结论&建议27Docum

5、entName文件名称RiskAssessmentReportforXXXProcessXXX工艺风险评估报告DocumentNo.文件号Page页码RA-XXX-00Page24of28Overview概述ThisdocumentsummarizesthequalityriskmanagementreportforXXXattheXXXsite.ThedocumentembracestheprinciplesofICHQ9(QualityRiskManagement)andusesriskmanagementtoolstosupportmanufacturingstrategiesd

6、esignedtominimizeriskstoproductquality.本文件总结了位于XXX的XXX的质量风险管理报告。本文件包括ICHQ9（质量风险管理）的原则以及使用合适的风险管理工具来支持设计用于将对产品质量的风险降到最低的生产策略。AformalizedriskmanagementapproachwasappliedtotheXXXmanufacturingfacility.Thisinvolvedaholisticassessmentthatidentifiedthepotentialhazardsandriskstoproductqualityforallprodu

7、ctshandledinthefacilitytoensurethatappropriatecontrolswereinplacetomanufacturetheseproductssafely.Theassessmentsupportedthedevelopmentofaqualityriskmanagement(QRM)thataddressedthemanufactureofthefollowingproducts:XXX.对XXXXX生