撰写人：_日 期：_page1 /25东晓生物供应商审核报告DongXiao Biological SupplierAuditReportVendorCategory供应商类别：Quality&FoodSafetyRisk质量食品安全风险:AuditDate审核日期：ReportNo.审核报告编号:AuditConclusion审核结论OverallAuditSummary审核总结审核结果/OUTCOMEOFAUDITBriefIntroduction ofCompany企业基本情况VendorName供应商名称Product所供产品VendorCode 供应商编 号Address公司地址Contact Person 联络人Title职务PhoneNo.电话EmailAddress邮箱供应商基本信息/COMPANYOVERVIEW东晓生物供应商审核报告page2 /25姓名职务姓名职务参加审核人员/VENDORATTENDEES东晓生物审核人员/ROQUETTEAUDITORSAuditFindings审核发现审核发现/AuditFindingsListofSignificantHazard(s) Controlled/mitigatedby VendorSite 企业HACCP体系概述危害分析与关键控制点/HACCPpage3 /25o有违反食品安全标准或法规的潜在风险，须立即提出并限期整改。/ AdeficiencywhichrequiresanattentiontopreventapotentialFoodSafetyorregulatoryissuefromarising.o操作或文件方面有多处偏差。/Multipledeviationsobservedinexecutionordocumentation.o不符合食品安全的标准或法规。/FailuretomeetaFoodSafetyoraregulatorystandard.o体系缺失。/Failuretoorabsenceofsystemmanagement.o有面临食品安全问题的危险。/ArisktohaveaFoodSafetyfailureoraregulatoryissue. o关键控制点失控。/CCPsarenotundercontrol.o严重违反良好操作规范。/CriticalviolationofGMPs.o直接或潜在破坏罗盖特品牌形象。/FailurewhichputsormaypotentiallyputRoquettebrandintegrityatrisk.备注/PS：审核第一部分严重不符合项的数量将直接影响审核结果。/ Criticalauditfindingswoulddirectlylinktotheauditconclusion.不适用/N/A该条款不适用/Notauditableornotapplicable -不计算在内/Notcalculated严重不符合/CriticalAuditcriteriarequirementsarenotimplementedinthefacility,oracriticalfoodsafetyissueisobserved- 0分/0points完全达到/Conforms完全符合审核规范/Fullymeetstheauditcriteria-3分/3points轻微不符合/Minor基本符合或大部分符合审核规范,有轻微不符合项/Meetsmostormajorauditcriteriabutminorgapsarefound- 2分/2points;重大不符合/Major与审核规范要求有较大差距/Thereisamajordeviationfromtheauditcriteriarequirements-1分/1points评分规则/ScoringGuidelines:序号/ No.审核结论/AuditConclusion审核得分/Scoring审核发现/AuditFindings严重不符合项个数（审核第一部分）/CriticalfindingsinSectionI1通过审核/Passthesiteauditsuccessfully.8002有条件通过审核/Conditionallypassthesiteaudit.7023有条件通过审核，暂时保留其供货资格/Conditionallypassthesiteauditbutkeptastemporarysupplier.6034不通过审核/Failthesiteaudit.3审核结论定义/AssessmentSummary：东晓生物供应商审核报告page4 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁MasterSanitation Schedule: 主清洁计划主表1.1The facilityhasa documented MasterSanitation Schedule forall equipment,building,employee welfare,general areasand Utilities（Like overhead Cable tray,pipelines,lampshades,etc) . Appropriate standardsofhygiene and housekeeping are maintained atall times. 工厂有文件化的,清洁范围包括所有设备，建筑物，员工休息场所，普通区域和公共设 施(包括线槽，管道，灯罩等高空设施）在任何时候都能保持恰当的卫生和整洁水准.CriticalISanitation清洁1.2The MasterSanitation Schedule addressesproperperiodiccleaning frequenciesand cleaning requirements.在中规定了合适的清洁频率和清洁要求.N/A/ISanitation清洁Sanitation Procedures: 清洁程序1.3The proceduresinclude:chemicalsused and concentrations, time, temperature, frequency,etc. The cleaning proceduresaddressutensil and tool cleaning aswell asprocessing equipment.程序中包括所用化学品名，浓度，时间，温度及频率等细节。程序不仅包含设备的清洁， 也包含器具和工具的清洁。N/A/ISanitation清洁1.4CIP systemsare properlydocumented forbulksystemsorprocessing lines. A validation studyhas been conducted for the CIP systemand the record iskept.对于罐体和管道的CIP清洁系统, 有形成书面的管理文件.CIP系统也经过了验证试验,该验证也保留了纪录。Major1ISanitation清洁Sanitation Activities: 清洁活动1.5Cleaning recordsare signed and dated with verification signature ofsupervisoror teamleader. 清洁纪录有主管或领班的验证签名和日期。N/A/ISanitation清洁Verification of the Cleaning Program: 清洁计划的验证程序1.6Proceduresare in place and documented to validate and verify the effectivenessof the cleaning procedures. Ifcleaning isinsufficient,corrective actionsare in place and are documented. 有书面程序规定如何验证清洁程序的有效性。对超标的化验结果采取纠正措施并形成文件。Major1ISanitation清洁1.7After maintenance on equipment, the equipmentis re-inspected/re-cleaned prior to start-up.Evidence and awarenessexist to support thisactivity. 设备在启用前重新清洁和检查。要有证据和认知来支持这个行动。The facilityhascleaning and sanitation process for recycled containers.They mustbe effective for micro control. 有对容器回收使用的清洁消毒程序.对微生物控制是有效的。Major1ISanitation清洁Non-Food Chemical Program: 非食品级化学品程序1.8The facilityhasa written chemical control program to manage the use ofnon-food chemicals.Approved Chemical Listexistsand includesstorage and use locations. All non-food chemicals onsite are from the Approved Chemical List. 具有管理非食品化学品的书面