食品单位供应商审核报告

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化学品控制计划。具有注明储藏地点和使用场所的核准化学品清单。有 一个受控的化学品清单。所有在现场使用的化学品都来源这个清单中。（工业级的清洁剂不可以应用 于生产区域清洁。）Major1ISanitation清洁1.9All non-food chemicalsare stored in locations to preventunauthorized entryand are separated bybarrieras to preventcontamination ofproductsand other materials. Access to chemical storage areasislimited and controlled. (i.e.locked storage room). 所有非食品化学品储藏在规定的场所，预防不经授权的进入，并由物理屏障以预防污染。化学品储藏 区的进出是有限制的，受控的。Confirms3东晓生物供应商审核报告东晓生物供应商审核报告告page5 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁1.10Chemicalsare stored in properlylabeled containers,and any transfercontainersare also properly labeled with the contents (chemical name).化学品容器及任何转换容器都恰当地标有其内容。ConfirmsISanitation清洁MSDSCommunication: MSDS 物料安全数据单的交 流1.11MSDS sheetsare available and easily retrievable forall non-food chemicals. Employeesare aware of the location of the MSDS sheets. 所有非食品化学品都具有MSDS。所有非食品化学品的MSDS可易于得取。员工知道MSDS 的放置地点。MinorIHACCP 危害分析及关键控制点2.1A formal multidisciplinaryHACCP teamisin place to modify,implementand maintain the HACCPplan foreach productorprocess.HACCP小组人员来自不同的部门/功能。Minor2IHACCP 危害分析及关键控制点2.2The HACCP teamleaderand membershave received HACCP training. Recordsare available and theirHACCP knowledge isconfirmed.HACCP组长和组员都得到 HACCP 的培训纪录和知识。有保持记录并对他们的HACCP知识进行确认。ConfirmsIHACCP 危害分析及关键控制点2.3The process flow diagramsisavailable. Theyare accurate and current. 有准确和现行的工艺流程图。Including：Flow chartand the practical processisconsistent. 流程图和实际流程一致。The auxiliary for food directcontact/indirectcontact, AIDS isspecified. 与产品直接/间接接触的助剂需注明。Major1IHACCP 危害分析及关键控制点2.4The facilityuseshazard analysis to identifyall necessaryCCPs (biological,chemical,physical hazards). Hazard analysisconsidersboth severityand likelihood of the hazard occurrence. 识别所有必要的CCPs，生物性，化学性和物理性的危害，考虑危害发生的严重性和可能性两者。Confirms3IHACCP 危害分析及关键控制点2.5The facilityhasidentified the raw materialsand processeswhich are easilychemical contaminated, such aschemical residue,pesticide residue, melamine,heavy metals,and/or mycotoxins. 容易产生物理污染的原料和生产过程已被识别，如金属、玻璃、硬塑品、木屑、纸张等。Major1IHACCP 危害分析及关键控制点2.6The facilityhasidentified the raw materialsand processeswhich are easilychemical contaminated, such asheavy metals.容易产生化学污染的原料和生产过程已被识别，如重金属。Confirms3IHACCP 危害分析及关键控制点2.7The facilityhasidentified the raw materialsand processes which are micro sensitive。 易受微生物污染的原料和过程应被识别。Confirms3IHACCP 危害分析及关键控制点2.8Critical limits foreach CCP are validated with documented evidence /justification. 每个CCP的关键控制限度都有成文的证据/理由的确认。Confirms3page6 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIHACCP 危害分析及关键控制点2.9ListCCPs. Theyare appropriate to the processunder the audit. 列出所有的CCP点。并保证被审的CCPs对于生产过程是恰当的。Confirms3IHACCP 危害分析及关键控制点2.10Monitoring procedures forall CCPsare adequate. Theyare performed and recorded at required frequencies. 所有CCP都有充分的监控程序。监控在规定的频率得到执行和记录。MajorCCP2为烘干工序,监控对象为产品与热风的混合温度60,监控频率为每小时一次,但查当天现场实际的监探频率 为1.5小时到2小时不等.IHACCP 危害分析及关键控制点2.11Documented corrective action procedure isin place and followed when Critical Limitsare not met. Evidencesand awarenessofcorrective action show effective implementation of the procedure. 有书面的纠正措施程序。当关键控制限度不能达到时，此程序得到执行。纠正措施的证据和认识确能 表现此程序的有效实施。Major1IHACCP 危害分析及关键控制点2.12The HACCP plan is reviewed atleastyearlyand when changesare made to the processand the review isdocumented. The HACCP plan review iseffective. HACCP方案每年至少评审一次，并当生产过程有变化时。评审得以纪录并有效。Major1IHACCP 危害分析及关键控制点2.13The operatorsand supervisorsdemonstrate knowledge ofCCPsand required actions. 操作工和其主管能体现对CCP的知识认知和了解所要求的措施。Critical0IHACCP 危害分析及关键控制点2.14Employees responsible for monitoring CCPshave received documented HACCP training. 负责监控CCP的员工得到HACCP的培训并有记录。Major1IAllergencontrol过敏源控制Allergen Policiesand Procedures: 过敏源的政策和程序3.1The facilityhasevaluated raw materials,ingredients,processing aids,and packaging materialsetc.forallergens/sensitizers. The allergen/sensitizerevaluation evidence isavailable. List the allergens/sensitizersonsite. 工厂经过对原材料，配料，生产辅料，和包装材料等评价，以作过敏源/致敏化学品的确认，不管工厂 有无过敏源。评估的证据要保持。如有，请列出所有的在现场的过敏原清单。N/A/IAllergencontrol过敏源控制3.2Allergensand sensitizing agentsare clearlyidentified and segregated fromnon-allergenic ingredientswhen applicable. 适用时，过敏源和致敏化学品有明确的标记并与非过敏材料分开存放，不同的过敏源也要分开存放。N/A/IAllergencontrol过敏源控制3.3Proceduresare in place and followed to adequatelyprevent the crosscontamination ofnon- allergenicingredientswith allergeniccomponents. 要严格按照制订的程序执行保证过敏原不会污染非过敏原的配料。N/A/IAllergencontrol过敏源控制3.4Allergen containing productsare scheduled atspecific timesand using dedicated equipmentand utensilswith designated staff to minimize crosscontamination. 在生产计划时，含过敏源产品的生产安排在特定的时间，使用专一的设备，器具，和指定的人员。N/A/东晓生物供应商审核报告page7 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIAllergencontrol过敏源控制3.5Cleaning utensilsand tools for the production ofallergen containing productsare clearlyidentifiedand isolated from the production ofnon-allergenicingredients. 用于含过敏源产品生产的清洁器具和工具有明确标记，并与用于不含过敏源产品生产的清洁器具和工 具分开存放。N/A/IAllergencontrol过敏源控制3.6The allergen control programspecifieswhere and how reworkproductsare handled and re- introduced to the production process. 过敏源控制程序注明返工产品在哪里并如何处置，并如何引入生产过程。N/A/IAllergencontrol过敏源控制3.7Cleaning proceduresand allergen verification kitsor toolsare established forproductchangeovers. Recordsare kept.已建立更换生产产品时的清洁程序和过敏源测试套，并保持纪录。N/A/IContaminationPrevention预防污染Foreign MaterialControl (filters/strainers/sieve s): 外来物质的控制（滤 器/滤网/筛网）4.1Foreign matterprevention devices (filters,strainers,sieves,etc.)are in place and routinely inspected,cleaned,and in good condition. Recordsare kept. 生产线装有过滤设备。过滤设备定期地得到检查，清洁并保持在完好的状态。List the filters/sieveslocation,size and inspection frequency. 列出过滤网/筛网的位置、大小和检查频率。Confirms3IContaminationPrevention预防污染4.2Proceduresare in place to review productsafetyin the event thata foreign matterprevention device(filters,strainers,sieves,etc.)isinspected and found damaged. Recordsdemonstrate compliance to requirements.已建立当发现过滤设备损坏时对产品安全所评审的程序，并保持记录。Confirms3IContaminationPrevention预防污染Metal Detector/X-ray: 金属探测器/X光探测 器4.3Metal detectorsand/orX-ray machinesare on all productlinesifnotlimited byproduct type.如果不受产品的局限，他们应被安装在生产线上。Do Metal Detectorsbe installed on all productlines?是否在所有生产线都有安装金属探测器？ List Metal Detectorslocation,sensitivityand monitoring frequency. 列出金属探测器的位置、灵敏度和监控频率。灵敏度要求Fe 1.0mm,Non-Fe 1.5 mm,S/S 1.5mmMinor2IContaminationPrevention预防污染4.4Written proceduresand guidelinesexistand are followed forcompliance and verification of metal detectors/X-ray machines. Checksare recorded and reviewed with detailsofanycorrective action taken. List the type and size of testing piecesused. 有书面的金属探测器/X光探测器操作使用程序。此程序已得到实施。对金属探测器/X光探测器的检查 得到纪录和复查，并包含任何已采纳的纠正措施的细节。列出采用的测试模块的种类和相应的尺寸。Confirms3,IContaminationPrevention预防污染4.5Operatorsare trained on metal detection/X-rayproceduresand requirements. 操作工得到程序和要求的培训。Minor2东晓生物供应商审核报告page8 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPrevention预防污染4.6Proceduresand guidelinesare in place in the eventofa metal detectororother foreign material detectoris found to be non-operational. 已建立当发现金属探测器/X光探测器不正常工作时的纠正措施程序。The use of monitoring and recording:-监控方法和计划- monitoring method and program-剔除产品的控制和处理-Control and eliminate product-异物分类和纠正行动（短期和长期）- foreign material classification and corrective action (short-termand long-term)Major1IContaminationPrevention预防污染Wood:木制品4.7No wood itemsin areaswhere food orproductsare exposed. Ifwood itemsare unavoidable,a wood control and inspection procedure isin place to prevent foreign material contamination.High clean zone production site doesnotallow the use ofwood productssuch aswood palletsetc. 在食品或产品暴露区域，没有木质材料或器具。如木质材料或器具不可避免，已建立了木制品的控制 和检查程序。Confirms3IContaminationPrevention预防污染Glass&BrittlePlastic:玻璃和硬塑料4.8The documented glasscontrol proceduresinclude instructions forline stoppage,segregation of suspectproduct,cleaning and re-inspection ofequipmentprior to start-up. 书面的玻璃控制程序包括玻璃/硬塑料破碎处理的指导（停止生产线，分隔，清洁，和重新检验）。Confirms3IContaminationPrevention预防污染4.9All glassand brittle plasticitemsin the areaswith exposed food are inspected regularlyand records are keptwith corrective actions. 所有在食品暴露区域的玻璃和硬塑料物品得到定期检查，并保持包含纠正措施的纪录。Critical0IContaminationPrevention预防污染4.10Overhead light fixturesare covered with shatterproofplasticorcovered with sleeves. 灯具有防暴塑料罩或套管的遮盖。Confirms3东晓生物供应商审核报告东晓生物供应商审核报告page9 /25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPrevention预防污染OperationalInspection:过程检查4.11Are equipment,utensilsand containerswell maintained? There isno breaks,losing corner,etc. 设备、器具和容器是否保养良好？无破裂、缺角等？焊接设备是否满焊并打磨平整？Major1IContaminationPrevention预防污染4.12Pre-operational checksinclude a review of metal to metal contactpoints,screws,nutsand bolts, and equipmentwear forpossible contamination risk to the product. The checkisimplemented. 开工前检查包括评估金属和金属的接触点，螺母，螺丝钉，螺栓，设备磨损可能会对产品引起的污染。这些检查必须有效实施。Major1IContaminationPrevention预防污染4.13Operational checksinclude control of risksinherentin the process (knifes,nails,devices, paper/plastic/dust,etc.) 过程检查必须包括控制过程中内在的风险（刀具，钉子，设备，纸片，塑料和灰尘等）。Major1IContaminationPrevention预防污染Lubricants:润滑油4.14Lubricantsand processaids thatused in oradjacent to productcontactareasare foodgrade.用于接近或与产品接触区域的润滑油和生产辅剂是食品级的。-靠近食品或食品接触面的机械设备都必须使用食品级的润滑油，（经过轴承后的润滑油处理） Lubricating oil near the food or food contactsurfacesofequipment mustuse food grade, (treatment after the bearing lubricating oil )-不同润滑油的标准，采购，储存和使用控制-procurementstandards,differentlubricating oil,storage and use ofcontrol-添加润滑油的SOP和培训(添加量，方法，频率和异常处理）Add lubricating oil SOP and training (content, methods, frequencyand exception handling)-润滑油添加记录和检查Lubricating oil adding recordsand inspection-添加润滑油的设备检查频率，和处理要求。Equipmentinspection frequencyadd lubricating oil,and processing requirements.Major1IContaminationPrevention预防污染4.15Productcontactcompressed airis filtered. Food grade lubricantoil isused for the aircompressor forproductcontactcompressed air. 与产品接触的压缩空气经过过滤。用于与产品接触压缩空气的空气压缩机润滑油是食品级的。N/A/IContaminationPrevention预防污染Micro:微生物4.16If the facilityDoesnthave micro killing step in process, they musthave othercontrols to prevent finished products from micro contamination. 如果无过程灭菌措施，必须对成品有微生物污染的控制。Confirms3IContaminationPrevention预防污染CrossContamination Prevention: 交叉污染的预防4.17Raw/pre-processed areashave a negative pressure to adjacentareas. Clean areasshould have a positive pressure to the exterior. Take a strip ofpaperand checkairflow near openings.前加工区对下一相邻区有负压。洁净区对外部有正压。Minor2IContaminationPrevention预防污染4.18Access to the production areas (especially the filling/packaging areaswhere food isexposed)is restricted. Where applicable,change ofclothes,shoes,hand washing and disinfecting are practiced.进入生产区是有限制的。适用时，更衣，换鞋，洗手和消毒得到实施。Confirms3IContaminationPrevention预防污染4.19The productcontactairorcompressed air filtered.与产品接触的空气或压缩空气是经过过滤的。 List the filt