注册产品药监局质量体系考核注意事项.doc

注册产品药监局质量体系考核注意事项1、在设计过程中是否进行了风险分析。Product D FMEA for product risk analysis2、是否建立并保存了该产品的全部技术规范和应用的技术文件（包括产品技术文件清单）。Product specification, work instruction, BOM, IFU3、是否保存了试产注册后该产品设计修改的记录。Product change record; 4、是否建立了申请准产注册产品主要采购内容清单，并确定了合格分承包方。Buy material list, buy specification, and qualify supply vendor procedure;5、该产品的采购资料是否清楚、明确、齐全。Material buy specification control and sign off with supply vendor6、是否确定了申请准产注册产品的关键过程和特殊过程（工序）并制定了相应的控制文件或作业指导书。Key process and special process sop, process windows, control plan7、无菌医疗器械是否按照无菌医疗器械生产管理规范组织生产。-无菌产品要在洁净室生产。洁净室要每年委外检测。要根据YY0033进行环境监控。Clean room control, and clean room check by certified centor8、该产品所需的设备、工装、检验仪表是否具备，并能满足产品制造过程的要求。Equipment and assembly process capability and capacity9、参加该产品的施工制造人员是否具备相应资格或经过针对性的培训。Operator training system and training record 10、是否确定了该产品过程检验的内容、规程和记录。Product inspection items, procedure and record11、是否对该产品要求的作业环境，产品清洁作出规定。Product line clean room condition, product FM issue and visual inspection requirement12、否建立了用于该产品安装、查验的技术资料和接受准则。Product assembly machine or electronics medical device install, inspection technicial files and acceptance criteria;13、是否规定了过程控制中应形成的记录。Lot number control and device record history control14、是否对该产品的可追溯性范围和程度进行了确定。（材料、元件、过程和去向）。Product traceability control and scope(Raw material, components, process and using area)15、现场能否看到产品标识（包括最终产品的标签）及检验试验状态的标识。-生产现场产品标识要清晰。检验状态要清晰（如待检、检测合格、不合格）Label identify product status(WIP control, good parts, NG parts identify) and inspection status identify; product line should have clear area or mark to clear product status, inspection status(For examples: wait for inspection, pass, NG)16、是否进行进货检验和验证。In coming inspection validation; or incoming inspection sop17、最终产品的检验试验是否覆盖了该产品的技术标准全部出厂检验项目.QA out going inspection items should cover all product STD specification, if can not meet, should have outsourcing inspection follow fix time;18、上述检验试验记录及最近一次型式试验报告是否保存-需要每年做型式检测All inspection record should be kept, and last full function inspection in SFDA qualify center should be kept, and every year should do full function inspection;19、企业有无相应的测试设备。Plant should have test equipment and qualify QC,QA20、是否按一定程序处理顾客投诉并保留记录.Should have quality Engineer to handle customer complain, and have a control procedure to control it21、仓库摆放要账卡物一致，同一产品，不能摆放在多处。危险品要另仓存放Ware house in and out QTY should be matched, first in and first out control, different product should be put different area, and danger raw material should be kept in safety area,22、静化车间内，物料、产品摆放整齐，标识清晰。不生产的设备要挂停用牌。Clean room material, wip and products should be put clear, clear mark, no produce machine should be marked clearly;23、静化车间要注意物流通道、人流通道的使用。清洁房清洁设备摆放。洗手消毒液要注明配制日期、有效期。压差要正常，回风要足。出风口要出风。风帘门要开。空调机房内要保持干净无积水。Clean room should have material road, people road, clean room clean tool room, clean hands should control using time, air pressure should be ok, back air pressure should be ok, air condition s