Title Page

  • Conducted on

  • Prepared by

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仓库 Warehouse

台账 Standing Book

  • 1. 是否有物料台账?Is there a material standing book?

  • 2. 台账登记和采购订单日报表中记录的实际到货时间/数量是否一致?检查台账和物料接收记录。至少检查5个物料信息。Is the actual arrival time/quantity recorded in the standing book consistent with the Procurement Daily Report? Check standing book and material receiving records. View at least 5 material information.

  • 3. 物料台账是否记录为最小单位?例如:吸塑纸单位为克。请用文字描述检查内容。Is the material standing book recorded as the minimum unit? For example: blister paper unit for grams. Please use words to describe check content.

  • 4. 物料台账是否有备份?备份频率?备份是否防丢失?请用文字描述备份频率和位置。Is the material standing book backed up? Backup frequency? Is the backup protected against loss? Please use words to describe backup frequency and location.

  • 5. 物料台账是否和领料单与货位卡是否合理?至少检查5个物料信息。Is the material standing book and material requisition and location card reasonable? View at least 5 material information.

标识 Label

  • 1. 仓库是否有明显的区域标识?例如:合格区,不合格区等。至少提供3张图片。Does the warehouse have obvious mark? For example: qualified area, unqualified area and so on. Provide at least 3 pictures.

  • 2. 仓库是否有货位卡?至少提供不同区域的5张图片。Does the warehouse have location cards? Provide at least 3 pictures in different areas.

  • 3. 仓库货位卡是否和台账清单一致?至少查看5个物料货位卡。Is the warehouse location card consistent with the standing book? View at least 5 material location cards.

  • 4. 物料外包装和最小包装是否有标识?例如:胶塞。Is the outside package and minimum package of material marked? e.g., seal.

  • 5. 货位卡的材料是否有合格和不合格判定?Is the material of the space card qualified or unqualified market?

  • 6. 共用同一货位卡的物料是否有物理隔离?例如隔离带或者绑带。Are materials sharing the same location card physically separated? For example, quarantine tape or bandages.

  • 7. 同一托盘上若有不同物料,是否都有货位卡?是否以最小单位标注?If there are different materials on the same pallet, are there location cards? Is it marked in the smallest unit?

  • 8. 关键物料是否有供应商的进货批号?Is there a supplier's batch number for critical materials?

  • 9. 是否有返仓库的物料?货位卡是否更新?Are there any materials returned to the warehouse? Is the location card updated?

  • 10. 待灭菌产品是否有物料标识?Does the product to be sterilized have material identification?

  • 11. 灭菌后的产品是否有物料标识?Does the sterilized product have material identification?

  • 12. 检验合格后的成品是否有标识或货位卡?Does the finished product have identification or location card after inspection?

存储 Store (请提供照片作为证据 Please provide photos as evidence)

  • 1. 物料包装是否完好?Is the material package in good condition?

  • 2. 原材料未放在露天场所?Raw materials not in the outdoor area without shield?

  • 3. 标签是否存储于专门区域? Does Labels store specific area?

  • 4. 所有原料是否都放在托盘上? Does all materials store in pallets?

  • 5. 不规则物料是否有缠绕膜?Is there a winding film for irregular materials?

  • 6. 成品外箱堆放高度是否合理?是否未超出托盘边缘?Is the height of finished goods reasonable? Does it not exceed the edge of the pallet?

  • 7. 物资摆放是否离地不小于10厘米,离顶不小于50厘米?Are materials placed not less than 10 cm from the ground and not less than 50 cm from the top?

  • 8. 物资摆放是否距离柱子、墙壁30-50厘米以上?Are materials placed at least 30-50 cm away from the pillars or wall?

  • 9. 是否有温湿度监控?Is the temperature and humidity monitored?

  • 10. 是否有足够的消防器材?Are there adequate fire fighting equipment?

  • 11. 仓库是否干净、无积水?是否无蚊蝇?Is the warehouse clean and free of water? Are there no flies?

  • 12. 仓库是否有鼠笼和挡板?并且挡板在无需搬运时被使用?Does the warehouse have cage and baffle? And the baffles are used when there is no need to carry?

  • 13. 诱虫灯是否使用?Are trap lamps used?

  • 14. 待灭菌和已灭菌产品是否放置到指定位置?Are pending-sterilized and sterilized products placed in designated locations?

  • 15. 是否有装箱前的柜内环境确认?是否有记录或拍照(装满1/3,2/3,3/3时拍照)?Is there any environment confirmation in the container before packing? Are there records or photos (Take the picture when fill 1/3, 2/3, and 3/3)?

  • 16. 集装箱是否成品摆放时,是否没有超出3层?Is the finished container placed within 3 layers?

  • 17. 是否有存放半年以上的物料?请具体描述。Are there materials stored for more than six months? Please describe in detail.

记录 Record

  • 1. 物料接收后,是否有进行请检?Is the material replied for check after receiving?

  • 2. 成品灭菌后,是否有进行请检?Is the finished product replied for inspection after sterilization?

  • 3. 是否保留所有物料的送货单?根据台账抽查3个物料。Keep delivery notes for all materials? Spot check 3 materials according to standing book.

  • 4. 是否有物料接收记录?Is there a material receiving record?

  • 5. 标签的领用发放是否单独形成记录?Is label issuance recorded separately?

  • 6. 是否保存领料单?Are material requisitions kept?

  • 7. 成品检验合格后是否有入库并形成记录?Are finished products stored and recorded after qualified inspection?

  • 8. 成品发货时是否有发货清单?Is there shipping records before finished product shipped?

  • 9. 货位卡是否进行整理并装订成册?Are location cards organized and bound?

  • 10. 是否有厂区卫生检查记录?Are there factory health inspection records?

  • 11. 是否有定期进行虫害鼠笼检查并形成记录?Are rodent cage inspections conducted regularly and documented?

  • 12. 是否有卫生清洁记录?Are there cleaning records?

  • 13. 是否有温湿度监控记录?Are temperature and humidity monitoring records recorded?

II. 灭菌 Sterilization

标识 Label

  • 1. 待灭菌产品是否有标识且经过核实接收?Is the product to be sterilized marked and verified for acceptance?

  • 2. 待灭菌产品外箱是否有灭菌指示贴?Is there sterilization instruction sticker on the outer box of the product to be sterilized?

  • 3. 生物指示剂是否按要求进行摆放并标识?Are biological indicators placed and labeled as required?

  • 4. 灭菌结束后,生物指示剂是否标记灭菌批号?After sterilization, is the biological indicator marked with sterilization lot number?

  • 5. 环氧乙烷气瓶是否进行标识?Are ethylene oxide gas cylinders labeled?

  • 6. 不同气体存储时是否有明显标志区分?Is there a marked distinction between different gases when stored?

防护 Protection

  • 1. 人员是否经过培训合格后上岗?请提供培训记录。Is the staff trained and qualified? Please provide training records.

  • 2. 是否有环氧乙烷灭菌操作作业指导书?Is there an ethylene oxide sterilization operation instruction?

  • 3. 灭菌设备是否进行点检与日常维护保养?Is the sterilization equipment inspected and maintained daily?

  • 4. 灭菌设备是否有定期维护保养计划并按照计划进行维护保养?Is there a regular maintenance plan for sterilization equipment and is it maintained according to the plan?

  • 5. 是否每一灭菌周期前对灭菌柜进行泄漏试验?Are leakage tests performed on the sterilization cabinet before each sterilization cycle?

  • 6. 现场是否有人员防护用品?人员进行灭菌操作时是否穿防护服戴口罩?Is there any personal protective equipment on site? Do personnel wear protective clothing and face masks during sterilization operation?

  • 7. 环氧乙烷气体钢瓶是否有固定支撑?Are ethylene oxide gas cylinders supported?

  • 8. 环氧乙烷气体存储室是不是由专人控制?其他人不可随意进出?Is the ethylene oxide gas storage room manned? No one else is allowed in or out?

  • 9. 环氧乙烷气瓶搬运时是否轻拿轻放?Are ethylene oxide cylinders handled with care?

  • 10. 不同气瓶是否有明显物理隔离?Is there significant physical isolation between different cylinders?

  • 11. 灭菌区域是否有防爆措施?防爆风扇,石墙等。Is the sterilization area explosion-proof? Explosion-proof fans, stone walls, etc.

  • 12. 是否有环氧乙烷废气处理装置?Is there an ethylene oxide exhaust gas treatment unit?

环境 Environment

  • 1. 灭菌柜中是否干净无异物?Is the sterilization cabinet clean and free of foreign matter?

  • 2. 是否有环氧乙烷报警器?Is there an ethylene oxide alarm?

  • 3. 解析库内是否干净无异物?Is the areation room clean and free of foreign matter?

  • 4. 环氧乙烷存储室是否干净清洁?Is the ethylene oxide storage room clean and tidy?

  • 存放气体区域是否通风、防晒、温度低于40℃?没有火源或易产生火花的电器?Is the gas storage area ventilated, sun-protected and the temperature below 40℃? No ignition or spark prone electrical appliances?

设备 Equipment

  • 1. 设备点检是否包括EO用量检查、自来水是否有水、供电系统是否正常等要求?Does the equipment spot check include EO consumption check, tap water availability, and power supply system normal?

  • 2. 设备点检中是否包括检查电控系统的接线端是否牢靠?以及实际维护保养记录。Does the equipment inspection include checking the reliability of electrical control system terminals? And actual maintenance records.

  • 3. 设备点检中是否要求每天检查一次循环水、真空、环氧乙烷、蒸汽、气化装置管路渗漏?以及实际维护保养记录。Is it required to check circulating water, vacuum, ethylene oxide, steam, and gasification plant pipeline leakage once a day during equipment spot inspection? And actual maintenance records.

  • 4. 设备定期维护保养是否要求每周对箱体内壁、门框进行清洁?以及实际维护保养记录。Regular equipment maintenance Is it required to clean the inner walls of containers and door frames every week? And actual maintenance records.

  • 5. 设备定期维护保养是否有每3个月更换一次加温系统的循环水?以及实际维护保养记录。Is the circulating water of the heating system replaced every 3 months? And actual maintenance records.

  • 6. 设备定期维护保养是否有每30个灭菌周期后检查和清洗系统和过滤器要求?以及实际维护保养记录。Is there a requirement to check and clean the system and filter after every 30 sterilization cycles for regular maintenance of equipment? And actual maintenance records.

  • 7. 设备定期维护保养是否有密封圈每半年更换一次?以及实际维护保养记录。Is there a sealing ring to be replaced every six months? And actual maintenance records.

  • 8. 灭菌设备上的仪表是否定期校准并在有效期内?Are gauges on sterilizing equipment calibrated regularly and up to date?

记录 Record

  • 1. 是否有设备点检和维护保养记录?Are there equipment spot inspection and maintenance records?

  • 2. 是否有设备使用记录?Are there equipment usage records?

  • 3. 灭菌工艺卡是否在有效期内?Is the sterilization process card within the expiry date?

  • 4. 是否形成灭菌批记录以及保存原始记录?Are sterilization batch records maintained and original records maintained?

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