Estee Lauder验厂咨询-深度解读品质审核范围之涵盖多环节的质量把控细则

QUALITY AUDIT SCOPE:  质量审核范围
A.  GENERAL REQUIREMENTS 一般要求
1)  Provide a written document  statement regarding the corporate quality policy of the factory- Senior management of the company must each keep a copy.
2)  This policy is to be distributed and adhered to by all employees.- Proof that the employees received this document and understand quality procedures.
3)  Provide training program at the facility in GMP's, equipment operation and safety.
对于GMP,必须有类似的培训,已经设备的操作安全等.GMP:Good Manufacturing Practice的缩写。通常指「药品生产质量管理规范」。
4)  Keep training records up-to-date.- M ake sure all training is recorded by training done, staff members trained, etc.应保存培训的资料,确保被培训者也有做记录.
5)  Provide sufficient Engineering, Production, Quality Assurance and Customer Service support to meet EL requirements/needs.为了达到EL的要求,工程,生产,品管,客服都能提供足够的支持以及配合.
6)  Continuous process improvement program- Maybe weekly or monthly meetings to evaluate processes and plan how to improve- a formal meeting.不断的改善,可以定期召开正式的周会或月会来评估我们现在的生产以及将怎么样更好的改善.
7)  Set up internal audit program- have someone in charge of auditing in the factory.建立内在审核制度,有专人负责审核.
8)  Provide procedures for addressing subcontractor quality levels- If they use any subcontractors- how do they make sure they follow all the same rules.有制度对于外发商,来确认他们遵守这些规定.
9)  Facility must be in good repair and clean.  Make sure everything is very clean & organized and there are no broken equipment.设备必须保养的好,确认所有机器干净与良好,而且没有坏的设备.
10)  Conduct periodic extermination/pest control.- Keep records of any extermination- or how they destroy any bugs 有定期的防虫检查,并有记录,怎么去控制那些害虫.
11)  Provide proper security to prevent unauthorized entry.- Have gates with guards, ID badges for everyone that are always worn, 有安全的措施防止未经过允许的人进入,有保安守卫,有每个人都要佩带的一些证件.

B.  ORDER PROCESSING & DOCUMENT CONTROL 订单管理和处理
1)  Customer approved specs, drawing, standards and artwork is to be incorporated into the firm's internal documentation.- For EVERY order, there is a final file that has the FINAL specs for that item.  If there are any changes, the old specs must have a big note on them that they are not current- refer to new specs- OR any method that everyone follows to make sure that all the info is never confused when there are changes.客户确认过的样板,文档,标准需要一起建档保存,对每个定单都应该这样,对于最后确定的文档,都应该有相关的记录,如果有改动的话,必须要有明确的注明,那些文档是旧的,以区别于新的文档.或者每个人都可以有自己的方法去确保所有的信息不给搞混当有新旧文档的时候.
2)  Provide assurance that current editions are utilized in the manufacturing process (double checks).  Have an area at each production line that shows EXACTLY the finished product and standards accepted 要确认正确的版本流通在生产线上,要仔细确认,并在制作的每条生产线上显示正确的样板和客户的标准.
3)  Utilize customer testing procedures properly.- Have a list of tests that can be done based on customers requirements- how do they do drop tests, rubbing tests, color tests, etc.正确的运用检测程序,有根据客户的需要做的测试的清单:如跌落实验,颜色测试,磨损测试等.
4)  Provide procedure to follow in when notifying the Customer of any physical changes in a component or manufacturing process of that component.- Have a rule written down that explains what to do if there are changes in the item .  For example- when variances are found, production will immediately stop and the  variances must be shown to the customer and approved in writing before proceeding. 在通知客户需要做修改时必须有相关的程序文件通知到客户,写明为什么要做这些修改,如:如果生产中出现问题,应该马上停止,这些异常需马上呈现给客户,需得到客户的确认后才可以继续生产.
5)  For new product launches, provide a system to develop testing procedures ensuring quality components. Describe how the factory tests new materials and inks or other processes if it is something new to them.对于新产品的开发,必须有明确的程序指导测试,以保证新产品的质量,要记录工厂对于新材料,新油墨以及其他工艺是怎么进行测试的.
6)  Provide a system to investigate and assign corrective action to customer complaints and / or customer rejects.有制度对于客户的投诉和不良品需要正确的处理.

C.  PRODUCTION生产
1)  Manufacturing environment must be acceptable for items produced.生产环境必须适宜于在生产的产品.
2)  Manufacturing operations must be orderly in flow and organization.操作必须有序有指导的进行.
3)  Use specific operator apparel (hair-nets, masks, gloves, etc.) appropriately.有需要特别配套的装备,帽子,手套,口罩等.
4)  Keep equipment cleaning and maintenance logs up-to-date.有随时保养好仪器并做好记录.
5)  Properly mark and label all component molds, cutting dies, printing plates.对于所有印刷版,刀模等必须有正确和明确的标记.
6)  Check all component molds, cutting dies, printing plates again the approved blueprint/artwork prior to production run.在生产前,所有的刀模,印刷版是否进行了确认.
7)  Provide procedure assuring only the correct die, mold, or printing plate is pulled from storage and released to manufacturing.是否有完整的程序规定只有正确的刀模/印刷版等才可以直接从储存室中取出用于生产？
8)  Is this check documented.以上检查是否有记录?
9)  Document line clearances between different labeling or packaging operations before they begin.在生产之前,对于不同的标签或包装方式的是否进行了明确。
10)  Conduct first article inspection prior to production start.在生产前是否对所有资料进行首次检查.
11)  Supply current color standards and customer approved defect range boards readily for the manufacturing employees.是否有对线上员工明确了客户的限度样板和颜色标准.
12)  Items being manufactured must be identifiable throughout the operation or process.所有生产工序相关项目是否进行了识别(生产工序单).
13)  Provide adequate segregation to assure mixing of items does not occur.生产线线上所有物料是否进行了明确标识,以免混淆.
14)  Document any deviations from the normal manufacturing procedures.对于正常的生产过程中出现的异常是否有异常处理报告.
15)  Provide procedures (S.O.P.'s) for handling of rework.对于返工的东西是否提供了SOP.
16)  Place waste materials in containers clearly marked as "waste materials only".废弃的东西装在特定的容器里,并进行相关标识说明.
17)  Place rejected items off-line and segregated items away from the "good" material.废弃材料与良品是否进行了隔离.
18)  If in-process materials are rejected, indicate reason on the container and record on the line sheets.如果生产中的材料不合格,一定要在包装上注明原因,并做好相关记录.
19)  Retain manufacturing records and production samples for an adequate period of time and keep them readily available.一定要保存好生产记录和生产的样板等,保存至足够的时间,而且需要时可以随时取用.
20)  Provide procedure for revision or destruction if a cutting die, component mold, or printing plate is defective对于刀模,文档,印刷版的更正或毁坏必须有正规的制度.
21)  Is this check documented.以上检查是否有记录?
22)  Utilize Statistical Process Control (SPC) where appropriate.在需要的地方有统计控制管理.
23)  Determine process capability for all quality characteristics of components being manufactured at the facility.是否对产品所有工序质量特性的能力进行了界定?
24)  Utilize any other process controls or process improvement tools where appropriate in the manufacturing area - please specify what they are.在生产区域是否有用到品质工具来改善工艺,如果有,请说明是哪些.(如8D/QCC)

D.  WAREHOUSING仓库管理
1)  Provide acceptable warehousing environment for product storage.能提供保存好产品的环境.
2)  Keep shipping / receiving / staging area clean, dry.保持出货区,收货区,储存区的干净整洁.
3)  Store all items off of the floor on pallets.所有产品都保存在卡板上.
4)  Identify all pallet locations within a stock locator system.确认所有的卡板有管理的系统.
5)  Properly identify incoming items (raws, components and WIP).所有入库的物料或产品是否有进行标识?
6)  Segregate approved items from items awaiting disposition.良品与呆滞品是否有进行分隔.
7)  Place rejected items in a quarantine area and maintain appropriate records.对于不良品或退货品是否在一个单独的隔离区,而且保持有相关记录.
8)  Properly label, identify and segregate final, approved product in the shipping / storage area.出货区的产品是否按类别进行了存放与标识.
9)  Palletize skids according to customer specs.根据客户的要求制定相关的卡板.
10)  Keep records describing shipment amounts and arrival dates.有专门的记录入仓时间和数量.
11)  Verify shipping label bar codes with a scanner.所出的货物的条形码是否有通过扫描?

品质管理
1)  If warranted, Quality Assurance Department  should have independence necessary to override Manufacturing decisions.是否有相关授权,品管部门有权停止生产.
2)  Provide sufficient personnel, testing and measuring equipment in Quality Assurance department to assure product quality.品管部门是否有足够的人员,设备,测试去保证产品的质量?
3)  Maintain system in proper working order to assure that gauges, tools and testing equipment .有正确的工作制度去确保工具,测量仪,设备等符合运作要求(维护保养).
4)  Implement a system to assure that gauges, tools and testing equipment are calibrated on a periodic basic.检验仪器及检测设备是否进行了仪器校验?
5)  Provide in-process inspection and test procedures that equal or surpass Estee Lauder requirements and AQL levels.是否有在线检验与测试以保证产品符合EL的要求并达到质量水平的.
6)  Are these tests / inspections performed and documented?.是否保留了相关记录及有相关检验标准?
7)  Investigate and review non-conformances found during an in-process inspection with manufacturing for corrective action.如果生产过程中检验出现不合格品是否进行评审并采取了纠正预防措施.
8)  Quality Assurance must review production records as part of the release criteria.检验人员是否把评估生产相关记录作为检验放行标准的一部分?
9)  Implement procedures for final product sampling and inspection.最终检验是否有相关程序?
10)  Record final inspection or audit results.是否保留了最终检验记录?
11)  Implement procedure for inspection of completed boxes for content prior to sealing/taping and release to shipping area.是否有出货检验的程序,检验完放在出货区.
12)  Involve QA in new project launches.在新项目上有QA的参与.

PART II COMMODITY
高水平评估Indicate the highest level evaluated:
1)  Level of defect range boards used 限度样板的使用管理
2)  Conformance of products with EL requirements during production在生产中达到EL的要求.
3)  Conformance of parts during production to defect range boards being used.生产产品符合限制样板的要求.
4)  Scrap rates during production 报废率统计.
5)  Repeatability of set ups in production.生产可重复性(一致性).
6)  Prevention of damage to products in production.生产过程中产品防护.
7)  Prevention of contamination of products in production.保证生产过程中产品不受污染.
8)  Conformance of products to EL requirements goods approved by the supplier.供应商必须保证生产的产品满足EL的要求.
9)  Conformance of products approved by the supplier to defect range boards being used.供应商提供的产品符合限度样板的要求.
10)  Prevention of damage to approved products during handling, storage and inspection在生产,运输,储存,检查的过程中产品防护.
11)  Prevention of contamination of approved products during handling, storage and inspection在生产,运输,储存,检查的过程中不得交叉污染.