Vendor Factory Evaluation Mandatory and Production Sector Details

　　Document Control Is there a procedure in place that defines how documentation iscontrolled?

　　工厂是否有如何控制内部文件的程序?

　　The factory must have at least one written procedure that describes the process and activities theyperform to assure documentation is controlled. These controls may include, but not limited torevision control, authorizing & approving, control of obsolete documents, retention periods, wheredocuments are located, etc.

　　核实工厂是否有至少一份书面程序文件，其上规定相关的操作流程文件和业务文件是受控的。这些控制程序包括但不仅限于：文件的更新，授权和确认，过期文件的控制，存放保管年限，存放位置。

　　Document Control Is there a "Master List" of controlled documents? 工厂是否有受控文件的总表?

　　The document control system is to provide a means of knowing what documents the factory has andtheir latest revision level. The factory must have a master list or some other means of controllingtheir documentation.

　　核实工厂的受控文件的总表，其上应该列明了工厂有哪些受控文件和受控文件的最新版本。

　　Document Control Are documents in use the current version and are they authorizedand dated?

　　工厂正在使用的文件是最新版本及被授权的版本吗?

　　During the document review (Examples: QA procedures, Production work instructions, SOP's, etc.)and during the factory floor walk thru, select or identify a sampling of documents and then comparetheir revision level with the master list or whatever means the factory is using to track theirdocuments. The majority of the documents sampled are to have the same revision as indicated bythe document control system and they are to have evidence of authorization such as a signature anda date of issuance.

　　核对工厂的文件时(例如：质检流程，产品生产指导，标准操作程序文件，等等)，先随机选择若干个要抽查的文件名称，然后在巡视车间时，根据受控文件总表或者工厂使用的其它跟踪文件，来对比抽查的文件是否使用了最新的被授权的版本。工厂的内部文件应显示这些文件在发放前是被授权的，如签名，发放日期等授权证据。

　　Document Control Is there a procedure in place to ensure obsolete documentation isremoved from use?

　　工厂是否有避免使用过期或废弃文件的程序?

　　Review and ensure the document control procedure or procedures include a description of theprocess the factory uses to remove obsolete documentation from use. Look for evidence that it is核对工厂的文件控制程序，是否描述了如何将过期文件移除，避免错误使用的程序。工厂提供相应的正在使用的文件加以证实。

　　Document Control Is the documentation readily accessible by all relevant staff at alltimes?

　　工厂内部的文件能够被所有相关员工随时便利地获取吗?

　　Interview and observe to confirm factory workers have reasonable access to the documents neededto do their jobs.

　　通过面谈和观察来证实相关员工能合理地获取他们工作需要的文件。

　　Document Control Is there a written procedure that defines how quality records arestored, protected, and disposed of as well as a defined retentionperiod?

　　工厂是否有程序文件规定了质量记录如何存放，保管，存档期限和如何销毁?

　　Review documented procedure on how the factory maintains quality records. The Procedure mustindicate the retention period is at minimum 5 years after production has ended. Record review mustvalidate records have been maintained for a minimum of 5 years after production has ended; ormaintained since the creation of the Document Retention Procedure.

　　核对工厂的程序文件，了解工厂如何保存质量记录。程序文件应规定，自生产结束后，相关的质量记录必须被保存至少5年。工厂出具相关的文件存档来证实文件的存档期达到5年;或者自新的存档期限生效后，文件保存至今，虽少于5年，但将按照规定执行。

　　Quality Management Does the QA (Quality Assurance) or QC (Quality Control)department operate separately from the Production department?

　　工厂的质检部门是否隶属于生产部门?

　　Review an Organizational Chart to see where the QA or QC Department reports. If they report toGeneral Manager, President, etc. score a YES. If they report to anybody in the ProductionDepartment, score is a NO. If organizational chart is not available, interview factory QA/QCleadership.

　　核对工厂的组织架构图，如果质检部门隶属于总经?或总裁，选择YES，如果质检部门隶属于生产部，选择NO。

　　如果没有组织架构图，当面咨询工厂的质检人员。

　　Quality Management Does the quality department have coverage during all shifts?

　　工厂的每个生产班次都有质检部门人员同时工作吗?

　　Review random documentation of shift schedules. If shift schedule is not available, interviewfactory QA/QC leadership. For every production shift, there must be QC coverage.

　　随机核对工厂的打卡记录加以佐证。如果没有打卡记录。当面咨询质检管理人员。每一个生产班次都必须有质检人员。

　　Quality Management Are measureable quality goals identified and actual performanceresults collected?

　　工厂是否有可衡量的质量目标并收集实际的执行结果?

　　Review random documentation of quality goals performance results. Documentation must includegoals and pass rate per product category. Must be available and complete.

　　随机核对工厂的质量目标及执行结果。文件、记录必须包括每种产品的质量目标和通过率。记录完整的文件应可以随时提供以便于查阅。

　　Quality Management Are documented, ongoing Quality Control (QC) meetings held at thefactory in which Production is represented?

　　工厂是否举行持续的、生产部门一同参加的质量控制会议，是否有会议记录?

　　The factory must have, at a minimum, weekly QC meetings to discuss production issues, defectissues, etc. Documentation must include production issues and corrective action taken. Aproduction manager or supervisor is to attend the QC Meetings. Must see evidence of the above inthe documented meeting notes.

　　核实工厂是否至少每周举行一次质量会议，以便讨论生产中的问题,，产品疵点等。会议记录必须包括生产中遇到的问题和整改措施。生产经理或生产主管应该出席质量会议。在质量会议记录中必须显示上述内容及出席人员名单。

　　Quality Management Do the ongoing QC meetings demonstrate measureable, continuousimprovement?

　　工厂的持续质量会议记录，是否显示工厂的产品质量水平是可以衡量的、并且得到了持续性的改进?

　　Validate by reviewing records, data collection, and interviewing leadership. Verify there ismeasureable continuous improvement.

　　核对工厂的质量会议记录，相关数据，同管理层面谈。核实质量方面是否有可衡量的持续改进。

　　Quality Management Are daily or weekly quality goals and actual performance resultsposted on the factory floor?

　　每天或每周质量目标和实际质量执行结果是否张贴在生产现场?

　　While walking the production floor, look for posted quality goals and performance results.

　　在车间巡视的时候，核实工厂的质量目标和实际质检结果是否在生产车间明示。

　　Supplier Management Is there an inventory control system with incoming/outgoingmaterials monitored and documented (location, quantity, etc)?

　　工厂是否有库存管理系统来控制和记录进出物料(存放地点，数量，)Review documentation to verify that all incoming / outgoing materials are monitored by aninventory control system. Verify location, material type and quantity matches inventory records.

　　核对工厂的库存管理文件和记录，核实所有进出物料是否被库存管理系统有效监控。核对存放地，物料类型和数量与库存记录是否匹配。

　　Supplier Management Does the factory have a documented supplier approval procedure,including a list of approved suppliers for products, materials andservices impacting product safety, legality, or quality?

　　工厂是否有供应商审核程序，包括被核可的供货商清单，被认可的产品、物料和服务类别，被核可的供货商所提供产品，应符合安全、法律法规及质量的要求?

　　Review documentation to ensure the site has:

　　- A documented supplier approval procedure- A list of approved suppliers for products, materials and services impacting product safety, legalityor qualityNot Applicable will apply if factory does not manufacture a finished product.

　　核对工厂的供货商审核程序文件是否包含：

　　—确认工厂有供应商审核程序。

　　—被核可的供货商生产的产品清单，这些产品、物料符合安全、法律法规及质量的要求。

　　如果工厂不生产最终成品，不需要这个程序。

　　Supplier Management Does the supplier approval procedure include clear criteria forongoing assessment and the standards of performance required?

　　工厂的供应商审核程序是否包括清晰的评审指标及产品达标的相关绩效标准?

　　Procedures shall be established which include clear criteria for ongoing assessment and thestandards of performance required. Ongoing assessment may take the form of monitoringperformance through one or more of the following: in house checks; certificates of analysis;certificate of conformity; supplier audits; traceability checks, etc.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核实工厂的供货商评审程序，是否清楚地包含了持续的评估和所需绩效标准。持续评估可以采用表格通过内部检查，认证分析，法规认证，供应商评估，可追溯性检查等等的形式。

　　如果工厂不生产最终成品，不需要这个程序。

　　Supplier Management Are supplier approval records kept? 工厂是否保存供应商审核记录?

　　Supplier approval records must be retained for a minimum of 5 years after production has ended.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核对供应商审核记录是否在生产结束后，至少保存了5年。

　　如果工厂不生产最终成品，不需要这个程序。

　　Supplier Management Does the factory review the performance of suppliers against adefined criteria?

　　工厂是否根据确定的评审条件及绩效标准来评判供应商?

　　The factory is to have defined criteria for reviewing suppliers. There are to be records of thesuppliers being reviewed against this criteria.

　　Not Applicable will apply if factory does not manufacture a finished product.

　　核对工厂的供货商审核记录，证实工厂是否按照既定的评审条件及绩效标准来评估供应商。

　　如果工厂不生产最终成品，不需要这个程序。

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