生产控制Are product test requirements and results reviewed prior toproduction or at the pre-production meeting and is this documentedin the meeting notes?

　　工厂是否在大货生产之前或在产前会上，查看产品测试要求和测试结果?会议记录中是否记录了相关内容?

　　Verify meeting notes document discussion of product test requirements and results.

　　核对工厂的产前会议记录中是否有讨论产品测试要求和产前测试结果的记录。

　　生产控制Are key product and quality requirements reviewed, identified anddocumented prior to production or at the pre-production meeting?

　　工厂是否在大货生产之前或在产前会上，查看、鉴别并记录产品的关键质量要求?

　　Verify key product and quality requirements have been identified through review of pre-productionmeeting notes.

　　核对工厂的产前会议记录中是否有确认产品的关键质量要求的记录。

　　生产控制Are Pre-production meeting notes/issues communicated to theappropriate personnel?

　　工厂是否将产前会中发现的问题及会议记录传达到相关的管理人员?

　　Validate factory has a process to communicate the output or action plan of the pre-productionmeeting including action items including accountability and timing.

　　核实工厂是否有程序文件要求将产前会的会议记录，相关解决方案及时传达到相关人员。

　　生产控制Does a documented process and records exist for the factory tocompare first production units to client approval sample andspecifications?

　　工厂是否有程序文件和相关记录,要求工厂的质检人员对大货首件产品与客户的确认样和工艺单进行对照确认?

　　Verify that there is a process where QC/Production compares the first production units off the lineagainst the clients approval sample and specifications. Required documentation must includeverification of measurements, construction, workmanship and if applicable corrective action plan.

　　核对工厂的程序文件及首件样检验记录，证明工厂的质检人员对生产线上产出的第一件大货样与客户的确认样和工艺单进行了比对确认。

　　大货首件样检验记录必须包括确认尺寸、结构、做工以及整改方案(如适用)。

　　生产控制Are finished goods stored in a controlled area to avoid theft, loss,damage, deterioration?

　　工厂的成品是否储放在一个被管控的区域以避免盗窃、丢失, 破损、变质?

　　Verify all finished must be in an area that is secure and not accessible by general factory population.

　　This area must have a secure perimeter and a roof. There must be assigned personnel to monitorthis room. The goods must be on pallets or shelving.

　　核实工厂的所有成品是否保存在一个安全的，普通工人不能接触的区域。该区域密闭条件良好，必需有授权的员工监管。货物应该放置在托盘上或货架上。

　　生产控制Is the identification of raw materials and components adequate toensure traceability ?

　　工厂的原材料和零配件是否有清晰的标识足以确保它们的可追溯性?

　　Verify raw materials and components can be identified to ensure traceability. This includes:

　　packaging, processing aids, intermediate/semi-processed products, part-used materials, finishedproducts and materials pending investigation. This includes materials sourced from more than onesupplier. An example would be tracing a button to its supplier; or a screw to its supplier, etc.

　　核对工厂的原材料和零部件是否有清晰的标识,以确保产品的可追溯性。包括：包装材料，生产助剂，中间产品/半成品，产品部件原料，成品，待检原料。这些物料包括从不同原料供货商采购的产品。

　　举例：根据清晰的标识追溯钮扣的供应商，螺丝钉的供应商 Production ControlIs traceability available from source of raw material and componentsthru finished product?

　　工厂的可追溯性系统是否贯穿从原材料和零部件的采购到成品出运?

　　Select a sample of different finished goods and have the factory explain & demonstrate the lot/batchidentification of the raw materials & components used to manufacture these finished goods.

　　在工厂随机抽取一个正在生产的产品,请工厂对其内部的追溯系统加以解释，证明根据原材料/零部件的标识，生产批次，可以追溯到成品的完成时间，出运批次等。

　　生产控制Does the factory test the traceability system to ensure it works?

　　工厂是否有内部测试,以鉴别自己的追溯系统的有效性?

　　Verify the factory periodically confirms that their traceability system is working. Ask the factory toprovide records in the form of reports or meeting minutes that would support the factory is ensuringthe effectiveness of the traceability system.

　　核对工厂的定期测试追溯系统的记录。工厂要提供报告或会议记录来证明工厂的追溯系统工作正常。

　　生产控制Are final products suitably marked on packaging and/or product toallow identification and traceability?

　　工厂是否在成品或者零售包装上有适当的标识，用以识别生产批次和作为追溯问题的依据?

　　Select a sample of different finished goods and verify:

　　A. Children's products have traceability labeling on packaging and product.

　　B. All other products have traceability on packaging.

　　Not Applicable will apply only if factory does not produce finished goods.

　　随机抽取工厂的几件不同的成品并核对：

　　A 儿童产品的产品自身和零售包装上要有追溯标识。

　　B 其他的产品在零售包装上有追溯标识。

　　如果工厂不生产最终成品，不需要这个程序。

　　生产控制Is there an SOP that requires customer approval when changingmaterials, components, design, or manufacturing processes that mayaffect meeting safety, regulatory and quality requirements of theproduct?

　　工厂是否有标准操作程序文件明确规定了，因为产品的原材料、零部件、设计、生产程序等方面需要改变从而影响到产品的安全性、合法性以及质量要求时，工厂必须得到客户的确认方能生产?

　　Verify the factory's written procedures for notifying customers and obtaining approval when thefactory is changing materials, components, design or manufacturing processes that could affectsafety, regulatory and quality requirements of the finished goods.

　　核对工厂的程序文件证明当产品的原材料、零部件、设计、生产程序等方面需要改变从而影响到产品的安全性、合法性以及质量要求时，工厂必须得到客户的确认方能生产。

　　生产测试计划Does the factory have a documented Production Test Plan(s) (PTP)independent of Target's requirements?

　　工厂是否有完全独立于Target质量要求之外的生产质量控制计划(Production Test Plan)?其上列明关键质量控制计划和相应的测试要求。

　　Ask for documentation that confirms the existence of a PTP.

　　核对工厂的生产质量控制计划，来确定工厂有自己内部完全独立于Target质量要求之外的质量控制程序。其上列明关键质量控制计划和相应的测试要求。

　　生产测试计划Does the PTP meet Target minimum requirements?

　　工厂的生产质量控制流程是否符合Target质量控制的最低要求?

　　Verify the PTP documentation includes the following elements of testing, inspection andmanufacturing controls:

　　1. Type2. Frequency3. Criteria核对工厂的生产质量控制流程,其上至少包含以下内容：

　　1. 测试、检验和生产质量控制的类型。

　　2. 测试、检验和生产质量控制的频率。

　　3. 测试、检验和生产质量控制的标准。

　　生产测试计划Is the PTP appropriate for the product and processes involved?

　　工厂的生产质量控制流程是否适用于工厂正在生产的产品和生产流程?

　　Is the factory's PTP appropriate when taking into consideration the product type, product risk level,site conditions, manufacturing capabilities and manufacturing controls and level of Quality Systemsimplementation.

　　核对工厂的生产质量控制流程是否全面详细而无任何缺失。综合考虑产品的类型，危险等级，现场环境，生产能力，生产过程控制和实施质量系统的完成情况。

　　生产测试计划Are there records to support the PTP is being executed asdocumented?

　　工厂是否有相关的记录来证实工厂在日常生产中非常有效的执行生产质量控制流程?

　　Review test reports, inspection results and manufacturing control records to verify the PTP is beingexecuted as written with regard to frequency, type of, criteria used, etc.

　　核对工厂的相关测试报告、检验报告的结果和生产控制记录以证明生产质量控制流程是按照既定的频率，类型,标准有效执行的。

　　控制约定的材料Does the factory have effective documented procedures for thecontrol of non-conforming materials and products includingidentification, segregation and dispositioning?

　　工厂是否有行之有效的程序文件对不合格的材料，产品进行管控?包括鉴别、存放和销毁?

　　Verify the factory has a written SOP which describes how non-conforming material is identified,segregated or kept from getting placed back in with normal production. Also, there is to be adisposition process where a documented decision is made to rework or repair, scrap or discard, use"As Is", etc. along with decisions to recertify or not, test, inspect, etc. The disposition is to identifythe person who authorized the actions.

　　核对工厂是否有标准操作程序文件，该文件说明了不合格产品如何进行鉴别、隔离、销毁以及防止其混入正常生产区域。

　　工厂是否有对于不合格产品应作出书面结论的程序，要求重做、返修、废弃以及“照常使用”等。书面结论还要有最终评判，说明不合格产品是否需要补做、额外测试、检验等。所有的处理决定均应由被授权的质检人员作出。

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