Amazon验厂咨询|质量验厂之工厂环境与质量体系文件及产品设计开发控制问卷

Section 1: Factory Facilities & Environment(第一部分:工厂设施和环境)
1.1、Does factory look clean, organized, and secured in: production lines, storage of materials and products, rework / repair areas, inspection, and packing areas? Is the overall production process flow 
organized in an efficient way? (工厂整体是否干净, 整洁，安全: 包括生产线,原料仓和成品仓, 重工返修区,检查和包装区? 总体的生产流程设置高效？)
1.2 CCP、Does factory have the right facilities (incl. production equipment, tooling) for manufacturing of the products being sourced? Are the maintenances / status of the facililities look good？ 
(工厂是否有合适的设施(包括生产机器和工装用具)用于生产所采购产品？这些设施的维护保养是否在好的状态?)
1.3、Does factory have and maintain sanitation and/or pest controls in certain production workshops and / or warehouses, as necessary, to ensure products' quality and compliance? 
(必要时,工厂是否在特定的生产车间和仓库设立并执行卫生及虫害防治, 以确保产品质量和合规？)
Section 2: Quality System, Documentation Control, Training(第二部分:质量体系, 文件管理, 培训)
2.1、Does factory have a documented quality manual to define the factory's quality policy, quality objectives, organization, roles and responsibilities in quality management, and, outline the high level quality operations? Have the quality manual contents been clearly communicated and understood by factory's management staff? (工厂是否有文件化的质量手册去确定工厂的质量方针, 质量目标,组织结构及质量管理的权责，并且概述出质量运作要求, 并且质量手册的相关内容在内部进行充分的沟通并被管理层理解)
2.2、Does factory have documented operation procedures and necessary work instructions to guide people to operate consistently and effectively achieve results as expected, and the procedures and work instructions have been communicated and understood by related employees? 
(工厂是否有文件化的操作指引和必要的工作指引去指导员工一致性操作并有效地达到期望的结果，并且程序和工作指引被相关员工充分了解)
2.3、Does factory control documents properly, i.e. review and approval, distribution, change control, etc.? The controlled documents should include external standard documents, and technical documents like spec., drawing, BOM, standard samples, etc.. 
(工厂是否正确地进行文件控制,像文件审核,批准,分发,变更控制等?受控文件应该包括外部标准文件; 内部规格,图纸,物料清单,标准样板等技术文件)
2.4、Does factory clearly define quality records needs in various quality operations, and the retention time of those records? (工厂是否清晰的规定了哪些质量控制位需要质量记录以及记录的保存时间)
2.5、Does factory properly keep the quality records, that includes identification, keeping in rigth environment, easy retrieval of records, etc.? (工厂是否正确地保存质量记录,包括标识,保存环境以及易于取得等)
2.6 CCP、Does factory have an independent Quality Department, with QA/QC personnel authorized to inspect products and materials, and take necessary actions to assure quality? (工厂是否有独立的质量部门, 
有授权的QA/QC人员检验产品和原料,并采取必要的质量保证措施.)
2.7、Does factory have a well planned and implemented training program for workforces and QA/QC personnel, that includes training of product knowledge, production processes, inspection & testing, and, right operations of production, testing, and measuring equipment in production and in-house lab? 
(工厂是否很好地规划和执行全体员工及QA/QC人员培训体系,内容包括产品知识,生产流程,检查和测试,正确的操作生产线和实验室的生产,计量和测试等设备)
2.8、Do factory's on-job production and QA/QC personnel have adequate knowledge of quality requirements for the product categories being sourced, relevant materials, and the production processes? (工厂员工和QA/QC人员对相关产品,原料的质量要求以及生产流程是否有足够的知识)
Section 3: Product Development Control (第三部分: 产品设计开发控制)
3.1、Does factory have right knowledge, experiences and competent engineers / technicians to develop the type of products being sourced? (工厂是否有具备正确的知识,经验和能胜任的工程师/技术员去开发客户需要的产品)
3.2、Does factory have a process to review with customers to define product requirements, that should include certain spec., product performance, safety, durability, etc. for product development? 
(工厂是否有相应的流程规定在确定产品要求前先和客户充分沟通,沟通开发过程中的产品标准,表现,安全,可靠性等)
3.3、Does factory have product development plans to outline product development stages, covering development of product (construction, functions, materials etc.), prototype / sample making, review / verification arrangement for the product developed, etc.? Does factory conduct necessary reviews, verifications at various stages of product development according to the plan? 
(工厂是否有详细的开发计划去定义好以下开发进程，包括产品结构/功能, 需要的物料,手板样本制作, 产品设计的审核/确认等? 工厂是否按产品开发计划安排了必要的产品开发检讨，验证?)
3.4、Does factory's product development output right / updated product spec., drawings, and/or samples, to provide data, requirements, and instructions for production, purchasing, and quality controls? 
(工厂设计开发阶段是否有以下输出:正确的产品规格,图纸,样板,并为生产,采购,质量控制提供相应的资料，要求，和指引.)
3.5、Does factory have competent engineer / technician, and a process in place to develop, review / verify package construction which is sufficient to protect the type of products? 
(工厂是否有能胜任的工程师/技术员, 及相关工作流程去开发,审核/确认产品包装结构)
3.6、Does factory have in-house capability to develop, review / verify User Manual, Assembly Instruction, etc. for the type of products? (工厂是否有能力自己开发,审核/确认用户手册,装配说明书等).
3.7 CCP、Does factory conduct right and complete tests (incl. submission to 3rd party test) to verify that final product complies to the customer's and regulatory requirements before release for production? 
(在量产前,工厂是否进行正确的产品测试(或第三方测试)去确认产品对于客户要求和法规要求的符合性)
3.8、Does factory hold Pre-Production Meeting to communicate product quality requirements to production teams before mass production starts? (在量产前,工厂是否举行产前会议交接产品质量要求给生产部门)
3.9、Does factory have a process to control (evaluate, approve, communicate) changes to product / package after product / package has been approved, that includes communicating the changes to customer's approval? (工厂是否有相应的流程去管控产品/包装工程变更, 包括通知客户并得到客户的批准)