亚马逊公司（Amazon，简称亚马逊；NASDAQ AMZN），是美国最大的一家网络电子商务公司，位于华盛顿州的西雅图，也是网络上最早开始经营电子商务的公司之一，亚马逊成立于1995年，一开始只经营网络的书籍销售业务，后来扩及范围到其他产品，已成为全球商品品种最多的网上零售商和全球第二大互联网企业

Amazon质量审核清单

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?

(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?)

1.2 Does factory's facilities (incl. production equipment, tooling) and their maintenances look good?

(工厂的设施(包括生产机器和工装用具)以及相应的维护保养是否是好的状态?)

1.3 Does factory have and maintain sanitation and/or pest controls in certain production workshops and / or warehouses, as necessary? (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？)

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, objectives, and outline the high level quality operations? And the quality manual contents have 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,并且概述出高级别的质量活动,并且质量方针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 are 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 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 good knowledge on safety and regulatory requirements in US/CA/EU/JP markets for the type of products, such as CARB，CA Prop 65 (limits, contaminations)?

(工厂是否了解不同市场例如美国,加拿大,欧盟,日本等的法规方面的要求, 像CARB，CA65等）

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‘s Engineering / PD team be trained / know how to apply DFMEA in product development?

(工厂开发部门是否懂得或培训过使用设计失效模式分析在产品开发中.)

3.4 Does factory organize DFMEA in product development to assess product risks and identify product CTQs? (工厂设计开发阶段是否有采用设计失效模式分析以识别产品风险和关键质量要求.)

3.5 Doesfactory's product development plan for product's construction / functions, required materials / components, prototype sample making, review / verification arrangement for product design, etc.?

(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/零件,手板样本制作, 产品设计的审核/确认等)

3.6 Does factory's engineers / technicians consider inputs from customer requirements reviews and DFMEA, eliminate the product's risks and enhance product CTQs during product development?

(工厂的工程师和技术人员是否在产品开发过程中考虑了客户要求及”产品失效模式分析“的结果，以消除产品质量风险并加强产品关键质量特性)

3.7 Does factory's product development output right / updated product spec., drawings, and/or samples, to provide 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指引.)

3.8 Does factory conduct necessary reviews, verifications at various stages of product development according to the plan?

(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).

3.9 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)

Section 4: Purchasing Control & Materials Control (第四部分:采购控制和原材料(外包)控制)

Section 5: Production and In-process Quality Control (General Part)(第五部分:生产和过程质量控制)

Section 6: Final Inspection &Test(第六部分:最终成品检查及测试)

Section 7: Control of Measuring and Testing Equipment(第七部分:计量和测试设备的控制)

Section 8: CAP and Continuous Improvement(第八部分:改正措施计划和持续改善)

Score Criteria / Explanation Rating CAP / Observation

4.0 There is documented procedure or well common understanding for the questioned requirement, all required operations are being effectively implemented and proven to be able to assure quality, provides full confidence to customers on QMS implementation.

Fully Comply

N/A

3.0 There is documented procedure or well common understanding for the questioned requirement, majority of required works are being carried out with certain effectiveness, providing confidence to customers. A few minor discrepancies may be found.

Majority Comply

No CAP, but observation point for improvement opportunity

2.0 To the questioned requirement, there are operation requirements defined (documented or commonly understood) in factory, and certain works have been carried out case by case, not able to provide customer good confidence that the works are effectively managed.

Partially Comply

CAP may be needed depends on findings

1.0 Not acceptable. There are a few rough works done to the question's requirement, but not a planned work, not able to ensure compliance and effectiveness. Or, majority of required operations are not implemented, or, the failure could result in immediate quality concern. A few rough Works

CAP is needed

原本想把全部审核文件清单复制粘贴分享给大家，但资料实在太多，比较麻烦，如果你们需要资料可以联系我，就不一一列出来了。