工厂QMS质量体系/品质验厂审核清单

Quality Management System Audit Checklist
(质量体系审核清单)

Section 1: Factory Facilities & Environment

(第一部分:工厂设施和环境)

1.1、"Does factory look clean and organized in: production lines, storage of materials and products, rework
/ repair areas, inspection, and packing areas?
(工厂整体是否干净整齐: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 have sufficient lighting and ventilation in relevant working / storage areas?
(工厂在相关工作和储存区域是否有足够的光照和通风?)

1.3、"Does factory maintain a suitable and secure environment for production and storage of products?
(工厂是否保持适宜的以及安全的产品生产和储存环境?)

1.4、"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?)

1.5、"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 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 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）

3.3、"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)

3.4、"Does factory'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
)

3.5、"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产出:更新且正确的产品规格,图纸,样板,并为生产,采购,质量控制提供相应的指引.)

3.6、"Does factory have a process to control (propose, review & approve, communicate) changes to product / package, that includes communicating the changes to customer's approval?
(工厂是否有相应的流程去管控产品/包装变更, 包括通知客户并得到客户的批准)

3.7、"Does factory have competent engineer / technician who can develop, review / verify product package
contruction for the type of products? 
(工厂是否有能胜任的工程师/技术员能开发,审核/确认产品包装结构)

3.8、Does factory have in-hosue 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)

3.9、"Does factory conduct right product tests (or submit to 3rd party test) to verify that 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)

3.10、"Does factory hold in house 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)

4.1、"Does factory have a method / process to evaluate and select its suppliers (incl. subcontractors) based on their ability to meet quality requirements and delivery requirements?
(工厂是否有建立评估和选择供应商(包括分包商)的流程,基于供应商满足质量和交货方面要求的能力)

4.2、"Does factory have a method / process to evaluate and approve the materials / components before
purchase? 
(在采购之前工厂是否有方法/流程去评估和批准原材料/零件)

4.3、"Does factory clearly communicate quality requirements to its suppliers when purchase materials or
outsource any production processes?
(当采购原物料或者外购任何半成品时工厂是否清晰的与供应商沟通其质量要求).

4.4、"Does factory have a mechanism to measure suppliers' quality performances to ensure right suppliers are being used to consistently supplying right quality materials / components
(工厂是否有评估供应商质量水平的机制去保证正确的供应商稳定地提供正确的物料/零件.)

4.5、"Does factory clearly define inspection and testing requirements for incoming materials / components, that should include sampling plan, inspection / test items, acceptance criteria?
(工厂是否清晰地定义原材料和零件的检验和测试要求, 包括抽样计划,检验/测试内容,收货标准等)

4.6、"Does factory conduct inspection / tests for incoming materials / compoents according to the defined requirements, documented drawing / spec., product requirements, reference samples, and certain inspection / testing work instructions? 
(工厂是否按照定义的要求进行原物料/零件的检验/测试,
定义的要求包括受控的图纸/标准, 产品要求, 客户样板, 以及检验/测试指导书等)

4.7、"Does factory request for test report and/or compliance certificate (e.g.: RoHS, CA Prop 65) for the materials / components from suppliers to prove quality and compliance when factory itself is not able
to inspect / test them? 
(当工厂自己没有能力检验/测试时,
是否要求供应商提供相关测试报告/符合性证明书(ROHS,CA65)证明采购物料的质量和符合性)

4.8、"Does factory clearly identify inspection status for incoming goods, separate the goods that passed inspection, not inspected, failed inspection, or, segregated materials for specific markets, e.g.: CARB P2 from other noncompliant materials, etc. properly to prevent mix or unintended
use?
(工厂是否清晰地定义来料的检验状态, 正确区分出检验合格, 待检验, 检验不合格, 不同目标市场物料等, 区分CARB
物料和其他不符合CARB物料避免混用和非预期使用)

4.9、"Does factory clearly define and implement processes / authorities for disposition of  nonconforming incoming goods, that could be RTV, rework & reinspect, approved concession?
(工厂是否清晰地定义并执行来料不良品处理的流程/权限, 可能是退货, 重工, 重检验, 批准豁免)

4.10、"Does factory keep incoming inspection records and the relevant disposition records, that demonstrate effective execution of incoming inspection operation?
(工厂是否保存好来料检验记录和相关处理记录, 证明工厂有效地执行来料检验)

4.11、"Does factory store the materials and components in areas / warehouses with appropriate environment, stack and rotate stocks properly, like FIFO (First In First Out) to prevent materials / components from deterioration or over stock due date?
(工厂的原物料/零件仓是否有合适的储存环境,正确的储存和周转, 执行先进先出避免原物料/零件劣化或过期)

4.12、"Does factory identify products / materials properly with models,, item #, receiving dates, etc. to  prevent unintended use of wrong quality materials /
products?
(工厂是否用模型,物料编号,来料日期等正确地识别物料/产品, 避免非预期使用错误的物料/产品.)

4.13、Does factory separate RoHS/REACH and non-RoHS/non-REACH goods properly in all storage areas?
(工厂是否严格地区分ROHS和非ROHS,/REACH和非REACH物料)

4.14、Does factory handle, transport materials, components and WIPs appropriately to prevent products from damages, scratches, etc.? 
(工厂是否正确地处理,运送相关原料,零件和半成品而避免损坏和刮花等)、

4.15、"Does factory do regular stock taking, and control receiving and dispatching of inventories properly?
(工厂是否有周期性的库存盘点, 确保收发账目的正确性)

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

5.1、"Does factory plan productions properly for customers' orders, by considering purchasing and production lead time, available capacity, etc., and maintain a good record of on-time delivery?
(对于客户订单工厂是否有准确的生产计划, 考虑采购和生产准备时间, 可用产能等, 保持好的准时交货表现.)"

5.2、"Does factory have a process plan for individual products, to outline manufacturing processes (incl. outsourced ones), identifying key process control points?
(工厂是否有流程计划,概述出整个制造流程(包括外包流程), 识别出关键控制点

5.3、"Does factory arrange manufacturing processes with appropriate allocation of material / component, equipment, working forces, in-process inspection / tests, etc. for the products? Where product quality can't be verified by subsequent inspection/ testing, the process has been validated?
(工厂是否正确地安排生产, 恰当地分配物料/零件,设备,人力,过程检验/测试等, 当某工位产品质量不能被后续检验/测试证实时,此工位必须是被验证过的)

5.4、"Does factory prepare and provide necessary work instructions, reference samples, etc. with defined working methods, quality acceptance criteria, and/or defects classifications, at certain workstations for
production or inspection use?
(工厂是否准备好必要的工作指引,参考样板等, 在确定的工位有已经定义好的工作方法,
质量接收标准, 以及不良分类等支持生产和检验）

5.5、"Does factory's Production/QC review and sign off the first articles of in-process and finished products to ensure that they meet the requirements with regard to specification, quality &
safety?
(工厂生产/QC是否在过程和成品阶段审核及签发首件来保证产品满足规格,质量及安全方面的要求.)

5.6、"Does factory use appropriate jigs / fixtures as necessary to control consistency of positions, direction, level, gaps etc. in relevant production processes?
(在相关的生产制程,工厂是否应用适当的工装夹具控制位置,方向,水平面,缝隙的一致性)

5.7、"Does factory control process parameters (like: temperature, humidity, speed, torque, pressure, etc.) in production to ensure product quality is achieved?
(工厂是否控制关键制程参数(温度,湿度,速度,扭力,压力等)来确保质量的达成)

5.8、"Does factory production select right quality materials / components, and/or control recycle  materials percentage (e.g.: plastic injection materials) for production use, to ensure the output products having right quality?
(工厂是否选择正确的原料/零件,以及控制再生料的比率(注塑塑胶料),以达到产品的正确质量)

5.9、"Does factory production always apply sufficient auxiliary materials (like glue, paint), and use proper
production reference samples (like color panels) to control production processes, to ensure product construction integrity and finish conformity?
(工厂是否经常应用足够的辅助物料(胶水,颜料),
并且应用适当的参考样板(色版)去控制生产过程, 以达到产品结构和成品的符合性)

5.10、"Does factory plan and conduct production equipment maintenances properly, to ensure precision and good conditions of the production equipment? 
(工厂是否适当地策划和执行生产设备保养,
以确保生产设备的精确度和好的状态)

5.11、"Does factory have production lines and toolings solely dedicated for RoHS/REACH compliant
products
(工厂是否有单独符合ROHS标准,REACH标准的生产线和生产设备)

5.12、"Does factory have method to control and prevent risks of physical, chemical and biological (incl. molds) contaminations that may damage the product and/or
personnel?
(工厂是否有方法控制和预防物理,化学及生物污染等可能造成产品/人员的损坏)

5.13、"Does factory define, communicate, and correctly follow the package requirements (package materials, package method, labeling, packing list, etc.) in
production?
(生产中工厂是否定义,沟通并且正确地遵照包装要求(包装材料,包装方法,标签,包装清单等)

5.14、Does factory identify products / components properly in production to prevent unintended use, where necessary, provide traceability? 
(工厂是否正确地识别生产中的产品和零件以避免非预期的使用,必要时要可追溯.)

5.15、"Does factory clearly define in-process inspections, include inspection needs at various stages, frequency / sampling plan, inspection and testing methods, equipment to use, quality requirements and acceptance criteria, etc.?
(工厂是否清晰地定义过程检验,包括检验点,检验频率/抽样计划,检验和测试方法,检验仪器,质量要求及接收标准)

5.16、"Does factory conduct in-process inspections according to the defined requirements, at appropriate stations, against the defined product spec., drawing, sample, etc.?
(工厂是否按照确定的要求进行过程检验,包括检验点,确定的产品规格,图纸,样板等)

5.17、"Does factory record inspection results and findings, feedback / review with productions as
appropriate?
(工厂是否记录检验结果和发现,并恰当地向生产部门反馈)

5.18、"Does factory clearly identify inspection status of products in production lines, segregate
nonconforming products properly? 
(工厂是否清晰地识别产品的检验状态, 正确地区分出不合格品)

5.19、"Does factory define and implement processes / authorities for disposition of nonconforming 
products in productions, that could be rework & reinspect, approved concession, etc.?
(工厂是否定义和执行不良品处理流程和权限, 可能包括重工,重检,批准豁免)

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

6.1、"Does factory clearly define inspection requirements for the finished products, especially for critical features like, construction, performances, safety and serviceability, etc., and, define the inspection sampling plan, acceptance criteria?
(工厂是否清晰地定义成品的检验要求,特别是结构,表现,安全和适用性等,定义检验抽样计划和接收标准)

6.2、"Does factory train its QA/QCs to clearly understand quality requirements for the products and  inspection processes (i.e.: inspection and test items / needs, methods & tooling, frequencies / sampling plan, acceptance criteria, etc.)?
(工厂是否培训QA/QC人员理解产品和检验过程的质量要求(检验和测试项目,方法,测试设备,频率,抽样计划,接收准则等)

6.3、"Does factory conduct final inspections according to the defined process, against relevant drawings /
specifications, product specific requirements, reference samples, and conduct adequate tests to verify products' safety, and fit for use, durability, etc.?
(工厂是否按照定义好的流程进行终检,依据相关的图纸/规格,特殊产品要求,参考样板,并进行足够的测试去验证产品的安全性,使用功能,耐用性等)

6.4、"Does factory record final inspection results and findings, feedback / review with productions for corrective action / improvement opportunties?
(工厂是否记录终检结果和发现,并反馈给生产部门作为纠正和改善机会)

6.5、"Does factory clearly identify inspection status of final products, segregate nonconforming products
properly?  
(工厂是否清晰地识别检验产品的状态, 隔离出不良品)

6.6、"Does factory define and implement a process to dispose the rejected products, that could be: rework and re-inspection, accept on deviation, etc., and, communicate to customer's
approval?
(工厂是否有定义和执行不良品处理流程, 可能包括重工,重检,接收差异等, 并且得到客户的批准)

6.7、"Does factory have a correct shipping operation process in place to control that products are NOT  shipped until they have passed final inspection?
(工厂是否有正确的出货流程,确保产品通过终检合格后才能出货)

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

7.1、"Does factory maintain the gauges, measuring / test equipment always in a good / usable condition?
(工厂是否一直保持测量仪器,测量/测试设备在好的可用的状态)

7.2、"Does factory have a master list and plan for calibration of the measuring and test equipment that
are used in production, inspections for receiving goods, in-process & final products, and test operations? 
(工厂是否有测量/测试设备清单和校正计划,包括生产使用/来料检验/过程检验/产品终检以及测试阶段的测量测试设备)

7.3、Does factory arrange calibrations for all measuring and test equipment at appropriate intervals to ensure the equipment are suitable and accurate to measure and verify products' acceptance, and the calibrations are traceable to national / international standards?
(工厂是否在恰当的时间间隔安排测量/测试设备的校正,以保证设备能恰当和精确地验证产品,并且相关校正符合国家/国际标准)

7.4、"Does factory record, identify calibrations, define and implement a procedure to recall products when equipment is found not in calibration
status?
(工厂是否记录,识别校正结果,有定义好的召回流程，当发现测量/测试设备没被校正好时执行召回流程.)

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

8.1、"Does factory have a CAP process, that should define conditions to initiate CAP, and the CAP work flow should include containment, causes investigation, corrective actions to eliminate causes and prevent recurrence, and follow up / verify effectiveness?
(工厂是否有纠正和预防措施流程,应该包括什么情况发行CAP,CAP流程应该包括围堵措施,原因调查,消除原因的纠正措施和预防措施,以及跟进/确认有效性).

8.2、"Does factory have a method to review and respond to customer complaints / returns / claims that includes customer's inspection / testing fails, and, the factory investigates causes, takes necessary corrective actions to prevent recurrence?
(工厂是否有流程回复客户抱怨/退货/投诉(包括客户检验和测试不良),工厂是否调查原因,执行必要的纠正预防措施防止再次发生)

8.3、"Does factory request for and follow up necessary corrective actions when there are significant quality issues happened in factory's productions or with products from its suppliers, etc.? 
(当生产中或供应商产品有重大质量问题时工厂是否执行或要求必要的纠正预防措施)"

8.4、"Does factory do necessary quality data collection and analysis by using certain quality tools, so as to precisely identify quality problems and improvement opportunities? 
(工厂是否有一些必要的质量数据收集和分析，以准确的识别质量问题和改善机会)"

8.5、Does factory initiate corrective actions and/or quality improvement projects based on quality data analysis? 
(工厂是否基于质量数据分析而启动一些纠正预防措施或质量改善项目)