第一部分:工廠設(shè)施和環(huán)境 Section 1: Factory Facilities & Environment

1.1 Does factory look clean, organized, and secured in: production lines, storage of materials and products, rework / repair areas, inspection, and packing areas?
(工廠整體是否干凈, 整潔，安全: 包括生產(chǎn)線,原料倉和成品倉,重工返修區(qū),檢查和包裝區(qū)?)

1.2 Does factory's facilities (incl. production equipment, tooling) and their maintenances look good?
(工廠的設(shè)施(包括生產(chǎn)機器和工裝用具)以及相應(yīng)的維護保養(yǎng)是否是好的狀態(tài)?)

1.3 Does factory have and maintain sanitation and/or pest controls in certain production workshops and / or warehouses, as necessary?
(必要時,工廠是否在特定的生產(chǎn)車間和倉庫設(shè)立并執(zhí)行衛(wèi)生及蟲害防治？)

第二部分:質(zhì)量體系,文件管理,培訓 Section 2: Quality System, Documentation Control, Training

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?
(工廠是否有文件化的質(zhì)量手冊去確定工廠的質(zhì)量方針,質(zhì)量目標,組織結(jié)構(gòu)及質(zhì)量管理的權(quán)責，并且概述出質(zhì)量運作要求, 并且質(zhì)量手冊的相關(guān)內(nèi)容在內(nèi)部進行充分的溝通并被管理層理解)

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?
(工廠是否有文件化的操作指引和必要的工作指引去指導(dǎo)員工一致性操作并有效地達到期望的結(jié)果，并且程序和工作指引被相關(guān)員工充分了解)

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..
(工廠是否正確地進行文件控制,像文件審核,批準,分發(fā),變更控制等?受控文件應(yīng)該包括外部標準文件; 內(nèi)部規(guī)格,圖紙,物料清單,標準樣板等技術(shù)文件)

2.4 Does factory clearly define quality records needs in various quality operations, and the retention time of those records?
(工廠是否清晰的規(guī)定了哪些質(zhì)量控制位需要質(zhì)量記錄以及記錄的保存時間)

2.5 Does factory properly keep the quality records, that includes identification, keeping in rigth environment, easy retrieval of records, etc.?
(工廠是否正確地保存質(zhì)量記錄,包括標識,保存環(huán)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?
(工廠是否有獨立的質(zhì)量部門, 有授權(quán)的QA/QC人員檢驗產(chǎn)品和原料,并采取必要的質(zhì)量保證措施.)

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?
(工廠是否很好地規(guī)劃和執(zhí)行全體員工及QA/QC人員培訓體系,內(nèi)容包括產(chǎn)品知識,生產(chǎn)流程,檢查和測試,正確的操作生產(chǎn)線和實驗室的生產(chǎn),計量和測試等設(shè)備)

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?
(工廠員工和QA/QC人員對相關(guān)產(chǎn)品,原料的質(zhì)量要求以及生產(chǎn)流程是否有足夠的知識)

第三部分:產(chǎn)品設(shè)計開發(fā)控制 Section 3: Product Development Control

3.1 Does factory have right knowledge, experiences and competent engineers / technicians to develop the type of products being sourced?
(工廠是否有具備正確的知識,經(jīng)驗和能勝任的工程師/技術(shù)員去開發(fā)客戶需要的產(chǎn)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?
(工廠是否有相應(yīng)的流程規(guī)定在確定產(chǎn)品要求前先和客戶充分溝通,溝通開發(fā)過程中的產(chǎn)品標準,表現(xiàn),安全,可靠性等)

3.3 Does factory have product development plans to outline product development stages, covering development of products' construction, functions, materials etc., prototype / sample making, review / verification arrangement for product design, etc.?
(工廠是否有詳細的開發(fā)計劃去定義好以下開發(fā)進程，包括產(chǎn)品結(jié)構(gòu)/功能, 需要的物料,手板樣本制作, 產(chǎn)品設(shè)計的審核/確認等)

3.4 (*CCP*) 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?
(工廠設(shè)計開發(fā)階段是否有以下輸出:正確的產(chǎn)品規(guī)格,圖紙,樣板,并為生產(chǎn),采購,質(zhì)量控制提供相應(yīng)的資料，要求，和指引.)

3.5 Does factory conduct necessary reviews, verifications at various stages of product development according to the plan?
(工廠是否按產(chǎn)品開發(fā)計劃安排了必要的產(chǎn)品開發(fā)檢討，驗證).

3.6 Does factory have competent engineer / technician who can develop, review / verify package construction which is sufficient to protect the type of products?
(工廠是否有能勝任的工程師/技術(shù)員能開發(fā),審核/確認產(chǎn)品包裝結(jié)構(gòu))

3.7 Does factory have in-house capability to develop, review / verify User Manual, Assembly Instruction, etc. for the type of products?
(工廠是否有能力自己開發(fā),審核/確認用戶手冊,裝配說明書等).

3.8 (*CCP*) 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?
(在量產(chǎn)前,工廠是否進行正確的產(chǎn)品測試(或第三方測試)去確認產(chǎn)品對于客戶要求和法規(guī)要求的符合性)

3.9 Does factory hold Pre-Production Meeting to communicate product quality requirements to production teams before mass production starts?
(在量產(chǎn)前,工廠是否舉行產(chǎn)前會議交接產(chǎn)品質(zhì)量要求給生產(chǎn)部門)

3.10 Does factory have a process to control (evaluate, approve, communicate) changes to product / package after product has been approved, that includes communicating the changes to customer's approval?
(工廠是否有相應(yīng)的流程去管控產(chǎn)品/包裝工程變更, 包括通知客戶并得到客戶的批準)

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

4.1 Does factory have a method / process to evaluate and select its suppliers (incl. subcontractors) based on their ability to meet quality and on-time delivery requirements?
(工廠是否有建立評估和選擇供應(yīng)商(包括分包商)的流程, 基于供應(yīng)商滿足質(zhì)量和準時交貨要求的能力)

4.2 Does factory have a mechanism to measure suppliers' quality performances to ensure right suppliers are being used to consistently supplying right quality materials / components?
(工廠是否有評估供應(yīng)商質(zhì)量水平的機制去保證正確的供應(yīng)商穩(wěn)定地提供正確的物料/零件.)

4.3 (*CCP*) Does factory have a method / process to evaluate and approve the materials / components before purchase?
(在采購之前工廠是否有方法/流程去評估和確定原材料/零件)

4.4 Does factory clearly communicate quality requirements to its suppliers when purchase materials or outsource any production processes?
(當采購原物料或者外購任何半成品時工廠是否清晰的與供應(yīng)商溝通其質(zhì)量要求).

4.5 Does factory clearly define inspection and testing requirements for incoming materials / components, that should include sampling plan, inspection / test items, acceptance criteria?
(工廠是否清晰地定義原材料和零件的檢驗和測試要求, 包括抽樣計劃,檢驗/測試內(nèi)容,收貨標準等)

4.6 (*CCP*) 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? Are IQC records kept?
(工廠是否按照定義的要求進行原物料/零件的檢驗/測試, 定義的要求包括受控的圖紙/標準, 產(chǎn)品要求, 客戶樣板, 以及檢驗/測試指導(dǎo)書等? 有保留IQC記錄嗎？)

4.7 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?
(工廠是否清晰地定義來料的檢驗狀態(tài), 正確區(qū)分出檢驗合格, 待檢驗, 檢驗不合格, 不同目標市場物料等, 區(qū)分CARB 物料和其他不符合CARB物料避免混用和非預(yù)期使用)

4.8 Does factory clearly define and implement processes / authorities for disposition of nonconforming incoming goods, that could be RTV, rework & reinspect, approved concession? Are disposition records kept?
(工廠是否清晰地定義并執(zhí)行來料不良品處理的流程/權(quán)限, 可能是退貨, 重工, 重檢驗, 批準豁免. 有保留不合格品處理的記錄嗎？)

4.9 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?
(工廠的原物料/零件倉是否有合適的儲存環(huán)境,正確的儲存和周轉(zhuǎn), 執(zhí)行先進先出避免原物料/零件劣化或過期)

4.10
Does factory identify products / materials properly with models,, item #, receiving dates, etc. to prevent unintended use of wrong quality materials / products?
(工廠是否用模型,物料編號,來料日期等正確地識別物料/產(chǎn)品, 避免非預(yù)期使用錯誤的物料/產(chǎn)品.)

4.11 Does factory handle, transport materials, components and WIPs appropriately to prevent products from damages, scratches, etc.?
(工廠是否正確地處理,運送相關(guān)原料,零件和半成品而避免損壞和刮花等)

第五部分:生產(chǎn)和過程質(zhì)量控制 Section 5: Production and In-process Quality Control (General Part)

5.1 Does factory plan productions properly for customers' orders, by considering purchasing and production lead time, workforces, available capacity, etc., and have means to manage productions in peak seasons? Does factory maintain a good record of on-time delivery?
(工廠能否基于工廠的采購及生產(chǎn)周期，人力和產(chǎn)能，合理按客戶訂單安排生產(chǎn)，并有能力在高峰期管理好生產(chǎn)？工廠是否保持良好的（90%）準時交貨率？)

5.2 Does factory organize PFMEA to study its manufacturing processes (incl. outsourced processes) for the type of products, understanding severities, occurances, and current controls (detection), so as to identify the risky (high RNP) areas with regards to production quality controls?
(工廠是否組織"制程失效模式分析", 了解制程中對產(chǎn)品質(zhì)量影響的嚴重程度，發(fā)生的機會率，目前的控制，以識別生產(chǎn)中質(zhì)量控制的高風險區(qū)域)

5.3 Does factory plan production processes for individual products with inputs from PFMEA, to outline manufacturing processes (incl. outsourced ones), identify key process control points, define and implement sufficient quality controls, to effectively eliminate risks to quality of products in the productions?
(工廠是否依據(jù)”制程失效模式分析“的結(jié)果規(guī)劃生產(chǎn)制程（包括外發(fā)制程），對識別出來的制程中的關(guān)鍵質(zhì)量控制點安排和執(zhí)行有效的控制，以消除生產(chǎn)中導(dǎo)致產(chǎn)品質(zhì)量問題的風險)

5.4 (*CCP*) Does factory arrange manufacturing processes according to the plan, 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?
(工廠是否正確地安排生產(chǎn), 恰當?shù)胤峙湮锪?零件,設(shè)備,人力, 過程檢驗/測試等, 當某工位產(chǎn)品質(zhì)量不能被后續(xù)檢驗/測試證實時, 此工位必須是被驗證過的)

5.5 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?
(工廠是否準備好必要的工作指引,參考樣板等, 在確定的工位有已經(jīng)定義好的工作方法, 質(zhì)量接收標準, 以及不良分類等支持生產(chǎn)和檢驗.

5.6 Does factory's Production/QC review and sign off the first articles of inprocess and finished products to ensure that they meet the requirements with regard to specification, quality & safety?
(工廠生產(chǎn)/QC是否在過程和成品階段審核及簽發(fā)首件來保證產(chǎn)品滿足規(guī)格,質(zhì)量及安全方面的要求.)

5.7 Does factory use appropriate jigs / fixtures as necessary to control consistency of positions, direction, level, gaps etc. in relevant production processes?
(在相關(guān)的生產(chǎn)制程,工廠是否應(yīng)用適當?shù)墓ぱb夾具控制位置,方向,水平面,縫隙的一致性)

5.8 Does factory control process parameters (like: temperature, humidity, speed, torque, pressure, etc.) in production to ensure product quality is
achieved? (工廠是否控制關(guān)鍵制程參數(shù)(溫度,濕度,速度,扭力,壓力等)來確保質(zhì)量的達成)

5.9 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?
(工廠是否選擇正確的原料/零件,以及控制再生料的比率(注塑塑膠料),以達到產(chǎn)品質(zhì)量)

5.10 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?
(工廠是否經(jīng)常應(yīng)用足夠的輔助物料(膠水,顏料), 并且應(yīng)用適當?shù)膮⒖紭影?色版)去控制生產(chǎn)過程, 以達到產(chǎn)品結(jié)構(gòu)和成品的符合性)

5.11 Does factory plan and conduct production equipment maintenances properly, to ensure precision and good conditions of the production
equipment? (工廠是否適當?shù)夭邉澓蛨?zhí)行生產(chǎn)設(shè)備保養(yǎng), 以確保生產(chǎn)設(shè)備的精確度和好的狀態(tài))

5.12 Does the factory have an established SOP to clearly identify, segregate and isolate non-compliant materials and products in all storage areas and production processes to prevent cross contamination or unintended usage?
工廠是否在所有的儲存區(qū)域以及產(chǎn)品生產(chǎn)過程中，清晰地標識及隔離開合規(guī)的產(chǎn)品和材料與非合規(guī)的產(chǎn)品和材料，以防止它們的誤用及交叉污染？

5.13 (*CCP*) Does factory have method to control and prevent risks of physical, chemical and biological (such as: molds, needles, mixed RoHS/non-RoHS materials) contaminations that may damage the product and/or personnel?
(工廠是否有方法控制和預(yù)防物理,化學及生物污染等可能造成產(chǎn)品/人員的損壞, (比如, 發(fā)霉，斷針，RoHS和非RoHS物料混用)

5.14 Does factory define, communicate, and correctly follow the package requirements (package materials, package method, labeling, packing list, etc.) in production?
(生產(chǎn)中工廠是否定義,溝通并且正確地遵照包裝要求(包裝材料,包裝方法,標簽,包裝清單等)

5.15 Does factory identify products / components properly in production to prevent unintended use? Does factory have methods and ability to trace its finish goods' production and quality control records, and/or trace to the major components of the products, where necessary?
(工廠是否正確地識別生產(chǎn)中的產(chǎn)品和零件以避免非預(yù)期的使用, 必要時工廠能否追溯到產(chǎn)品生產(chǎn)和質(zhì)量控制記錄,和/或追隨到關(guān)鍵部件)

5.16 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.?
（工廠是否清晰地定義過程檢驗,包括檢驗點,檢驗頻率/抽樣計劃,檢驗和測試方法, 檢驗儀器, 質(zhì)量要求及接收標準）

5.17 (*CCP*) Does factory conduct in-process inspections according to the defined requirements, at appropriate stations, against the defined product spec., drawing, sample, etc.?
(工廠是否按照確定的要求進行過程檢驗, 包括檢驗點,確定的產(chǎn)品規(guī)格,圖紙,樣板等)

5.18 Does factory record inspection results and findings, feedback / review with productions as appropriate?
(工廠是否記錄檢驗結(jié)果和發(fā)現(xiàn),并恰當?shù)叵蛏a(chǎn)部門反饋)

5.19 Does factory clearly identify inspection status of products in production lines, segregate nonconforming products properly?
(工廠是否清晰地識別產(chǎn)品的檢驗狀態(tài), 正確地區(qū)分出不合格品)

5.20 Does factory define and implement processes / authorities for disposition of nonconforming products in productions, that could be rework & reinspect, approved concession, etc.?
(工廠是否定義和執(zhí)行不良品處理流程和權(quán)限, 可能包括重工,重檢,批準豁免)

第六部分:最終成品檢查及測試 Section 6: Final Inspection &Test

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?
(工廠是否清晰地定義成品的檢驗要求,特別是結(jié)構(gòu),表現(xiàn),安全和適用性等,定義檢驗抽樣計劃和接收標準)

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.)?
(工廠是否培訓QA/QC人員理解產(chǎn)品和檢驗的質(zhì)量要求(檢驗和測試項目,方法,測試設(shè)備,頻率,抽樣計劃,接收準則等)

6.3 (*CCP*) 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.?
(工廠是否按照定義好的流程進行終檢,依據(jù)相關(guān)的圖紙/規(guī)格,特殊產(chǎn)品要求,參考樣板,并進行足夠的測試去驗證產(chǎn)品的安全性,使用功能,耐用性等)

6.4 Does factory have right measuring and testing equipment for final product's inspection and tests?
(工廠是否有合適的測量和測試設(shè)備用于最終產(chǎn)品的檢測？)

6.5 Does factory record final inspection results and findings, feedback / review with productions for corrective action / improvement opportunties?
(工廠是否記錄終檢結(jié)果和發(fā)現(xiàn),并反饋給生產(chǎn)部門作為糾正和改善機會)

6.6 Does factory clearly identify inspection status of final products, segregate nonconforming products properly? (工廠是否清晰地識別檢驗產(chǎn)品的狀態(tài), 隔離出不良品) 3

6.7 Does factory plan and execute regular product lab tests from continuous mass production, to ensure product quality consistency in terms of materials, components, constructions, workmanship, etc., (i.e.: minimun once a year for each individual design), as necessary?
(工廠是否有計劃和有效執(zhí)行必要的定期產(chǎn)品測試，以確保大貨生產(chǎn)產(chǎn)品質(zhì)量的一致性，包括材料，零部件，結(jié)構(gòu)，工藝等等 （比如對每一款設(shè)計的產(chǎn)品至少一年一次的型式實驗）

6.8 (*CCP*) 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?
(工廠是否有定義和執(zhí)行不良品處理流程, 可能包括重工,重檢,接收差異等, 并且得到客戶的批準)

6.9 Does factory have a correct shipping operation process in place to control that products are NOT shipped until they have passed final inspection?
(工廠是否有正確的出貨流程,確保產(chǎn)品通過終檢合格后才能出貨)

第七部分:計量和測試設(shè)備的控制 Section 7: Control of Measuring and Testing Equipment

7.1 Does factory maintain the gauges, measuring / test equipment always in a good / usable condition?
(工廠是否一直保持測量儀器,測量/測試設(shè)備在好的可用的狀態(tài))

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 inspection and test operations?
(工廠是否有測量/測試設(shè)備清單和校正計劃, 包括生產(chǎn)使用/來料檢驗/過程檢驗/產(chǎn)品終檢以及 測試階段的測量測試設(shè)備)

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?
(工廠是否在恰當?shù)臅r間間隔安排測量/測試設(shè)備的校正,以保證設(shè)備能恰當和精確地驗證產(chǎn)品,并且相關(guān)校正符合國家/國際標準)

7.4 Does factory record, identify calibrations, define and implement a procedure to recall products when equipment is found not in calibration status?
(工廠是否記錄,識別校正結(jié)果,有定義好的召回流程，當發(fā)現(xiàn)測量/測試設(shè)備沒被校正好時執(zhí)行召回流程.)

第八部分:改正措施計劃和持續(xù)改善 Section 8: CAP, Crisis Mgt, and Continuous Improvement

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?
(工廠是否有糾正和預(yù)防措施流程,應(yīng)該包括什么情況發(fā)行CAP,CAP流程應(yīng)該包括圍堵措施,原因調(diào)查,消除原因的糾正措施和預(yù)防措施,以及跟進/確認有效性).

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?
(工廠是否有流程回復(fù)客戶抱怨/退貨/投訴(包括客戶檢驗和測試不良),工廠是否調(diào)查原因,執(zhí)行必要的糾正預(yù)防措施防止再次發(fā)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.?
(當生產(chǎn)中或供應(yīng)商產(chǎn)品有重大質(zhì)量問題時工廠是否執(zhí)行或要求必要的糾正預(yù)防措施)

8.4 Does factory collect quality data and analyze data with certain quality analysis tools, so as to precisely identify quality problems and improvement opportunities? Does factory initiate corrective actions and/or quality improvement projects based on quality data analysis?
(工廠是否有一些必要的質(zhì)量數(shù)據(jù)收集和分析，以準確的識別質(zhì)量問題和改善機會？工廠是否基于質(zhì)量數(shù)據(jù)分析而啟動一些糾正預(yù)防措施或質(zhì)量改善項目 )

8.5 Does the factory conduct internal audits of SOPs and other internal procedures? Are the audit results captured properly and CAPA (Corrective Action and Preventive Action) porperly documented and executed?
（工廠是否對內(nèi)部質(zhì)量管理的SOP執(zhí)行情況進行內(nèi)審，并對內(nèi)審發(fā)現(xiàn)的問題要求并執(zhí)行糾正預(yù)防措施？）

8.6 Does the factory have a process in place to manage various crisis situations such as breakdown of production equipment or lines, evacuation of the facility, major supplier bankruptcy, strikes…?
(工廠是否有方法有效管理各種危機，比如，生產(chǎn)設(shè)備或生產(chǎn)線故障，工廠疏散，主要供應(yīng)商破產(chǎn)，罷工，等等？)

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