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工廠QMS質(zhì)量體系/品質(zhì)驗(yàn)廠審核清單
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Quality Management System Audit Checklist
(質(zhì)量體系審核清單)
Section 1: Factory Facilities & Environment
/ repair areas, inspection, and packing areas?
(工廠整體是否干凈整齊:包括生產(chǎn)線,原料倉(cāng)和成品倉(cāng),重工返修區(qū),檢查和包裝區(qū)?)
1.2、"Does factory have sufficient lighting and ventilation in relevant working / storage areas?
(工廠在相關(guān)工作和儲(chǔ)存區(qū)域是否有足夠的光照和通風(fēng)?)
1.3、"Does factory maintain a suitable and secure environment for production and storage of products?
(工廠是否保持適宜的以及安全的產(chǎn)品生產(chǎn)和儲(chǔ)存環(huán)境?)
1.4、"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(jī)器和工裝用具)以及相應(yīng)的維護(hù)保養(yǎng)是否是好的狀態(tài)?)
1.5、"Does factory have and maintain sanitation and/or pest controls in certain production workshops and
/ or warehouses, as necessary?
(必要時(shí),工廠是否在特定的生產(chǎn)車(chē)間和倉(cāng)庫(kù)設(shè)立并執(zhí)行衛(wèi)生及蟲(chóng)害防治？)
Section 2: Quality System, Documentation Control, Training
(第二部分:質(zhì)量體系,文件管理,培訓(xùn))
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?
(工廠是否有文件化的質(zhì)量手冊(cè)去確定工廠的質(zhì)量方針,質(zhì)量目標(biāo),并且概述出高級(jí)別的質(zhì)量活動(dòng),
并且質(zhì)量方針相關(guān)內(nèi)容在內(nèi)部進(jìn)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(dá)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(jìn)行文件控制,像文件審核,批準(zhǔn),分發(fā),變更控制等?受控文件應(yīng)該包括外部標(biāo)準(zhǔn)文件;
內(nèi)部規(guī)格,圖紙,物料清單,標(biāo)準(zhǔn)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(shí)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(biāo)識(shí),保存環(huán)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?
(工廠是否有獨(dú)立的質(zhì)量部門(mén),
有授權(quán)的QA/QC人員檢驗(yàn)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 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?
(工廠是否很好地執(zhí)行全體員工及QA/QC人員培訓(xùn)體系,內(nèi)容包括產(chǎn)品知識(shí),生產(chǎn)流程,檢查和測(cè)試,正確的操作生產(chǎn)線和實(shí)驗(yàn)室的生
產(chǎn),計(jì)量和測(cè)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(duì)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(shí))
Section 3: Product Development Control
(第三部分:產(chǎn)品設(shè)計(jì)開(kāi)發(fā)控制)
3.1、Does factory have right knowledge, experiences and competent engineers / technicians to develop the type of products being sourced?
(工廠是否有正確的知識(shí),經(jīng)驗(yàn)和能勝任的工程師/技術(shù)員去開(kāi)發(fā)客戶(hù)需要的產(chǎn)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)?
(工廠是否了解不同市場(chǎng)例如美國(guó),加拿大,歐盟,日本等的法規(guī)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(hù)充分溝通,溝通開(kāi)發(fā)過(guò)程中的產(chǎn)品標(biāo)準(zhǔn),表現(xiàn),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.?
(工廠是否有詳細(xì)的開(kāi)發(fā)計(jì)劃去定義好以下開(kāi)發(fā)進(jìn)程，包括產(chǎn)品結(jié)構(gòu)/功能,需要的物料/零件,手板樣本制作,產(chǎn)品設(shè)計(jì)的審核/確認(rèn)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?
(工廠設(shè)計(jì)開(kāi)發(fā)階段是否有以下產(chǎn)出:更新且正確的產(chǎn)品規(guī)格,圖紙,樣板,并為生產(chǎn),采購(gòu),質(zhì)量控制提供相應(yīng)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?
(工廠是否有相應(yīng)的流程去管控產(chǎn)品/包裝變更, 包括通知客戶(hù)并得到客戶(hù)的批準(zhǔn))
3.7、"Does factory have competent engineer / technician who can develop, review / verify product package
contruction for the type of products?
(工廠是否有能勝任的工程師/技術(shù)員能開(kāi)發(fā),審核/確認(rèn)產(chǎn)品包裝結(jié)構(gòu))
3.8、Does factory have in-hosue 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(kāi)發(fā),審核/確認(rèn)用戶(hù)手冊(cè),裝配說(shuō)明書(shū)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?
(在量產(chǎn)前,工廠是否進(jìn)行正確的產(chǎn)品測(cè)試(或第三方測(cè)試)去確認(rèn)產(chǎn)品對(duì)于客戶(hù)要求和法規(guī)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?
(在量產(chǎn)前,工廠是否舉行產(chǎn)前會(huì)議交接產(chǎn)品質(zhì)量要求給生產(chǎn)部門(mén))
Section 4: Purchasing Control & Materials Control
(第四部分:采購(gòu)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?
(工廠是否有建立評(píng)估和選擇供應(yīng)商(包括分包商)的流程,基于供應(yīng)商滿(mǎn)足質(zhì)量和交貨方面要求的能力)
4.2、"Does factory have a method / process to evaluate and approve the materials / components before
purchase?
(在采購(gòu)之前工廠是否有方法/流程去評(píng)估和批準(zhǔn)原材料/零件)
4.3、"Does factory clearly communicate quality requirements to its suppliers when purchase materials or
outsource any production processes?
(當(dāng)采購(gòu)原物料或者外購(gòu)任何半成品時(shí)工廠是否清晰的與供應(yīng)商溝通其質(zhì)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
(工廠是否有評(píng)估供應(yīng)商質(zhì)量水平的機(jī)制去保證正確的供應(yīng)商穩(wěn)定地提供正確的物料/零件.)
4.5、"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(yàn)和測(cè)試要求, 包括抽樣計(jì)劃,檢驗(yàn)/測(cè)試內(nèi)容,收貨標(biāo)準(zhǔn)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?
(工廠是否按照定義的要求進(jìn)行原物料/零件的檢驗(yàn)/測(cè)試,
定義的要求包括受控的圖紙/標(biāo)準(zhǔn), 產(chǎn)品要求, 客戶(hù)樣板, 以及檢驗(yàn)/測(cè)試指導(dǎo)書(shū)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?
(當(dāng)工廠自己沒(méi)有能力檢驗(yàn)/測(cè)試時(shí),
是否要求供應(yīng)商提供相關(guān)測(cè)試報(bào)告/符合性證明書(shū)(ROHS,CA65)證明采購(gòu)物料的質(zhì)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?
(工廠是否清晰地定義來(lái)料的檢驗(yàn)狀態(tài), 正確區(qū)分出檢驗(yàn)合格, 待檢驗(yàn), 檢驗(yàn)不合格, 不同目標(biāo)市場(chǎng)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)
4.9、"Does factory clearly define and implement processes / authorities for disposition of nonconforming incoming goods, that could be RTV, rework & reinspect, approved concession?
(工廠是否清晰地定義并執(zhí)行來(lái)料不良品處理的流程/權(quán)限, 可能是退貨, 重工, 重檢驗(yàn), 批準(zhǔn)豁免)
4.10、"Does factory keep incoming inspection records and the relevant disposition records, that demonstrate effective execution of incoming inspection operation?
(工廠是否保存好來(lái)料檢驗(yàn)記錄和相關(guān)處理記錄, 證明工廠有效地執(zhí)行來(lái)料檢驗(yàn))
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?
(工廠的原物料/零件倉(cāng)是否有合適的儲(chǔ)存環(huán)境,正確的儲(chǔ)存和周轉(zhuǎn), 執(zhí)行先進(jìn)先出避免原物料/零件劣化或過(guò)期)
4.12、"Does factory identify products / materials properly with models,, item #, receiving dates, etc. to prevent unintended use of wrong quality materials /
products?
(工廠是否用模型,物料編號(hào),來(lái)料日期等正確地識(shí)別物料/產(chǎn)品, 避免非預(yù)期使用錯(cuò)誤的物料/產(chǎn)品.)
4.13、Does factory separate RoHS/REACH and non-RoHS/non-REACH goods properly in all storage areas?
(工廠是否嚴(yán)格地區(qū)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.?
(工廠是否正確地處理,運(yùn)送相關(guān)原料,零件和半成品而避免損壞和刮花等)、
4.15、"Does factory do regular stock taking, and control receiving and dispatching of inventories properly?
(工廠是否有周期性的庫(kù)存盤(pán)點(diǎn), 確保收發(fā)賬目的正確性)
Section 5: Production and In-process Quality Control (General Part)
(第五部分:生產(chǎn)和過(guò)程質(zhì)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?
(對(duì)于客戶(hù)訂單工廠是否有準(zhǔn)確的生產(chǎn)計(jì)劃, 考慮采購(gòu)和生產(chǎn)準(zhǔn)備時(shí)間, 可用產(chǎn)能等, 保持好的準(zhǔn)時(shí)交貨表現(xiàn).)"
5.2、"Does factory have a process plan for individual products, to outline manufacturing processes (incl. outsourced ones), identifying key process control points?
(工廠是否有流程計(jì)劃,概述出整個(gè)制造流程(包括外包流程), 識(shí)別出關(guān)鍵控制點(diǎn)
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?
(工廠是否正確地安排生產(chǎn), 恰當(dāng)?shù)胤峙湮锪?零件,設(shè)備,人力,過(guò)程檢驗(yàn)/測(cè)試等, 當(dāng)某工位產(chǎn)品質(zhì)量不能被后續(xù)檢驗(yàn)/測(cè)試證實(shí)時(shí),此工位必須是被驗(yàn)證過(guò)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?
(工廠是否準(zhǔn)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(biāo)準(zhǔn), 以及不良分類(lèi)等支持生產(chǎn)和檢驗(yàn)）
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?
(工廠生產(chǎn)/QC是否在過(guò)程和成品階段審核及簽發(fā)首件來(lái)保證產(chǎn)品滿(mǎn)足規(guī)格,質(zhì)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?
(在相關(guān)的生產(chǎn)制程,工廠是否應(yīng)用適當(dāng)?shù)墓ぱb夾具控制位置,方向,水平面,縫隙的一致性)
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(lái)確保質(zhì)量的達(dá)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(dá)到產(chǎn)品的正確質(zhì)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(dāng)?shù)膮⒖紭影?色版)去控制生產(chǎn)過(guò)程, 以達(dá)到產(chǎn)品結(jié)構(gòu)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?
(工廠是否適當(dāng)?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))
5.11、"Does factory have production lines and toolings solely dedicated for RoHS/REACH compliant
products
(工廠是否有單獨(dú)符合ROHS標(biāo)準(zhǔn),REACH標(biāo)準(zhǔn)的生產(chǎn)線和生產(chǎn)設(shè)備)
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?
(工廠是否有方法控制和預(yù)防物理,化學(xué)及生物污染等可能造成產(chǎn)品/人員的損壞)
5.13、"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(biāo)簽,包裝清單等)
5.14、Does factory identify products / components properly in production to prevent unintended use, where necessary, provide traceability?
(工廠是否正確地識(shí)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(shí)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.?
(工廠是否清晰地定義過(guò)程檢驗(yàn),包括檢驗(yàn)點(diǎn),檢驗(yàn)頻率/抽樣計(jì)劃,檢驗(yàn)和測(cè)試方法,檢驗(yàn)儀器,質(zhì)量要求及接收標(biāo)準(zhǔn))
5.16、"Does factory conduct in-process inspections according to the defined requirements, at appropriate stations, against the defined product spec., drawing, sample, etc.?
(工廠是否按照確定的要求進(jìn)行過(guò)程檢驗(yàn),包括檢驗(yàn)點(diǎn),確定的產(chǎn)品規(guī)格,圖紙,樣板等)
5.17、"Does factory record inspection results and findings, feedback / review with productions as
appropriate?
(工廠是否記錄檢驗(yàn)結(jié)果和發(fā)現(xiàn),并恰當(dāng)?shù)叵蛏a(chǎn)部門(mén)反饋)
5.18、"Does factory clearly identify inspection status of products in production lines, segregate
nonconforming products properly?
(工廠是否清晰地識(shí)別產(chǎn)品的檢驗(yàn)狀態(tài), 正確地區(qū)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(zhǔn)豁免)
Section 6: Final Inspection &Test
(第六部分:最終成品檢查及測(cè)試）
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(yàn)要求,特別是結(jié)構(gòu),表現(xiàn),安全和適用性等,定義檢驗(yàn)抽樣計(jì)劃和接收標(biāo)準(zhǔn))
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(xùn)QA/QC人員理解產(chǎn)品和檢驗(yàn)過(guò)程的質(zhì)量要求(檢驗(yàn)和測(cè)試項(xiàng)目,方法,測(cè)試設(shè)備,頻率,抽樣計(jì)劃,接收準(zhǔn)則等)
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.?
(工廠是否按照定義好的流程進(jìn)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(jìn)行足夠的測(cè)試去驗(yàn)證產(chǎn)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?
(工廠是否記錄終檢結(jié)果和發(fā)現(xiàn),并反饋給生產(chǎn)部門(mén)作為糾正和改善機(jī)會(huì))
6.5、"Does factory clearly identify inspection status of final products, segregate nonconforming products
properly?
(工廠是否清晰地識(shí)別檢驗(yàn)產(chǎn)品的狀態(tài), 隔離出不良品)
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(hù)的批準(zhǔn))
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?
(工廠是否有正確的出貨流程,確保產(chǎn)品通過(guò)終檢合格后才能出貨)
Section 7: Control of Measuring and Testing Equipment
(第七部分:計(jì)量和測(cè)試設(shè)備的控制)
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(cè)量?jī)x器,測(cè)量/測(cè)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 products, and test operations?
(工廠是否有測(cè)量/測(cè)試設(shè)備清單和校正計(jì)劃,包括生產(chǎn)使用/來(lái)料檢驗(yàn)/過(guò)程檢驗(yàn)/產(chǎn)品終檢以及測(cè)試階段的測(cè)量測(cè)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(dāng)?shù)臅r(shí)間間隔安排測(cè)量/測(cè)試設(shè)備的校正,以保證設(shè)備能恰當(dāng)和精確地驗(yàn)證產(chǎn)品,并且相關(guān)校正符合國(guó)家/國(guó)際標(biāo)準(zhǔn))
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(shí)別校正結(jié)果,有定義好的召回流程，當(dāng)發(fā)現(xiàn)測(cè)量/測(cè)試設(shè)備沒(méi)被校正好時(shí)執(zhí)行召回流程.)
Section 8: CAP and Continuous Improvement
(第八部分:改正措施計(jì)劃和持續(xù)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(jìn)/確認(rèn)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(hù)抱怨/退貨/投訴(包括客戶(hù)檢驗(yàn)和測(cè)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(dāng)生產(chǎn)中或供應(yīng)商產(chǎn)品有重大質(zhì)量問(wèn)題時(shí)工廠是否執(zhí)行或要求必要的糾正預(yù)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?
(工廠是否有一些必要的質(zhì)量數(shù)據(jù)收集和分析，以準(zhǔn)確的識(shí)別質(zhì)量問(wèn)題和改善機(jī)會(huì))"
8.5、Does factory initiate corrective actions and/or quality improvement projects based on quality data analysis?
(工廠是否基于質(zhì)量數(shù)據(jù)分析而啟動(dòng)一些糾正預(yù)防措施或質(zhì)量改善項(xiàng)目)
(質(zhì)量體系審核清單)
Section 1: Factory Facilities & Environment
(第一部分:工廠設(shè)施和環(huán)境)
/ repair areas, inspection, and packing areas?
(工廠整體是否干凈整齊:包括生產(chǎn)線,原料倉(cāng)和成品倉(cāng),重工返修區(qū),檢查和包裝區(qū)?)
1.2、"Does factory have sufficient lighting and ventilation in relevant working / storage areas?
(工廠在相關(guān)工作和儲(chǔ)存區(qū)域是否有足夠的光照和通風(fēng)?)
1.3、"Does factory maintain a suitable and secure environment for production and storage of products?
(工廠是否保持適宜的以及安全的產(chǎn)品生產(chǎn)和儲(chǔ)存環(huán)境?)
1.4、"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(jī)器和工裝用具)以及相應(yīng)的維護(hù)保養(yǎng)是否是好的狀態(tài)?)
1.5、"Does factory have and maintain sanitation and/or pest controls in certain production workshops and
/ or warehouses, as necessary?
(必要時(shí),工廠是否在特定的生產(chǎn)車(chē)間和倉(cāng)庫(kù)設(shè)立并執(zhí)行衛(wèi)生及蟲(chóng)害防治？)
Section 2: Quality System, Documentation Control, Training
(第二部分:質(zhì)量體系,文件管理,培訓(xùn))
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?
(工廠是否有文件化的質(zhì)量手冊(cè)去確定工廠的質(zhì)量方針,質(zhì)量目標(biāo),并且概述出高級(jí)別的質(zhì)量活動(dòng),
并且質(zhì)量方針相關(guān)內(nèi)容在內(nèi)部進(jìn)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(dá)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(jìn)行文件控制,像文件審核,批準(zhǔn),分發(fā),變更控制等?受控文件應(yīng)該包括外部標(biāo)準(zhǔn)文件;
內(nèi)部規(guī)格,圖紙,物料清單,標(biāo)準(zhǔn)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(shí)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(biāo)識(shí),保存環(huán)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?
(工廠是否有獨(dú)立的質(zhì)量部門(mén),
有授權(quán)的QA/QC人員檢驗(yàn)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 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?
(工廠是否很好地執(zhí)行全體員工及QA/QC人員培訓(xùn)體系,內(nèi)容包括產(chǎn)品知識(shí),生產(chǎn)流程,檢查和測(cè)試,正確的操作生產(chǎn)線和實(shí)驗(yàn)室的生
產(chǎn),計(jì)量和測(cè)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(duì)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(shí))
Section 3: Product Development Control
(第三部分:產(chǎn)品設(shè)計(jì)開(kāi)發(fā)控制)
3.1、Does factory have right knowledge, experiences and competent engineers / technicians to develop the type of products being sourced?
(工廠是否有正確的知識(shí),經(jīng)驗(yàn)和能勝任的工程師/技術(shù)員去開(kāi)發(fā)客戶(hù)需要的產(chǎn)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)?
(工廠是否了解不同市場(chǎng)例如美國(guó),加拿大,歐盟,日本等的法規(guī)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(hù)充分溝通,溝通開(kāi)發(fā)過(guò)程中的產(chǎn)品標(biāo)準(zhǔn),表現(xiàn),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.?
(工廠是否有詳細(xì)的開(kāi)發(fā)計(jì)劃去定義好以下開(kāi)發(fā)進(jìn)程，包括產(chǎn)品結(jié)構(gòu)/功能,需要的物料/零件,手板樣本制作,產(chǎn)品設(shè)計(jì)的審核/確認(rèn)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?
(工廠設(shè)計(jì)開(kāi)發(fā)階段是否有以下產(chǎn)出:更新且正確的產(chǎn)品規(guī)格,圖紙,樣板,并為生產(chǎn),采購(gòu),質(zhì)量控制提供相應(yīng)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?
(工廠是否有相應(yīng)的流程去管控產(chǎn)品/包裝變更, 包括通知客戶(hù)并得到客戶(hù)的批準(zhǔn))
3.7、"Does factory have competent engineer / technician who can develop, review / verify product package
contruction for the type of products?
(工廠是否有能勝任的工程師/技術(shù)員能開(kāi)發(fā),審核/確認(rèn)產(chǎn)品包裝結(jié)構(gòu))
3.8、Does factory have in-hosue 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(kāi)發(fā),審核/確認(rèn)用戶(hù)手冊(cè),裝配說(shuō)明書(shū)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?
(在量產(chǎn)前,工廠是否進(jìn)行正確的產(chǎn)品測(cè)試(或第三方測(cè)試)去確認(rèn)產(chǎn)品對(duì)于客戶(hù)要求和法規(guī)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?
(在量產(chǎn)前,工廠是否舉行產(chǎn)前會(huì)議交接產(chǎn)品質(zhì)量要求給生產(chǎn)部門(mén))
Section 4: Purchasing Control & Materials Control
(第四部分:采購(gòu)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?
(工廠是否有建立評(píng)估和選擇供應(yīng)商(包括分包商)的流程,基于供應(yīng)商滿(mǎn)足質(zhì)量和交貨方面要求的能力)
4.2、"Does factory have a method / process to evaluate and approve the materials / components before
purchase?
(在采購(gòu)之前工廠是否有方法/流程去評(píng)估和批準(zhǔn)原材料/零件)
4.3、"Does factory clearly communicate quality requirements to its suppliers when purchase materials or
outsource any production processes?
(當(dāng)采購(gòu)原物料或者外購(gòu)任何半成品時(shí)工廠是否清晰的與供應(yīng)商溝通其質(zhì)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
(工廠是否有評(píng)估供應(yīng)商質(zhì)量水平的機(jī)制去保證正確的供應(yīng)商穩(wěn)定地提供正確的物料/零件.)
4.5、"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(yàn)和測(cè)試要求, 包括抽樣計(jì)劃,檢驗(yàn)/測(cè)試內(nèi)容,收貨標(biāo)準(zhǔn)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?
(工廠是否按照定義的要求進(jìn)行原物料/零件的檢驗(yàn)/測(cè)試,
定義的要求包括受控的圖紙/標(biāo)準(zhǔn), 產(chǎn)品要求, 客戶(hù)樣板, 以及檢驗(yàn)/測(cè)試指導(dǎo)書(shū)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?
(當(dāng)工廠自己沒(méi)有能力檢驗(yàn)/測(cè)試時(shí),
是否要求供應(yīng)商提供相關(guān)測(cè)試報(bào)告/符合性證明書(shū)(ROHS,CA65)證明采購(gòu)物料的質(zhì)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?
(工廠是否清晰地定義來(lái)料的檢驗(yàn)狀態(tài), 正確區(qū)分出檢驗(yàn)合格, 待檢驗(yàn), 檢驗(yàn)不合格, 不同目標(biāo)市場(chǎng)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)
4.9、"Does factory clearly define and implement processes / authorities for disposition of nonconforming incoming goods, that could be RTV, rework & reinspect, approved concession?
(工廠是否清晰地定義并執(zhí)行來(lái)料不良品處理的流程/權(quán)限, 可能是退貨, 重工, 重檢驗(yàn), 批準(zhǔn)豁免)
4.10、"Does factory keep incoming inspection records and the relevant disposition records, that demonstrate effective execution of incoming inspection operation?
(工廠是否保存好來(lái)料檢驗(yàn)記錄和相關(guān)處理記錄, 證明工廠有效地執(zhí)行來(lái)料檢驗(yàn))
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?
(工廠的原物料/零件倉(cāng)是否有合適的儲(chǔ)存環(huán)境,正確的儲(chǔ)存和周轉(zhuǎn), 執(zhí)行先進(jìn)先出避免原物料/零件劣化或過(guò)期)
4.12、"Does factory identify products / materials properly with models,, item #, receiving dates, etc. to prevent unintended use of wrong quality materials /
products?
(工廠是否用模型,物料編號(hào),來(lái)料日期等正確地識(shí)別物料/產(chǎn)品, 避免非預(yù)期使用錯(cuò)誤的物料/產(chǎn)品.)
4.13、Does factory separate RoHS/REACH and non-RoHS/non-REACH goods properly in all storage areas?
(工廠是否嚴(yán)格地區(qū)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.?
(工廠是否正確地處理,運(yùn)送相關(guān)原料,零件和半成品而避免損壞和刮花等)、
4.15、"Does factory do regular stock taking, and control receiving and dispatching of inventories properly?
(工廠是否有周期性的庫(kù)存盤(pán)點(diǎn), 確保收發(fā)賬目的正確性)
Section 5: Production and In-process Quality Control (General Part)
(第五部分:生產(chǎn)和過(guò)程質(zhì)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?
(對(duì)于客戶(hù)訂單工廠是否有準(zhǔn)確的生產(chǎn)計(jì)劃, 考慮采購(gòu)和生產(chǎn)準(zhǔn)備時(shí)間, 可用產(chǎn)能等, 保持好的準(zhǔn)時(shí)交貨表現(xiàn).)"
5.2、"Does factory have a process plan for individual products, to outline manufacturing processes (incl. outsourced ones), identifying key process control points?
(工廠是否有流程計(jì)劃,概述出整個(gè)制造流程(包括外包流程), 識(shí)別出關(guān)鍵控制點(diǎn)
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?
(工廠是否正確地安排生產(chǎn), 恰當(dāng)?shù)胤峙湮锪?零件,設(shè)備,人力,過(guò)程檢驗(yàn)/測(cè)試等, 當(dāng)某工位產(chǎn)品質(zhì)量不能被后續(xù)檢驗(yàn)/測(cè)試證實(shí)時(shí),此工位必須是被驗(yàn)證過(guò)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?
(工廠是否準(zhǔn)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(biāo)準(zhǔn), 以及不良分類(lèi)等支持生產(chǎn)和檢驗(yàn)）
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?
(工廠生產(chǎn)/QC是否在過(guò)程和成品階段審核及簽發(fā)首件來(lái)保證產(chǎn)品滿(mǎn)足規(guī)格,質(zhì)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?
(在相關(guān)的生產(chǎn)制程,工廠是否應(yīng)用適當(dāng)?shù)墓ぱb夾具控制位置,方向,水平面,縫隙的一致性)
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(lái)確保質(zhì)量的達(dá)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(dá)到產(chǎn)品的正確質(zhì)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(dāng)?shù)膮⒖紭影?色版)去控制生產(chǎn)過(guò)程, 以達(dá)到產(chǎn)品結(jié)構(gòu)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?
(工廠是否適當(dāng)?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))
5.11、"Does factory have production lines and toolings solely dedicated for RoHS/REACH compliant
products
(工廠是否有單獨(dú)符合ROHS標(biāo)準(zhǔn),REACH標(biāo)準(zhǔn)的生產(chǎn)線和生產(chǎn)設(shè)備)
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?
(工廠是否有方法控制和預(yù)防物理,化學(xué)及生物污染等可能造成產(chǎn)品/人員的損壞)
5.13、"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(biāo)簽,包裝清單等)
5.14、Does factory identify products / components properly in production to prevent unintended use, where necessary, provide traceability?
(工廠是否正確地識(shí)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(shí)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.?
(工廠是否清晰地定義過(guò)程檢驗(yàn),包括檢驗(yàn)點(diǎn),檢驗(yàn)頻率/抽樣計(jì)劃,檢驗(yàn)和測(cè)試方法,檢驗(yàn)儀器,質(zhì)量要求及接收標(biāo)準(zhǔn))
5.16、"Does factory conduct in-process inspections according to the defined requirements, at appropriate stations, against the defined product spec., drawing, sample, etc.?
(工廠是否按照確定的要求進(jìn)行過(guò)程檢驗(yàn),包括檢驗(yàn)點(diǎn),確定的產(chǎn)品規(guī)格,圖紙,樣板等)
5.17、"Does factory record inspection results and findings, feedback / review with productions as
appropriate?
(工廠是否記錄檢驗(yàn)結(jié)果和發(fā)現(xiàn),并恰當(dāng)?shù)叵蛏a(chǎn)部門(mén)反饋)
5.18、"Does factory clearly identify inspection status of products in production lines, segregate
nonconforming products properly?
(工廠是否清晰地識(shí)別產(chǎn)品的檢驗(yàn)狀態(tài), 正確地區(qū)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(zhǔn)豁免)
Section 6: Final Inspection &Test
(第六部分:最終成品檢查及測(cè)試）
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(yàn)要求,特別是結(jié)構(gòu),表現(xiàn),安全和適用性等,定義檢驗(yàn)抽樣計(jì)劃和接收標(biāo)準(zhǔn))
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(xùn)QA/QC人員理解產(chǎn)品和檢驗(yàn)過(guò)程的質(zhì)量要求(檢驗(yàn)和測(cè)試項(xiàng)目,方法,測(cè)試設(shè)備,頻率,抽樣計(jì)劃,接收準(zhǔn)則等)
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.?
(工廠是否按照定義好的流程進(jìn)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(jìn)行足夠的測(cè)試去驗(yàn)證產(chǎn)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?
(工廠是否記錄終檢結(jié)果和發(fā)現(xiàn),并反饋給生產(chǎn)部門(mén)作為糾正和改善機(jī)會(huì))
6.5、"Does factory clearly identify inspection status of final products, segregate nonconforming products
properly?
(工廠是否清晰地識(shí)別檢驗(yàn)產(chǎn)品的狀態(tài), 隔離出不良品)
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(hù)的批準(zhǔn))
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?
(工廠是否有正確的出貨流程,確保產(chǎn)品通過(guò)終檢合格后才能出貨)
Section 7: Control of Measuring and Testing Equipment
(第七部分:計(jì)量和測(cè)試設(shè)備的控制)
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(cè)量?jī)x器,測(cè)量/測(cè)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 products, and test operations?
(工廠是否有測(cè)量/測(cè)試設(shè)備清單和校正計(jì)劃,包括生產(chǎn)使用/來(lái)料檢驗(yàn)/過(guò)程檢驗(yàn)/產(chǎn)品終檢以及測(cè)試階段的測(cè)量測(cè)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(dāng)?shù)臅r(shí)間間隔安排測(cè)量/測(cè)試設(shè)備的校正,以保證設(shè)備能恰當(dāng)和精確地驗(yàn)證產(chǎn)品,并且相關(guān)校正符合國(guó)家/國(guó)際標(biāo)準(zhǔn))
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(shí)別校正結(jié)果,有定義好的召回流程，當(dāng)發(fā)現(xiàn)測(cè)量/測(cè)試設(shè)備沒(méi)被校正好時(shí)執(zhí)行召回流程.)
Section 8: CAP and Continuous Improvement
(第八部分:改正措施計(jì)劃和持續(xù)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(jìn)/確認(rèn)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(hù)抱怨/退貨/投訴(包括客戶(hù)檢驗(yàn)和測(cè)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(dāng)生產(chǎn)中或供應(yīng)商產(chǎn)品有重大質(zhì)量問(wèn)題時(shí)工廠是否執(zhí)行或要求必要的糾正預(yù)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?
(工廠是否有一些必要的質(zhì)量數(shù)據(jù)收集和分析，以準(zhǔn)確的識(shí)別質(zhì)量問(wèn)題和改善機(jī)會(huì))"
8.5、Does factory initiate corrective actions and/or quality improvement projects based on quality data analysis?
(工廠是否基于質(zhì)量數(shù)據(jù)分析而啟動(dòng)一些糾正預(yù)防措施或質(zhì)量改善項(xiàng)目)
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