1.0 Factory Facilities and Environment工廠基礎設施(shi)和生產(chan)環(huan)境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas?
在(zai)生產，修(xiu)理(li)，加工，檢驗(yan)，包裝及裝載的區域是否有(you)足夠的照明？
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
工廠是否保持清潔(jie),在生產(chan)，加工(gong)和包裝(zhuang)區域是否有(you)秩序?
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工(gong)廠是否有單獨的(de)檢驗(yan)區與檢驗(yan)臺并且通風良(liang)好?
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工廠(chang)是否有害(hai)蟲/霉菌和(he)濕度(du)的控制(zhi)程序文件? 是否有經常巡查(公(gong)司內部或第三方檢查)?
1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit.
在審核其間有(you)(you)沒有(you)(you)發現窗戶破損及房頂漏水可能導(dao)致產品污(wu)染。
1.0.6 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses, and needles to be mixed with product.
(嚴重) 工廠是否實行嚴格(ge)的利(li)器控制(zhi)程序，以防止(zhi)剪刀(dao)、小刀(dao)、刀(dao)片、碎(sui)玻璃及針等混入產品中(zhong)。
1.1 Machine Calibration and Maintenance機器(qi)設備校準和(he)維護
1.1.1 Factory has documented system and procedure for scheduled equipment cleaning and repairs.
工廠是否有書面的(de)文件(jian)系統和程(cheng)序(xu)計劃安排設備的(de)清(qing)潔及(ji)維(wei)修。
1.1.2 Factory machines and equipments appear to be clean and in good running condition.
工廠的機器和設備是(shi)否清(qing)潔及運行良好。
1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.
機器、設備和工具是否有最(zui)近的維護/校(xiao)準日期及計劃(hua)日期的標識。
1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.
需要維(wei)修(xiu)機器、設(she)備和(he)工(gong)具是否有維(wei)修(xiu)標識以避免意(yi)外使用。
1.1.5 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves.
工廠是(shi)否有適(shi)當，整潔(jie)的存儲(chu)區域儲(chu)存關鍵模具(ju)(比如(ru):注射(she)模具(ju)), 并且放在有標(biao)識的(de)架子(zi)上。
1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.
工廠有(you)適(shi)當(dang)的(de)機器、工具、零部件和設備的(de)庫存文件，并保持更新。
1.1.7 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines.
工廠(chang)是否擁(yong)有一定(ding)技術水平的保養團(tuan)隊和(he)設備可以(yi)執行必(bi)要的機器維(wei)修和(he)校準(zhun)的工作。
2.0 Quality Management System質量(liang)管理控(kong)制體(ti)系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.
工廠(chang)是否(fou)建(jian)立(li)起符(fu)合他們產(chan)品和生(sheng)產(chan)流(liu)程的質量管理控(kong)制體系。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.
工人與主管是否(fou)熟悉(xi)這些(xie)品質政策和目(mu)標。
2.0.3 Factory has documented customer complaint system and documented recall program. 工廠是否建立了顧客(ke)投訴體系及產品召回程序。
2.0.4 (Critical) Factory QC team is independent from Production division.
(嚴(yan)重) 工(gong)廠QC團隊是(shi)否獨立(li)于生(sheng)產部門(men)。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)
是否有(you)書面記錄顯(xian)示生產管理和(he)QC團隊(dui)共同討論、解決質量問(wen)(wen)題及其他相(xiang)關的問(wen)(wen)題.
2.0.6 Factory has systems and procedures in place to control the risk of physical, chemical, and biological contamination that may damage the product and personnel as well.
工廠是否有(you)系統(tong)和程序去控制那些可能會影響(xiang)產品或對人造成傷害的物理、化學(xue)和微生物污(wu)染風(feng)險(xian)。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.
工(gong)廠(chang)是否進行風險評估，以識別化學品、原材料、工(gong)藝設(she)備和(he)工(gong)具中帶(dai)來(lai)的(de)危(wei)害。
2.0.8 Is factory accredited with any international, national or customer quality standards association (e.g. ISO 9001, etc.)?
工廠(chang)是(shi)否取得了國際的, 國(guo)家的(de)或客戶的(de)質量(liang)標準組織認證證書(shu)(例(li)如: ISO 9001證書, 等.)?
3.0 Incoming Materials Control來料過(guo)程控制
3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required specifications before use?
工廠是(shi)否檢測原物料以確認是(shi)否與要求的明(ming)細(xi)規格(ge)一致?
3.0.2 Proper first in-first out (FIFO) system on materials are practiced.
工廠(chang)是(shi)否實(shi)施物(wu)料先進先出(FIFO)體系。
3.0.3 Factory has procedures (instructions, guidelines, and documented records) for quality inspection on incoming raw materials, accessories, and components.
工廠(chang)是否有進(jin)倉(cang)原物料、配件和(he)部(bu)件的(de)質量檢(jian)驗程序, 作業指導(dao)書(shu), 及記錄文件。
3.0.4 Is needed testing equipment available, and maintained in good condition?
所(suo)需的(de)來料測試儀(yi)器是否配備及保(bao)持在(zai)一個良(liang)好的(de)狀態?
3.0.5 Are raw materials properly labeled, stored, and traceable?
所有的原(yuan)物料是否有合(he)適的標識, 儲存(cun)及可溯(su)性？
3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.
工廠是否有文件(jian)程序和參考樣品以確保(bao)來料符合規格。
3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.
(嚴重) 工廠是否(fou)建立起適當(dang)的物(wu)料(liao)控制體(ti)系, 以隔離不合(he)格的原材料及避免(mian)意外(wai)污(wu)染?
3.0.8 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.
工廠是(shi)否(fou)分離良品與(yu)不(bu)良材料(liao)，并(bing)標識所需(xu)更換(huan)的(de)不(bu)良材料(liao)。
3.0.9 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠房的存儲區域是否有足夠的照明、通風和清(qing)潔。
3.0.10 Materials, components, and accessories are properly stacked and identified with tags / labels and off the floor.
材料、部件和配件是否妥善堆(dui)放(fang)并有標牌(pai)/標(biao)簽,且(qie)與地板隔離。
3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.
(嚴重) 化(hua)學品和(he)(he)保(bao)養的(de)物質是否(fou)妥善標識和(he)(he)儲存，以防止污染的(de)風險(xian)。
3.0.12 Does factory have a documented supplier selection and approval process?
工廠是否有(you)書面的(de)供應(ying)商的(de)的(de)選用(yong)和認(ren)可流程?
3.0.13 Does factory track, evaluate and document material’s supplier reliability (performance)?
工(gong)廠是(shi)否跟蹤及(ji)評估物料供應商的可信度(表(biao)現)并(bing)記錄在案?
3.0.14 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?
工廠(chang)是否建立起(qi)書面的(de)對分包商的(de)品(pin)質控制流程文件(jian)? 是否有評估及監督分包商的品質表現及信賴度?
4.0 Process and Production Control工(gong)序和(he)生產(chan)控制
4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?
產(chan)品設計和開發部門(men)是否在(zai)產(chan)品設計及開發過程中研究(jiu)與應用產(chan)品安全特性,評估(gu)樣式、模具和(he)樣品？
4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.
工(gong)廠是否在(zai)每(mei)一(yi)個生產操作階段都有質(zhi)量程(cheng)序(xu)文件。
4.0.3 Does factory conduct Pre-production meeting prior to start of production?
工廠在生產前(qian)是否(fou)進行產前(qian)會議？
4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?
(嚴重) 在產前會議中有沒有審查及(ji)確認嚴重的質量(liang)問題和安(an)全問題并記(ji)錄采(cai)取的改(gai)進行(xing)動(dong)？
4.0.5 Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?
工廠是否進行(xing)“試生產(chan)”，根據產品(pin)規格(ge)明細檢討產品(pin)質(zhi)量, 并記錄在(zai)生產前的糾正行動？
4.0.6 Was in house lab-testing performed on current production? (Request for test copies)
當前生產有沒有實施內(nei)部實驗室測試？(要求(qiu)測試記(ji)錄副本)
4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?
工(gong)廠QC是否(fou)根據客戶簽樣和產品規格(ge)表(biao)來(lai)制定首件(jian)樣品？
4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?
是(shi)否(fou)有足夠的核準(zhun)樣(yang)品、首件樣(yang)品、參考(kao)樣(yang)品和作業(ye)指導(dao)書提供(gong)給工人做適(shi)當的指引？
4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?
(嚴重) QC是否被(bei)授權當(dang)產品質量不符合規格時是否有權停止生產？
4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.
在(zai)每一(yi)個(ge)操(cao)作過程是否由QC 執行巡檢(IPQC)。
4.0.11 Is quality of item acceptable on current production? (Check 8 finished products taken from factory final inspected goods and check for major defects on the item.)
現行生(sheng)產的產品質量(liang)是否可以接受(shou)? (檢(jian)查8個(ge)已(yi)檢驗的完成品是否有(you)主(zhu)要缺陷)
4.0.12 Factory QC inspects per standard AQL or as per industry standards.
工(gong)廠QC檢驗是否按照AQL抽樣檢驗標準(zhun)或(huo)按(an)照(zhao)工業標準(zhun).
4.0.13 Factory performs 100% functionality check on final products?
工廠對最終產(chan)品有沒有實施100%功能性檢查?
4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)
工(gong)廠是否使用糾正措施和根(gen)本原因分(fen)析(xi)方法(fa)？(請(qing)提供例(li)子)
4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?
工廠是(shi)否有工作指引以確(que)保產品(pin)包裝(zhuang)是(shi)正(zheng)確(que)的？
4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?
包裝區是(shi)否(fou)有(you)足夠的(de)空間用來履行包裝職能？是(shi)否(fou)清潔(jie)和有(you)秩序？
4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包裝紙(zhi)箱是否(fou)儲存在封閉區域內, 沒有暴露(lu)于陽(yang)光(guang)和潮濕天氣。
4.0.18 Does factory track and document on-time ship performance?
工廠是否有跟蹤和記錄準時出(chu)貨的表現？
5.0 In-House Lab-Testing內(nei)部實驗室測試審核
5.0.1 Does factory perform in-house lab testing and are facilities appropriately equipped? (Please refer to the FCCA attachment for in-house lab testing requirements.)
工廠是否(fou)執(zhi)行內(nei)部(bu)實驗室測試(shi)和配備適當設施(請參考FCCA 內部實(shi)驗室測試要求的附頁)？
5.0.2 All gauges and test equipments have valid calibrations.
所有量(liang)規和測試設備是(shi)否有效校準。
5.0.3 Testing manuals of various industry standards are available as reference.
是否有各種行業標(biao)準測試(shi)手冊作為參考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.
內部(bu)實驗室(shi)的技術人員有沒有受(shou)過適當訓(xun)練來執(zhi)行測試(shi)工(gong)作。
6.0 Final inspection最終檢(jian)驗
6.0.1 Does factory have procedure and working instruction for final QC?
工廠(chang)有沒有最終檢(jian)驗程序, 最終檢(jian)驗QC有沒有工作指導書？
6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.
工廠(chang)QC 有沒有根據AQL抽樣檢驗標準或行(xing)業標準來實施最終檢驗。
6.0.3 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.
最終檢驗QC有沒有客戶簽樣或參考樣品, 包裝清(qing)單以及出貨(huo)嘜頭作參考.
6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?
有沒有正式(shi)的最(zui)終檢驗報告(gao)? 這些(xie)報告是否歸檔及可追蹤產品質量?
6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?
工廠最終檢(jian)驗QC有沒有做一些機械測試以確保產(chan)品的安全性?
6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?
檢驗(yan)及測試的儀器設備(bei)是否使用良(liang)好且有(you)校正?
6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(嚴重) 退貨(huo)的產品(pin)在客戶最終檢驗前(qian)有(you)沒有(you)得(de)到適(shi)當糾正。
6.0.8 Factory does not ship goods unless subjected to release procedures from customer.
工廠(chang)有沒有程序控制只有當客戶(hu)同意(yi)的情況下才能出貨。
7.0 People Resources and Training人力資源(yuan)招聘和培訓
7.0.1 (Critical) Factory conducts, documents, maintains on-job training for all personnel, or conducts pre-hire testing of skilled workers prior to hiring.
(重要) 工廠有(you)沒有(you)實施、記(ji)錄、保持對所有(you)人員進行崗位(wei)培(pei)訓, 對技(ji)術工人(ren)在聘用前進行測試。
7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.
工廠有(you)沒有(you)對電氣(qi)/機械工(gong)程(cheng)師(shi)、技師(shi)、檢驗(yan)員和實驗(yan)室(shi)測試(shi)技術(shu)員實施技術(shu)培訓，并保持(chi)記錄(lu)。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.
是(shi)否(fou)有保存所有人(ren)員的(de)培(pei)訓記錄和個人(ren)表(biao)現記錄。
微信咨詢
E-mail
