FCCA生產能力評估概括
1.0 Factory Facilities and Environment工廠基(ji)礎設(she)施和生(sheng)產環境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas?
在生產，修理，加工，檢(jian)驗，包裝及裝載(zai)的區(qu)域(yu)是(shi)否有足夠的照明？
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
工廠是否保(bao)持清(qing)潔,在生產，加工和包裝區域是(shi)否有(you)秩序?
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工廠(chang)是否有單獨的(de)檢(jian)驗區與(yu)檢(jian)驗臺(tai)并且通風良好?
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工(gong)廠是否有害蟲/霉菌和濕度的控制程序文(wen)件(jian)? 是(shi)否有經常(chang)巡查(公司內部或第(di)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)沒有(you)發現(xian)窗戶(hu)破(po)損(sun)及房頂漏水可能導致產品污(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(yan)重) 工廠是否實行(xing)嚴(yan)格的利器控制(zhi)程序，以防止剪刀(dao)、小刀(dao)、刀(dao)片、碎玻璃及針等混入產(chan)品中。
1.1 Machine Calibration and Maintenance機(ji)器(qi)設備校準和(he)維護(hu)
1.1.1 Factory has documented system and procedure for scheduled equipment cleaning and repairs.
工廠是否有(you)書(shu)面的文件系(xi)統(tong)和程序計劃安排設備的清(qing)潔(jie)及(ji)維修。
1.1.2 Factory machines and equipments appear to be clean and in good running condition.
工(gong)廠的機器和設備是否清潔及運行良好(hao)。
1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.
機(ji)器、設備和工具(ju)是否有最(zui)近的維護/校準日(ri)期(qi)及計劃日(ri)期(qi)的標識。
1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.
需要維修機器、設備和工具是否有(you)維修標識以避(bi)免(mian)意外使用。
1.1.5 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves.
工廠(chang)是否有適當(dang)，整潔(jie)的存儲(chu)區域儲(chu)存關鍵(jian)模具(比如(ru):注射模具), 并(bing)且放在(zai)有(you)標識的架子上(shang)。
1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.
工(gong)廠有適當的機(ji)器、工(gong)具、零部件和設備的庫存(cun)文件，并保持更(geng)新。
1.1.7 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines.
工廠是否擁有一定技術(shu)水平的保(bao)養團隊和設備可以執行必要的機器維修和校準的工作。
2.0 Quality Management System質量管(guan)理控制體系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.
工廠是否(fou)建立起符合他們產(chan)品和生(sheng)產(chan)流程的質量管理控制體系。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.
工人與主(zhu)管是否熟悉這些品質政策和目標。
2.0.3 Factory has documented customer complaint system and documented recall program. 工(gong)廠是否(fou)建立了(le)顧客投(tou)訴體系及(ji)產品召回程序(xu)。
2.0.4 (Critical) Factory QC team is independent from Production division.
(嚴重) 工廠QC團(tuan)隊是否獨立(li)于生產部門。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)
是否有書面記錄顯示生產管(guan)理(li)和QC團隊共同討論、解決質量(liang)問(wen)題及(ji)其他(ta)相關的問(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.
工廠是否有系統和程序去控制那些可能(neng)會影響(xiang)產品或對人造成(cheng)傷(shang)害的物理(li)、化(hua)學和微(wei)生物污染風險。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.
工廠是否進行(xing)風險評估，以識別化(hua)學品、原材料、工藝設備和工具中帶來(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(gong)廠是否(fou)取得了國際(ji)的, 國家(jia)的(de)或客戶(hu)的(de)質(zhi)量標(biao)準組織認證(zheng)證(zheng)書(例如: ISO 9001證書, 等.)?
3.0 Incoming Materials Control來(lai)料過程控(kong)制
3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required specifications before use?
工(gong)廠是否檢測原物料以確認是否與要(yao)求的(de)明細規格一致?
3.0.2 Proper first in-first out (FIFO) system on materials are practiced.
工廠(chang)是(shi)否實施物料先進先出(FIFO)體系。
3.0.3 Factory has procedures (instructions, guidelines, and documented records) for quality inspection on incoming raw materials, accessories, and components.
工廠是否有進倉原物料、配件和部(bu)件的質量檢驗程序(xu), 作業指導(dao)書, 及記錄(lu)文件。
3.0.4 Is needed testing equipment available, and maintained in good condition?
所需的來(lai)料測試儀器是(shi)否配備及保持在一個良好的狀態?
3.0.5 Are raw materials properly labeled, stored, and traceable?
所有的原(yuan)物料是否有合適(shi)的標識, 儲存及可溯(su)性？
3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.
工廠是否(fou)有文件程序和參考樣品以確保來料符(fu)合規格。
3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.
(嚴重) 工(gong)廠是(shi)否建立(li)起適當的物料(liao)控制體(ti)系(xi), 以隔離不(bu)合(he)格的原材料及(ji)避免意外污染?
3.0.8 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.
工廠是(shi)否分離良品與(yu)不(bu)良材料(liao)，并標識所需更換的(de)不(bu)良材料(liao)。
3.0.9 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠(chang)房的(de)(de)存儲區域是否(fou)有足夠的(de)(de)照明、通風和清潔。
3.0.10 Materials, components, and accessories are properly stacked and identified with tags / labels and off the floor.
材(cai)料、部件和配件是否妥(tuo)善堆放并有標牌/標簽,且與(yu)地(di)板隔離。
3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.
(嚴重(zhong)) 化學(xue)品和保養的物質是否妥善標識和儲存，以防止污染的風險。
3.0.12 Does factory have a documented supplier selection and approval process?
工廠是否有書(shu)面(mian)的供應商的的選(xuan)用和認可(ke)流(liu)程(cheng)?
3.0.13 Does factory track, evaluate and document material’s supplier reliability (performance)?
工廠是否(fou)跟蹤及評估物料供應商的可(ke)信度(表現(xian))并記錄(lu)在(zai)案?
3.0.14 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?
工廠是(shi)否建(jian)立起書面的對分包(bao)商的品質控(kong)制流程文件? 是否有評估及監督分包商的品質表現(xian)及信賴(lai)度?
4.0 Process and Production Control工序(xu)和(he)生產控制
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(pin)設計和開發部門是否在產(chan)品(pin)設計及開發過程中(zhong)研究與應(ying)用產(chan)品(pin)安全特性,評估樣(yang)式、模具和樣(yang)品？
4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.
工廠是否(fou)在每一個生產操作階段都有(you)質量程序(xu)文件。
4.0.3 Does factory conduct Pre-production meeting prior to start of production?
工(gong)廠在生產(chan)前是否進行產(chan)前會議？
4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?
(嚴(yan)重) 在產前會(hui)議中有(you)沒有(you)審查及(ji)確認嚴重的(de)質量問題和安(an)全問題并記錄采取的(de)改進(jin)行動？
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(fou)進行“試生產(chan)”，根據產(chan)品規格明細(xi)檢(jian)討產(chan)品質(zhi)量, 并記錄(lu)在生(sheng)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(qian)生產(chan)有沒有實(shi)施(shi)內部實(shi)驗室測試？(要求(qiu)測試記錄(lu)副本)
4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?
工廠(chang)QC是(shi)否根據客戶簽樣和產品(pin)規格表來制定(ding)首件(jian)樣品(pin)？
4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?
是否有(you)足夠的核準樣(yang)品(pin)(pin)、首件樣(yang)品(pin)(pin)、參考(kao)樣(yang)品(pin)(pin)和作業指(zhi)導書提供給工(gong)人做適當(dang)的指(zhi)引？
4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?
(嚴重(zhong)) QC是(shi)否(fou)被授權(quan)當(dang)產品質量不符合規格時是(shi)否(fou)有權(quan)停止生(sheng)產？
4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.
在每一(yi)個(ge)操作過程是否由QC 執(zhi)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(xian)行生(sheng)產的產品質量是否可以接受? (檢查(cha)8個已檢驗的完成(cheng)品是(shi)否有主要缺陷)
4.0.12 Factory QC inspects per standard AQL or as per industry standards.
工廠QC檢驗(yan)是(shi)否按照(zhao)AQL抽樣檢驗標準(zhun)(zhun)或(huo)按照(zhao)工業標準(zhun)(zhun).
4.0.13 Factory performs 100% functionality check on final products?
工廠對最終產品(pin)有(you)沒有(you)實施(shi)100%功能性檢查?
4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)
工廠(chang)是否使用糾(jiu)正(zheng)措施(shi)和根(gen)本原因(yin)分(fen)析方法(fa)？(請提(ti)供(gong)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(zuo)指引以確保產品包(bao)裝(zhuang)是(shi)正確的？
4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?
包(bao)裝區是(shi)否有(you)(you)足夠的(de)空間用來履行包(bao)裝職能？是(shi)否清(qing)潔和有(you)(you)秩(zhi)序？
4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包(bao)裝(zhuang)紙箱(xiang)是否(fou)儲存在封閉區域內, 沒有暴露于(yu)陽光和潮濕天氣(qi)。
4.0.18 Does factory track and document on-time ship performance?
工(gong)廠是(shi)否有跟蹤和記錄準(zhun)時出(chu)貨的表(biao)現？
5.0 In-House Lab-Testing內部實驗室測試(shi)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)執行內部實驗室測(ce)試(shi)和配備適當(dang)設施(請參考FCCA 內部(bu)實驗室測(ce)試要求的附頁)？
5.0.2 All gauges and test equipments have valid calibrations.
所有(you)量(liang)規和測試(shi)設備是否有(you)效校準(zhun)。
5.0.3 Testing manuals of various industry standards are available as reference.
是否有各種(zhong)行(xing)業標準測試(shi)手冊作為(wei)參(can)考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.
內(nei)部實驗室的(de)技術人員有沒(mei)有受過適當訓(xun)練來執行測試(shi)工作。
6.0 Final inspection最終(zhong)檢驗
6.0.1 Does factory have procedure and working instruction for final QC?
工廠有沒有最終檢驗程(cheng)序, 最終(zhong)檢驗QC有沒有工(gong)作指(zhi)導書？
6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.
工廠QC 有沒(mei)有根據(ju)AQL抽(chou)樣檢驗(yan)標準或行業標準來實施最終檢驗(yan)。
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(ke)戶簽樣或(huo)參考樣品(pin), 包(bao)裝清單以及出貨嘜頭作(zuo)參考.
6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?
有沒有正式的最終檢驗報(bao)告? 這些報告是否歸檔及可追(zhui)蹤產品(pin)質量?
6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?
工廠最終(zhong)檢驗QC有沒(mei)有做一些(xie)機(ji)械(xie)測試以確(que)保產(chan)品的安全性(xing)?
6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?
檢(jian)驗及測試的(de)儀器設備是否使用良好(hao)且有校正?
6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(嚴重(zhong)) 退貨的產品在(zai)客戶最終檢驗前有沒有得(de)到適(shi)當糾正。
6.0.8 Factory does not ship goods unless subjected to release procedures from customer.
工(gong)廠(chang)有(you)沒有(you)程序控(kong)制只有(you)當客戶同意的情(qing)況(kuang)下(xia)才能出貨。
7.0 People Resources and Training人力資(zi)源(yuan)招聘(pin)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(zhong)要(yao)) 工廠(chang)有沒有實施(shi)、記錄、保持對所(suo)有人(ren)員進行崗(gang)位(wei)培(pei)訓, 對(dui)技術工人在聘用(yong)前(qian)進行測(ce)試。
7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.
工廠(chang)有沒(mei)有對電氣(qi)/機械工程師、技師、檢驗員(yuan)和實(shi)驗室測試技術員(yuan)實(shi)施技術培訓，并保持(chi)記(ji)錄。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.
是否有保存所有人(ren)員的培訓(xun)記錄和(he)個人(ren)表(biao)現記錄。
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