FCCA生產能力評估概括
1.0 Factory Facilities and Environment工廠(chang)基礎設施和(he)生產環境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas?
在(zai)生產，修理，加工，檢驗，包(bao)裝(zhuang)及裝(zhuang)載的區(qu)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(shi)否保持清潔,在生產，加工和包裝區(qu)域是否(fou)有秩序(xu)?
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工廠是否(fou)有單獨的檢驗區(qu)與檢驗臺并且通風(feng)良好?
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工廠是否有(you)害蟲(chong)/霉菌和濕度的控制程序文件? 是否有經常巡查(公司內部或(huo)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(shen)核其間有沒有發現窗戶破損及(ji)房頂漏水可能導致(zhi)產品(pin)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(zhong)) 工廠是否(fou)實行嚴格的利器(qi)控(kong)制程(cheng)序(xu)，以防止剪刀、小刀、刀片、碎(sui)玻璃及針等混入產品中。
1.1 Machine Calibration and Maintenance機(ji)器設備校(xiao)準和維護
1.1.1 Factory has documented system and procedure for scheduled equipment cleaning and repairs.
工廠是否有書面的文件(jian)系統和程序計劃安排設備的清潔及維修。
1.1.2 Factory machines and equipments appear to be clean and in good running condition.
工廠的機器和(he)設備是否清潔及(ji)運(yun)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(hu)/校準日期及計劃(hua)日期的(de)標(biao)識。
1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.
需(xu)要維修機器、設備和工具是否有(you)維修標識以避免(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.
工廠是否有適當(dang)，整(zheng)潔的(de)存(cun)儲區域儲存(cun)關鍵模具(比如:注射模(mo)具), 并且放(fang)在有標識(shi)的架子上。
1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.
工廠有適當的機器、工具(ju)、零部件(jian)和設備的庫存文(wen)件(jian)，并(bing)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(gong)廠是否擁有(you)一定(ding)技術水平的保養團(tuan)隊(dui)和設備可(ke)以執行必要的機器維修和校準的工(gong)作。
2.0 Quality Management System質量管理(li)控(kong)制體系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.
工廠(chang)是否建(jian)立起符合他們產品和生(sheng)產流(liu)程的質量管理控制體(ti)系(xi)。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.
工人與(yu)主管是(shi)否熟悉這些品質政策和目(mu)標(biao)。
2.0.3 Factory has documented customer complaint system and documented recall program. 工廠是否建立了顧客投訴體系及產(chan)品召(zhao)回程序。
2.0.4 (Critical) Factory QC team is independent from Production division.
(嚴重) 工廠QC團(tuan)隊是否(fou)獨(du)立于生產部門。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)
是否有書面記(ji)錄顯示生產管(guan)理和QC團(tuan)隊共同討論(lun)、解決質量問(wen)題及其他(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(fou)有(you)系統和(he)程序去控制那些可能會影響產品或對人造成傷害的物理、化學和(he)微生物污染風險。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.
工廠是否進行風險評估，以(yi)識(shi)別(bie)化學(xue)品、原材料、工藝設備和工具中帶來的危害。
2.0.8 Is factory accredited with any international, national or customer quality standards association (e.g. ISO 9001, etc.)?
工廠是否取得(de)了國(guo)際的, 國(guo)家的(de)或客(ke)戶的(de)質量標準組織認證證書(shu)(例如: ISO 9001證書, 等(deng).)?
3.0 Incoming Materials Control來(lai)料過程控制
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(yao)求的明細規格一致?
3.0.2 Proper first in-first out (FIFO) system on materials are practiced.
工廠是否實施物料先(xian)進先(xian)出(FIFO)體(ti)系(xi)。
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(you)進倉(cang)原物料、配(pei)件和部件的質量(liang)檢(jian)驗程序, 作業指導書, 及記(ji)錄(lu)文(wen)件。
3.0.4 Is needed testing equipment available, and maintained in good condition?
所需的來料(liao)測試儀器是否配備(bei)及(ji)保持(chi)在一個良好的狀態?
3.0.5 Are raw materials properly labeled, stored, and traceable?
所(suo)有(you)(you)的原物料(liao)是否有(you)(you)合(he)適(shi)的標識, 儲(chu)存及可溯性？
3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.
工廠(chang)是否有文(wen)件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(yan)重) 工廠是否(fou)建立起適當(dang)的(de)物料控制體系, 以隔離不合格的(de)原材料(liao)及避(bi)免意外污染(ran)?
3.0.8 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement.
工廠是否分(fen)離良品與不良材料，并標識所(suo)需更(geng)換(huan)的不良材料。
3.0.9 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠(chang)房的存儲區域(yu)是否有足夠的照明、通風(feng)和(he)清潔(jie)。
3.0.10 Materials, components, and accessories are properly stacked and identified with tags / labels and off the floor.
材料、部件和(he)配件是否妥善(shan)堆放并有標(biao)牌(pai)/標(biao)簽(qian),且與地(di)板(ban)隔離。
3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.
(嚴重) 化學品和(he)保養的物(wu)質是否妥(tuo)善標識和(he)儲存，以防止污染(ran)的風(feng)險。
3.0.12 Does factory have a documented supplier selection and approval process?
工廠是否有書面的供(gong)應商的的選用和認可流程?
3.0.13 Does factory track, evaluate and document material’s supplier reliability (performance)?
工廠是否跟蹤及(ji)評估物料供應商(shang)的可信度(表現)并記錄在案?
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(shu)面的(de)對分包商的(de)品質控(kong)制流程文件? 是否有(you)評估(gu)及監督分包商的品質表現及信賴(lai)度?
4.0 Process and Production Control工序和生產控制
4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?
產品設計和開(kai)發(fa)部門是否在產品設計及開(kai)發(fa)過程中(zhong)研究(jiu)與應(ying)用產品安全特性,評(ping)估樣式、模(mo)具和樣品(pin)？
4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.
工廠(chang)是否在每一個生產(chan)操作階段都有(you)質量程(cheng)序文件。
4.0.3 Does factory conduct Pre-production meeting prior to start of production?
工廠在生產前是否進(jin)行產前會議？
4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?
(嚴重(zhong)) 在產前(qian)會議中有沒有審查及確認嚴重的質量問題和安全問題并記(ji)錄采取的改(gai)進(jin)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(shi)否進行(xing)“試生產”，根(gen)據(ju)產品規格明細檢討(tao)產品質量, 并記錄在生產前的糾(jiu)正行動(dong)？
4.0.6 Was in house lab-testing performed on current production? (Request for test copies)
當(dang)前(qian)生產有(you)沒有(you)實施內部實驗室測(ce)試？(要求(qiu)測試記錄副本)
4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?
工(gong)廠QC是否根據客戶簽樣和產品規格表來制定首件樣品？
4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?
是(shi)否有足夠的核準樣品(pin)、首件樣品(pin)、參考樣品(pin)和作業指導書提(ti)供給工(gong)人做(zuo)適當的指引？
4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?
(嚴(yan)重(zhong)) QC是否被授權當產品質量不符合規格時是否有權停(ting)止生(sheng)產？
4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.
在每一(yi)個操作過程是(shi)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.)
現行生產的產品質(zhi)量是否可以接受(shou)? (檢查8個(ge)已(yi)檢驗的完成品(pin)是否有主(zhu)要缺陷)
4.0.12 Factory QC inspects per standard AQL or as per industry standards.
工廠QC檢驗是否按照AQL抽樣(yang)檢驗標準或按照工業標準.
4.0.13 Factory performs 100% functionality check on final products?
工廠對(dui)最(zui)終產品有沒(mei)有實(shi)施100%功能性(xing)檢(jian)查?
4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)
工廠是否使(shi)用糾(jiu)正措施和(he)根本(ben)原因分析(xi)方法？(請(qing)提供(gong)例子(zi))
4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?
工廠是否(fou)有工作指引以確保產品包裝是正確的？
4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?
包裝區是否(fou)有足(zu)夠的空間用來履(lv)行包裝職能？是否(fou)清潔和有秩序？
4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包裝紙箱是否儲存在封閉區域內(nei), 沒有暴(bao)露于陽光(guang)和潮濕天氣。
4.0.18 Does factory track and document on-time ship performance?
工廠是(shi)否有跟蹤和記錄準時出貨的表現？
5.0 In-House Lab-Testing內部實驗室測試審核
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(shi)否(fou)執(zhi)行內部實驗(yan)室(shi)測(ce)試和配備適當設施(shi)(請參考FCCA 內部(bu)實(shi)驗(yan)室測試要求的附(fu)頁)？
5.0.2 All gauges and test equipments have valid calibrations.
所有量(liang)規和(he)測試設備是否有效校(xiao)準。
5.0.3 Testing manuals of various industry standards are available as reference.
是(shi)否有各種行(xing)業(ye)標(biao)準測試(shi)手冊作(zuo)為參考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.
內部實驗室的技(ji)術人員有沒有受過(guo)適當訓練(lian)來執行(xing)測試工作(zuo)。
6.0 Final inspection最終檢驗
6.0.1 Does factory have procedure and working instruction for final QC?
工廠有沒有最(zui)終檢驗程序, 最終檢驗(yan)QC有沒有工作指(zhi)導書？
6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.
工(gong)廠QC 有(you)沒(mei)有(you)根(gen)據(ju)AQL抽樣檢驗標(biao)準(zhun)或行業標(biao)準(zhun)來實施最終(zhong)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(zhong)檢驗QC有沒有客(ke)戶簽樣或參(can)考樣品, 包裝清單以及出貨嘜頭作參考.
6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?
有沒有正式的最終(zhong)檢驗報(bao)告(gao)? 這些報告是否歸檔及可追(zhui)蹤產品質量?
6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?
工廠最終檢驗QC有沒有做一(yi)些機械測試(shi)以確保(bao)產(chan)品(pin)的(de)安全性?
6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?
檢驗及測試的儀器(qi)設備是否使(shi)用良(liang)好且(qie)有校(xiao)正?
6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(嚴(yan)重) 退貨(huo)的產品在客戶最(zui)終檢(jian)驗(yan)前有(you)沒有(you)得到(dao)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(mei)有程(cheng)序(xu)控(kong)制只有當客(ke)戶同(tong)意的情(qing)況下才(cai)能出貨。
7.0 People Resources and Training人力(li)資源招聘(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) 工廠(chang)有(you)沒有(you)實施(shi)、記錄(lu)、保持對所有(you)人員進行崗位(wei)培訓, 對技(ji)術工人在聘(pin)用前進行(xing)測(ce)試(shi)。
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/機械(xie)工程師、技師、檢驗(yan)員(yuan)和實驗(yan)室(shi)測試技術員(yuan)實施技術培訓，并保持記錄。
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)員的培訓記錄(lu)和個人(ren)表(biao)現記錄(lu)。
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