生產(chǎn)能力評估概括

1、FCCA生產(chǎn)能力評估概括1.0 Factory Facilities and Environment工廠基礎(chǔ)設(shè)施和生產(chǎn)環(huán)境 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas? 在生產(chǎn)，修理，加工，檢驗(yàn)，包裝及裝載的區(qū)域是否有足夠的照明？1.0.2 The facility maintains clean and organized production, finishing and packing areas.工廠是否保持清潔,在生產(chǎn)，加

2、工和包裝區(qū)域是否有秩序?1.0.3 Facility has separate inspection area with inspection table and proper ventilation. 工廠是否有單獨(dú)的檢驗(yàn)區(qū)與檢驗(yàn)臺并且通風(fēng)良好?1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party) 工廠是否有害蟲/霉菌和濕度的控制程序文件? 是否有經(jīng)常巡查(公司內(nèi)部或第三方檢查)?

3、1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit.在審核其間有沒有發(fā)現(xiàn)窗戶破損及房頂漏水可能導(dǎo)致產(chǎn)品污染。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.

4、(嚴(yán)重) 工廠是否實(shí)行嚴(yán)格的利器控制程序，以防止剪刀、小刀、刀片、碎玻璃及針等混入產(chǎn)品中。1.1 Machine Calibration and Maintenance機(jī)器設(shè)備校準(zhǔn)和維護(hù)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系統(tǒng)和程序計(jì)劃安排設(shè)備的清潔及維修。1.1.2 Factory machines and equipments appear to be clean and in good running condit

5、ion. 工廠的機(jī)器和設(shè)備是否清潔及運(yùn)行良好。1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule. 機(jī)器、設(shè)備和工具是否有最近的維護(hù)/校準(zhǔn)日期及計(jì)劃日期的標(biāo)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(jī)器、設(shè)備和工具是否有維修標(biāo)識以避免意外使

6、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(dāng)，整潔的存儲區(qū)域儲存關(guān)鍵模具(比如:注射模具), 并且放在有標(biāo)識的架子上。1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments. 工廠有適當(dāng)?shù)臋C(jī)器、工具、零部件和設(shè)備的

7、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. 工廠是否擁有一定技術(shù)水平的保養(yǎng)團(tuán)隊(duì)和設(shè)備可以執(zhí)行必要的機(jī)器維修和校準(zhǔn)的工作。2.0 Quality Management System質(zhì)量管理控制體系2.0.1 Factory has established Quality Management System that is appropriate to th

8、eir products and procedures. 工廠是否建立起符合他們產(chǎn)品和生產(chǎn)流程的質(zhì)量管理控制體系。2.0.2 Workers & Supervisors are familiar to these quality policies and objectives. 工人與主管是否熟悉這些品質(zhì)政策和目標(biāo)。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(chǎn)品召回程序。2.0.4 (Critical) Factory QC te

9、am is independent from Production division. (嚴(yán)重) 工廠QC團(tuán)隊(duì)是否獨(dú)立于生產(chǎn)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(chǎn)管理和QC團(tuán)隊(duì)共同討論、解決質(zhì)量問題及其他相關(guān)的問題.2.0.6 Factory has systems and procedures in place to control the risk of physical

10、, chemical, and biological contamination that may damage the product and personnel as well. 工廠是否有系統(tǒng)和程序去控制那些可能會影響產(chǎn)品或?qū)θ嗽斐蓚Φ奈锢?、化學(xué)和微生物污染風(fēng)險(xiǎn)。2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools. 工廠是否進(jìn)行風(fēng)險(xiǎn)評估，以識別化學(xué)品、原材料、工藝設(shè)備和工具中帶來的危害。2.0.8

11、Is factory accredited with any international, national or customer quality standards association (e.g. ISO 9001, etc.)?工廠是否取得了國際的, 國家的或客戶的質(zhì)量標(biāo)準(zhǔn)組織認(rèn)證證書(例如: ISO 9001證書, 等.)?3.0 Incoming Materials Control來料過程控制3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required s

12、pecifications before use?工廠是否檢測原物料以確認(rèn)是否與要求的明細(xì)規(guī)格一致?3.0.2 Proper first in-first out (FIFO) system on materials are practiced.工廠是否實(shí)施物料先進(jìn)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 component

13、s. 工廠是否有進(jìn)倉原物料、配件和部件的質(zhì)量檢驗(yàn)程序, 作業(yè)指導(dǎo)書, 及記錄文件。3.0.4 Is needed testing equipment available, and maintained in good condition?所需的來料測試儀器是否配備及保持在一個(gè)良好的狀態(tài)?3.0.5 Are raw materials properly labeled, stored, and traceable? 所有的原物料是否有合適的標(biāo)識, 儲存及可溯性？3.0.6 Factory has documented process and reference samples that ensu

14、re incoming raw materials conform to specifications. 工廠是否有文件程序和參考樣品以確保來料符合規(guī)格。3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items. (嚴(yán)重) 工廠是否建立起適當(dāng)?shù)奈锪峡刂企w系, 以隔離不合格的原材料及避免意外污染?3.0.8 Factory properly separate good quality items from reje

15、cts and identifies non-conforming (rejects) materials for replacement. 工廠是否分離良品與不良材料，并標(biāo)識所需更換的不良材料。3.0.9 Facilitys storage areas have sufficient lighting, well ventilated and clean surrounding. 廠房的存儲區(qū)域是否有足夠的照明、通風(fēng)和清潔。3.0.10 Materials, components, and accessories are properly stacked and identified wit

16、h tags / labels and off the floor. 材料、部件和配件是否妥善堆放并有標(biāo)牌/標(biāo)簽,且與地板隔離。3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination. (嚴(yán)重) 化學(xué)品和保養(yǎng)的物質(zhì)是否妥善標(biāo)識和儲存，以防止污染的風(fēng)險(xiǎn)。3.0.12 Does factory have a documented supplier selection and approval process? 工廠是否

17、有書面的供應(yīng)商的的選用和認(rèn)可流程?3.0.13 Does factory track, evaluate and document materials supplier reliability (performance)? 工廠是否跟蹤及評估物料供應(yīng)商的可信度(表現(xiàn))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? 工廠是

18、否建立起書面的對分包商的品質(zhì)控制流程文件? 是否有評估及監(jiān)督分包商的品質(zhì)表現(xiàn)及信賴度?4.0 Process and Production Control工序和生產(chǎn)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(chǎn)品設(shè)計(jì)和開發(fā)部門是否在產(chǎn)品設(shè)計(jì)及開發(fā)過程中研究與應(yīng)用產(chǎn)品安全特性,評估樣式、模具和樣品？4.0.2 Factory has documented

19、Quality procedures (QP) at each stage of operation. 工廠是否在每一個(gè)生產(chǎn)操作階段都有質(zhì)量程序文件。4.0.3 Does factory conduct Pre-production meeting prior to start of production?工廠在生產(chǎn)前是否進(jìn)行產(chǎn)前會議？4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-pro

20、duction meeting? (嚴(yán)重) 在產(chǎn)前會議中有沒有審查及確認(rèn)嚴(yán)重的質(zhì)量問題和安全問題并記錄采取的改進(jìn)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?工廠是否進(jìn)行“試生產(chǎn)”，根據(jù)產(chǎn)品規(guī)格明細(xì)檢討產(chǎn)品質(zhì)量, 并記錄在生產(chǎn)前的糾正行動？4.0.6 Was in house lab-testing performed on

21、current production? (Request for test copies)當(dāng)前生產(chǎn)有沒有實(shí)施內(nèi)部實(shí)驗(yàn)室測試？(要求測試記錄副本)4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet? 工廠QC是否根據(jù)客戶簽樣和產(chǎn)品規(guī)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 t

22、o provide workers with proper guidelines? 是否有足夠的核準(zhǔn)樣品、首件樣品、參考樣品和作業(yè)指導(dǎo)書提供給工人做適當(dāng)?shù)闹敢?.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification? (嚴(yán)重) QC是否被授權(quán)當(dāng)產(chǎn)品質(zhì)量不符合規(guī)格時(shí)是否有權(quán)停止生產(chǎn)？4.0.10 In-line inspections (IPQC) are performed by QC at every ope

23、ration process. 在每一個(gè)操作過程是否由QC 執(zhí)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(xiàn)行生產(chǎn)的產(chǎn)品質(zhì)量是否可以接受? (檢查8個(gè)已檢驗(yàn)的完成品是否有主要缺陷)4.0.12 Factory QC inspects per standard AQL or as per

24、 industry standards.工廠QC檢驗(yàn)是否按照AQL抽樣檢驗(yàn)標(biāo)準(zhǔn)或按照工業(yè)標(biāo)準(zhǔn).4.0.13 Factory performs 100% functionality check on final products?工廠對最終產(chǎn)品有沒有實(shí)施100%功能性檢查?4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)工廠是否使用糾正措施和根本原因分析方法？(請?zhí)峁├?4.0.15 Does factory have guidelines

25、in place to ensure packaging is correct for product? 工廠是否有工作指引以確保產(chǎn)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(qū)是否有足夠的空間用來履行包裝職能？是否清潔和有秩序？4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weathe

26、r. 包裝紙箱是否儲存在封閉區(qū)域內(nèi), 沒有暴露于陽光和潮濕天氣。4.0.18 Does factory track and document on-time ship performance?工廠是否有跟蹤和記錄準(zhǔn)時(shí)出貨的表現(xiàn)？5.0 In-House Lab-Testing內(nèi)部實(shí)驗(yàn)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

27、requirements.)工廠是否執(zhí)行內(nèi)部實(shí)驗(yàn)室測試和配備適當(dāng)設(shè)施(請參考FCCA 內(nèi)部實(shí)驗(yàn)室測試要求的附頁)？5.0.2 All gauges and test equipments have valid calibrations.所有量規(guī)和測試設(shè)備是否有效校準(zhǔn)。5.0.3 Testing manuals of various industry standards are available as reference.是否有各種行業(yè)標(biāo)準(zhǔn)測試手冊作為參考。5.0.4 In-house Lab Technicians are properly trained to perform testin

28、g functions. 內(nèi)部實(shí)驗(yàn)室的技術(shù)人員有沒有受過適當(dāng)訓(xùn)練來執(zhí)行測試工作。6.0 Final inspection最終檢驗(yàn)6.0.1 Does factory have procedure and working instruction for final QC?工廠有沒有最終檢驗(yàn)程序, 最終檢驗(yàn)QC有沒有工作指導(dǎo)書？6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards. 工廠QC 有沒有根據(jù)AQL抽樣檢驗(yàn)標(biāo)準(zhǔn)或行業(yè)標(biāo)準(zhǔn)來實(shí)施最終檢驗(yàn)。6.0.3 An approv

29、ed sample or reference sample with packing list and shipping marks are available as reference for factory QC. 最終檢驗(yàn)QC有沒有客戶簽樣或參考樣品, 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? 有沒有正式的最終檢驗(yàn)報(bào)告? 這些報(bào)告是否歸檔及可追蹤產(chǎn)品質(zhì)量?6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of produc