FCCA Quality System Audit Outline FCCA質量體系審核綱要
(Hardline 雜貨)(Quality System part質量體系部分)
Factory Quality System工廠質量體系
1.0 Factory Facilities and Environment工廠設施和環境
1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas?
在生產，修理，加工，檢驗，包裝及裝載的區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，加工和包裝區域是否有秩序?
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工廠是否有單獨的檢驗區與檢驗臺并且通風良好?
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工廠是否有害蟲/霉菌和濕度的控制程序文件? 是否有經常巡查(公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.
在審核其間有沒有發現窗戶破損及房頂漏水可能導致產品污染。
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.
(嚴重) 工廠是否實行嚴格的利器控制程序，以防止剪刀、小刀、刀片、碎玻璃及針等混入產品中。
1.1 Machine Calibration and Maintenance機器校準和維護
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.
工廠的機器和設備是否清潔及運行良好。
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近的維護/校準日期及計劃日期的標識。
1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.
需要維修機器、設備和工具是否有維修標識以避免意外使用。
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，整潔的存儲區域儲存關鍵模具(比如:注射模具), 并且放在有標識的架子上。
1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.
工廠有適當的機器、工具、零部件和設備的庫存文件，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水平的保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質量管理體系
2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures.
工廠是否建立起符合他們產品和生產流程的質量管理體系。
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政策和目標。
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品召回程序。
2.0.4 (Critical) Factory QC team is independent from Production pision.
(嚴重) 工廠QC團隊是否獨立于生產部門。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)
是否有書面記錄顯示生產管理和QC團隊共同討論、解決質量問題及其他相關的問題.
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會影響產品或對人造成傷害的物理、化學和微生物污染風險。
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，以識別化學品、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.)?
工廠是否取得了國際的, 國家的或客戶的質量標準組織認證證書(例如: ISO 9001證書, 等.)?
3.0 Incoming Materials Control來料控制
3.0.1 Has the factory taken adequate measures to assure raw materials conformance to required specifications before use?
工廠是否檢測原物料以確認是否與要求的明細規格一致?
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、配件和部件的質量檢驗程序, 作業指導書, 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良好的狀態?
3.0.5 Are raw materials properly labeled, stored, and traceable?
所有的原物料是否有合適的標識, 儲存及可溯性？
3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.
工廠是否有文件程序和參考樣品以確保來料符合規格。
3.0.7 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.
(嚴重) 工廠是否建立起適當的物料控制體系, 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 rejects and identifies non-conforming (rejects) materials for replacement.
工廠是否分離良品與不良材料，并標識所需更換的不良材料。
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放并有標牌/標簽,且與地板隔離。
3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.
(嚴重) 化學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?
工廠是否有書面的供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)?
工廠是否跟蹤及評估物料供應商的可信度(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?
工廠是否建立起書面的對分包商的品質控制流程文件? 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過程和生產控制
4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?
產品設計和開發部門是否在產品設計及開發過程中研究與應用產品安全特性,評估樣式、模具和樣品？
4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.
工廠是否在每一個生產操作階段都有質量程序文件。
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) 在產前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錄采取的改進行動？
4.0.5 Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?
工廠是否進行“試生產”，根據產品規格明細檢討產品質量, 并記錄在生產前的糾正行動？
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部實驗室測試？(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?
是否有足夠的核準樣品、首件樣品、參考樣品和作業指導書提供給工人做適當的指引？
4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?
(嚴重) QC是否被授權當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.
在每一個操作過程是否由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.)
現行生產的產品質量是否可以接受? (檢查8個已檢驗的完成品是否有主要缺陷)
4.0.12 Factory QC inspects per standard AQL or as per industry standards.
工廠QC檢驗是否按照AQL抽樣檢驗標準或按照工業標準.
4.0.13 Factory performs 100% functionality check on final products?
工廠對最終產品有沒有實施100%功能性檢查?
4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)
工廠是否使用糾正措施和根本原因分析方法？(請提供例子)
4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?
工廠是否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 weather. 包裝紙箱是否儲存在封閉區域內, 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時出貨的表現？
5.0 In-House Lab-Testing內部實驗室測試
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.)
工廠是否執行內部實驗室測試和配備適當設施(請參考FCCA 內部實驗室測試要求的附頁)？
5.0.2 All gauges and test equipments have valid calibrations.
所有量規和測試設備是否有效校準。
5.0.3 Testing manuals of various industry standards are available as reference.
是否有各種行業標準測試手冊作為參考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.
內部實驗室的技術人員有沒有受過適當訓練來執行測試工作。
6.0 Final inspection最終檢驗
6.0.1 Does factory have procedure and working instruction for final QC?
工廠有沒有最終檢驗程序, 最終檢驗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QC 有沒有根據AQL抽樣檢驗標準或行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報告? 這些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?
工廠最終檢驗QC有沒有做一些機械測試以確保產品的安全性?
6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?
檢驗及測試的儀器設備是否使用良好且有校正?
6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(嚴重) 退貨的產品在客戶最終檢驗前有沒有得到適當糾正。
6.0.8 Factory does not ship goods unless subjected to release procedures from customer.
工廠有沒有程序控制只有當客戶同意的情況下才能出貨。
7.0 People Resources and Training人力資源和培訓
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) 工廠有沒有實施、記錄、保持對所有人員進行崗位培訓, 對技術工人在聘用前進行測試。
7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.
工廠有沒有對電氣/機械工程師、技師、檢驗員和實驗室測試技術員實施技術培訓，并保持記錄。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.
是否有保存所有人員的培訓記錄和個人表現記錄？