FCCA Quality System Audit Outline
FCCA質量體系審核綱要
(Quality System part質量體系部分)
4.0 Process and Production Control過程和生產控制
4.0.1 Does factory have work area only for Product Development? 工廠是否有產品開發工作區？
4.0.2 Does factory PD study and apply product safety features, evaluates patterns, moulds and samples during product design and development? 在產品設計和開發工廠產品開發的研究與應用是否有產品安全功能、評估模式、模具和樣品？
4.0.3 Does Product development includes packaging design and tests that conforms to industry standard (ISTA) 產品開發包括包裝設計和測試以確保符合行業標準(ISTA)。
4.0.4 Does factory PD perform assembly time-study on product and develop easy ways to use for consumer benefit? 工廠產品開發在產品執行組裝時間研究，產品開發和簡便的方法使用的消費者受益呢？
4.0.5 Factory has documented Production procedures at each stage of operation. 工廠有每一個階段的運作生產程序文件。
4.0.6 Factory has documented Quality procedures at each stage of operation. 工廠有每一個階段的運作質量程序文件。
4.0.7 Does factory conduct Pre-production meeting prior to start of production?工廠是否實施進行生產前的預產會議？
4.0.8 Are production and quality supervisors present during Pre-production meeting?目前在預產會議有生產和質量主管？
4.0.9 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting? (重要)是至關重要的質量和安全檢查、審查，確定，并采取行動加以改進記錄在預產會議？
4.0.10 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“試運行”，檢討對產品質量的規格表和文件在糾正行動之前生產？
4.0.11 Is quality of item acceptable on current production? (Check 3 or 4 completed products from production floor). 質量是可以接受的項目就目前的生產呢？(從生產區檢查3或4個成品)。
4.0.12 Was in house lab-testing performed on current production? (Request for test copies)內部實驗室測試是否實施當前生產測試？(要求測試的副本)
4.0.13 Does factory QC compare first piece samples with approval sample and specification sheet? 工廠QC是否比較首件樣品抽樣檢驗和批準的規格表？
4.0.14 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、參考樣品和為工人提供適當的作業指導書？
4.0.15 Does factory use defective/ reject samples to demonstrate examples of common defects?
工廠使用有缺陷的/不合格樣品是否普遍例子？
4.0.16 (Critical) Does Quality Control have authority to stop production if quality of products did not meet specification? (重要)如果產品質量不符合規格質量控制是否有權停止生產？
4.0.17 In-line inspections (IPQC) are performed by QC at every operation process. 在巡檢(IPQC)所執行品管在每一個操作過程。
4.0.18 Does factory use statistical process control (SPC for quality)?工廠使用統計過程控制?(質量統計分析)
4.0.19 Factory QC inspects per standard AQL or as per industry standards.工廠品管檢驗按照標準AQL或按照工業標準.
4.0.20 Factory performs 100% functionality check on final products?工廠最終產品實施100%功能性確認?
4.0.21 Does factory use corrective actions and root cause analysis methods? (Please provide examples)工廠是否使用的糾正措施和根本原因分析方法呢？(請提供例子)
4.0.22 Does factory have guidelines in place to ensure packaging is correct for product? 工廠是否有指南以適當確保包裝是正確的產品？
4.0.23 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？它是清潔和有組織的？
4.0.24 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包裝紙箱都儲存在封閉區域內沒有暴露于陽光和潮濕天氣。
4.0.25 Does factory track and document on-time ship performance?工廠是否有跟蹤和文件準時出貨職能？
4.1 Suppliers and Sub-contractors供應商和分包商
4.1.1 Does factory have a documented supplier selection and approval process?工廠是否有供應商選擇和批準過程文件?
4.1.2 Does factory track, evaluate and document material’s supplier reliability (performance)?工廠是否跟蹤、評價和文件物料供應商的可靠性(效能) ？
4.1.3 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability? 工廠是否有建立質量記錄的程序和工廠評估、監測分包商的質量性能和可靠性呢？
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? 工廠是否執行內部實驗室測試和配備適當設施？
5.0.2 All gauges and test equipments have valid calibrations.所有量規和測試設備有效校準。
5.0.3 Testing manuals of various industry standards are available as reference.各種行業標準測試手冊是可作為參考。
5.0.4 In-house Lab Technicians are properly trained to perform testing functions. 在內部實驗室的技術人員受過適當訓練的執行測試功能。
6.0 Final inspection最終檢驗
6.0.1 Does factory QC performs final inspection and documents it?工廠QC是否執行最終檢驗和文件？
6.0.2 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC. 已核準的樣品或參考樣品與包裝清單和嘜頭，可作為工廠品管參考的。
6.0.3 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
(重要的)失效檢驗得到適當糾正在客戶最終檢驗。
6.0.4 Factory does not ship goods unless subjected to release procedures from customer.
工廠不出貨的貨物除非從客戶獲得豁免的程序。
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)工廠進行、文件、保持對在職培訓的所有人員或進行崗前技能培訓。
7.0.2 Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QA Auditor and Lab Test Technician. 工廠進行和文件的技術培訓計劃電動/機械工程師，機械師，質量保證審計員和實驗室測試技術員。
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained. 記錄學員及所有工作人員定期與相應的業績記錄，保存和維修保養。
Factory Quality System工廠的質量體系
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? 足夠的照明上：生產，返工，加工，檢驗，包裝及裝載的區域？
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
工廠保持清潔和有組織的生產，加工和包裝領域。
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
工廠有單獨的檢驗區與檢驗臺并且適當的通風設備。
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
工廠已記錄害蟲/霉菌和濕度的控制程序，其中包括經常巡查。(在公司內部或第三方)
1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit. 沒有打破窗戶或屋頂漏水，可能導致產品污染的觀察審核期間。
1.0.6 Factory has metal detecting unit. (Scoring will not apply (N/A) if factory does not need this machine.) 工廠有金屬檢測單位。
1.0.7 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses and needles to be mixed with product.
(重要)工廠實行嚴格的尖銳工具控制程序，以防止剪刀、刀、刀片、碎玻璃和針頭，以混合的產品。
1.0.8 Factory has back-up power supply available. “Generator” 工廠有后備電力供應。“發電機”
1.1 Machine Calibration and Maintenance機器校準和維護
1.1.1 Factory machines and equipments are appropriate to produce Wal-Mart products. 工廠的機器和設備是適合的生產沃爾瑪的產品。
1.1.2 Factory has documented system and procedure for scheduled equipment cleaning and repairs. 工廠有文件體系和程序，預定設備清洗和維修。
1.1.3 Factory machines and equipments appear to be clean and in good running condition.
工廠的機器和設備顯示是清潔和良好的運行狀態。
1.1.4 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule. 機器、設備和工具有適當的標識最后維修/校準日期及進度表。
1.1.5 Machines, equipments and tools that needs to be repaired are properly labeled to avoid accidental use. 機器、設備和工具需要維修時有標識以避免意外使用。
1.1.6 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves. 工廠有適當的，清潔的和有組織的存儲區域的關鍵模具(即注射模)與標識的貨架上。
1.1.7 Factory has proper documentation and updated inventory of machines, tools, spare parts and equipments. 工廠有適當的文件和更新庫存機器、工具、零部件和設備。
1.1.8 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines. 工廠維修團隊與合適的技術水平和設備，以履行必要的維修和校準的機器上。
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. 工廠建立適合產品和程序質量管理體系。
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives. 工人與主管所熟悉的這些質量的政策和目標。
2.0.3 Factory has documented customer complaint system and documented recall program. 工廠已記錄了顧客投訴體系，并記錄召回計劃。
2.0.4 (Critical) Factory QC team is independent from Production division. (重要)工廠QC團隊是獨立于生產部門。
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented) 生產管理和QC團隊討論和共同努力在解決質量問題/關注的問題。（記錄）
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. 工廠有制度和程序能控制物理、化學和生物污染風險，可能會損害產品和人員。
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments and tools. 工廠進行風險評估，以識別危險化學品、原材料、工藝設備和工具。
3.0 Incoming Materials Control進料控制
3.0.1 Proper first in-first out (FIFO) system on materials are practiced.物料實施先進先出(FIFO)體系。
3.0.2 Factory has procedures for quality inspection on incoming raw materials, accessories and components. 工廠有對進倉原物料、配件和部件質量檢驗的程序。
3.0.3 Incoming and outgoing material quantities are monitored and documented. 進料和出貨的物料的數量進行監測和記錄。
3.2.4 Factory has specifications for purchased materials. 工廠有采購物料規范。
3.2.5 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications. 工廠有文件程序和參考樣品以確保進倉原料符合規格。
3.2.6 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items. (重要)工廠已適當的對物料隔離體系，不合格的項目隔離以避免意外污染，
3.2.7 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement. 工廠適當隔離良品(不良品)，并確定不良品(拒絕)更換。
3.2.8 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding. 廠房的存儲區域周圍有足夠的照明、通風和清潔。
3.0.9 Materials, components and accessories are properly stacked and identified with tags / labels and off the floor. 材料、部件和配件的妥善堆放并有標記/標簽并與地板隔離。
3.0.10 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination. (重要)化學品和維修的物質妥善標識和儲存，以防止污染的風險。
3.0.11 Color relevant materials such as fabrics, genuine leather and synthetic PU/ PVC, trims and accessories are sorted by lot numbers. 顏色有關的材料如布料、真皮及合成聚氨酯/聚氯乙烯、裝飾及配件按批號儲存。