FCCA品質體系審核綱要(四)

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式檔。
4.0.6  Factory has documented Quality procedures at each stage of operation. 工廠有每一個階段的運作品質程式檔。
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品質主管？
4.0.9  (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting? (重要)是至關重要的品質和安全檢查、審查，確定，並採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”，檢討對產品品質的規格表和檔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). 品質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核對總和批准的規格表？
4.0.14  Are there adequate approved samples, first piece samples, reference samples and work instructions to provide workers with proper guidelines? 是否有足夠的核准樣品、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)如果產品品質不符合規格品質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)?工廠使用統計程序控制?(品質統計分析)
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?工廠是否有跟蹤和檔準時出貨職能？
 
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准過程檔?
4.1.2  Does factory track, evaluate and document material’s supplier reliability (performance)?工廠是否跟蹤、評價和檔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? 工廠是否有建立品質記錄的程式和工廠評估、監測分包商的品質性能和可靠性呢？