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FCCA Quality System Audit Outline
(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?
1.0.2 The facility maintains clean and organized production, finishing and packing areas.
1.0.3 Facility has separate inspection area with inspection table and proper ventilation.
1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)
1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit.
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.
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.
1.1.2 Factory machines and equipments appear to be clean and in good running condition.
1.1.3 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.
1.1.4 Machines, equipments and tools that need to be repaired are properly labeled to avoid accidental use.
1.1.5 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves.
1.1.6 Factory has proper documentation and updated inventory of machines, tools, spare parts, and equipments.
1.1.7 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines.
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.
2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.
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 division.
2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)
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.
2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments, and tools.
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?
3.0.2 Proper first in-first out (FIFO) system on materials are practiced.
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?
3.0.5 Are raw materials properly labeled, stored, and traceable?
3.0.6 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications.
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.
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.
3.0.11 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.
3.0.12 Does factory have a documented supplier selection and approval process?
3.0.13 Does factory track, evaluate and document material's supplier reliability (performance)?
3.0.14 Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability?
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?
4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.
4.0.3 Does factory conduct Pre-production meeting prior to start of production?
4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?
4.0.5 Does factory conduct "pilot-run", review product quality against specification sheet and document results with corrective actions prior to production?
4.0.6 Was in house lab-testing performed on current production? (Request for test copies)
4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?
4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?
4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?
4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.
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.)
4.0.12 Factory QC inspects per standard AQL or as per industry standards.
4.0.13 Factory performs 100% functionality check on final products?
4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)
4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?
4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?
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?
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.)
5.0.2 All gauges and test equipments have valid calibrations.
5.0.3 Testing manuals of various industry standards are available as reference.
5.0.4 In-house Lab Technicians are properly trained to perform testing functions.
6.0 Final inspection最終檢驗
6.0.1 Does factory have procedure and working instruction for final QC?
6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.
6.0.3 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.
6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?
6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?
6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?
6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.
6.0.8 Factory does not ship goods unless subjected to release procedures from customer.
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.
7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.