FCCA质量体系审核纲要(四)

4.0 Process and Production Control过程和生产控制
4.0.1  Does factory have work area only for Product Development? 工厂是否有产品开发工作区？
4.0.2  Does factory PD study and apply product safety features, evaluates patterns, moulds and samples during product design and development? 在产品设计和开发工厂产品开发的研究与应用是否有产品安全功能、评估模式、模具和样品？
4.0.3  Does Product development includes packaging design and tests that conforms to industry standard (ISTA) 产品开发包括包装设计和测试以确保符合行业标准(ISTA)。
4.0.4  Does factory PD perform assembly time-study on product and develop easy ways to use for consumer benefit? 工厂产品开发在产品执行组装时间研究，产品开发和简便的方法使用的消费者受益呢？
4.0.5  Factory has documented Production procedures at each stage of operation. 工厂有每一个阶段的运作生产程序文件。
4.0.6  Factory has documented Quality procedures at each stage of operation. 工厂有每一个阶段的运作质量程序文件。
4.0.7  Does factory conduct Pre-production meeting prior to start of production?工厂是否实施进行生产前的预产会议？
4.0.8  Are production and quality supervisors present during Pre-production meeting?目前在预产会议有生产和质量主管？
4.0.9  (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting? (重要)是至关重要的质量和安全检查、审查，确定，并采取行动加以改进记录在预产会议？
4.0.10  Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?工厂是否进行“试运行”，检讨对产品质量的规格表和文件在纠正行动之前生产？
4.0.11  Is quality of item acceptable on current production? (Check 3 or 4 completed products from production floor). 质量是可以接受的项目就目前的生产呢？(从生产区检查3或4个成品)。
4.0.12  Was in house lab-testing performed on current production? (Request for test copies)内部实验室测试是否实施当前生产测试？(要求测试的副本)
4.0.13  Does factory QC compare first piece samples with approval sample and specification sheet? 工厂QC是否比较首件样品抽样检验和批准的规格表？
4.0.14  Are there adequate approved samples, first piece samples, reference samples and work instructions to provide workers with proper guidelines? 是否有足够的核准样品、首件样品、参考样品和为工人提供适当的作业指导书？
4.0.15  Does factory use defective/ reject samples to demonstrate examples of common defects?
工厂使用有缺陷的/不合格样品是否普遍例子？
4.0.16  (Critical) Does Quality Control have authority to stop production if quality of products did not meet specification? (重要)如果产品质量不符合规格质量控制是否有权停止生产？
4.0.17  In-line inspections (IPQC) are performed by QC at every operation process. 在巡检(IPQC)所执行品管在每一个操作过程。
4.0.18  Does factory use statistical process control (SPC for quality)?工厂使用统计过程控制?(质量统计分析)
4.0.19  Factory QC inspects per standard AQL or as per industry standards.工厂品管检验按照标准AQL或按照工业标准.
4.0.20  Factory performs 100% functionality check on final products?工厂最终产品实施100%功能性确认?
4.0.21  Does factory use corrective actions and root cause analysis methods? (Please provide examples)工厂是否使用的纠正措施和根本原因分析方法呢？(请提供例子)
4.0.22 Does factory have guidelines in place to ensure packaging is correct for product? 工厂是否有指南以适当确保包装是正确的产品？
4.0.23  Does packing area have enough space to perform packing functions properly? Is it clean and organized? 包装区是否有足够的空间用来履行包装职能？它是清洁和有组织的？
4.0.24  Packed cartons are stored in enclosed area not exposed to sunshine and wet weather. 包装纸箱都储存在封闭区域内没有暴露于阳光和潮湿天气。
4.0.25  Does factory track and document on-time ship performance?工厂是否有跟踪和文件准时出货职能？
 
4.1 Suppliers and Sub-contractors供应商和分包商
4.1.1  Does factory have a documented supplier selection and approval process?工厂是否有供应商选择和批准过程文件?
4.1.2  Does factory track, evaluate and document material’s supplier reliability (performance)?工厂是否跟踪、评价和文件物料供应商的可靠性(效能) ？
4.1.3  Does factory have an established, documented quality procedure and does factory evaluate, monitor sub-contractor quality performance and reliability? 工厂是否有建立质量记录的程序和工厂评估、监测分包商的质量性能和可靠性呢？

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