NUBY验厂咨询-NUBY供应商审核要点之从生产管理到风险评估的全面考量

NUBY 供应商审核要求
1. 目的 Purpose
清楚的列出 NUBY 对供应商审核的要求，使供应商和相关人员能够了解和遵循此审核的标准.
Define NUBY’s compliance audit to supplier and factory, to be ensure the fully understanding & implementation of NUBY Compliance Audit Requirement in regulation
2. 适用范围 Scope
 适用于 NUBY 对其供应商的审核要求.
 The definition is applying to the compliance audit to NUBY suppliers and factories.
3. 要求 Requirement
3.1A NUBY 审核要求
 NUBY Compliance Audit Requirement
3.1.1 原材料 Raw material
3.1.1.1 所有的原材料规格都应该形成文件.
 The raw materials shall be documented in specifications.
3.1.1.2 所有的原材料规格书应取得供应商确认.
 The raw material specifications are agreed with the supplier.
3.1.1.3 所有的原材料应具有 MSDS(化学原材料安全数据单)
 Material Safety Data Sheets are required for all chemical raw materials.
3.1.1.4 有显示符合规格书要求的记录.
 The factory shall have the records to show the compliance of the specification.
3.1.1.5 有不符合记录,并且有相对应纠正预防措施记录.
 The non-conformity shall be recorded and action taken as a result.
3.1.1.6 工厂需要对所有原材料供应商进行审核.
 All the mainly raw material suppliers shall be approved by the factory.
3.1.1.7 在所有原材料进入工厂前，都需要实施检验.
 Inspections are carried out on all raw materials entering the factory.
3.1.1.8 所有的原材料能够提供 COC.
 Certificates of Conformity (C of C) are supplied & supported for all raw materials.
3.1.1.9 原材料检验合格后才能发放到生产.
 The raw materials shall be approved and pass checked before release into production.
3.1.1.10 所有原材料批次应有清楚的识别.
 Batches of all raw materials can be clearly identified.
3.1.1.11 库存记录应清楚的显示批号，并遵循“先进先出”原则.
 The stock records clearly indicate the batch numbers and that shall be in accordance with the principle of “First In, First Out”.
3.1.1.12 不合格的原材料必须有清楚的识别.
 Non-conformity materials must be clearly identified.
3.1.1.13 不合格的原材料必须隔离在指定的区域.
 Non-conforming materials shall be segregated and in a nominated Quarantine Area.
3.1.1.14 所有的主要原材料不能被直接贮存在地上.
 The main raw materials shall be stored off the floor.
3.1.1.15 所有的原材料应有适当的防护，避免灰尘等污染.
 All raw materials shall be protected from dirt / contamination.
3.1.1.16 为所有原材料建立了一个文件化的库存控制系统.
 The factory shall be requested to have a documented stock control system/procedure for all raw materials.
3.1.1.17 所有的原材料和配件有一个合适的贮存环境,比如温度/湿度.
 The storage conditions shall be suitable for all the raw materials / components, e.g. Temperature / Humidity.
3.1.2 生产 Production
3.1.2.1 生产过程应合理地分成不同的阶段.
 The production process shall be broken down properly into stages.
3.1.2.2 生产人员能充分地理解相应的生产段.
 All the related stages shall be fully understood by production staff individually.
3.1.2.3 所有生产人员应能获取详细的工作指导.
Standard Operation Procedure or Work Instruction shall be detailed and available for all relevant personnel.
3.1.2.4 所有生产的产品都应有相应的产品技术文件支持.
 “Technical Files” shall be existed for all products produced at the site.
3.1.2.5 生产人员可即时获得正确的产品规格.
 Approved specifications shall be made available to production staff.
3.1.2.6 现场生产人员应可获得可供参考的批准样品.
 Approved product samples shall be available for use / reference.
3.1.2.7 每次生产结束时应进行现场清洁.
 A line clearance process shall be requested at the end of each production run.
3.1.2.8 工厂应建立程序来控制样品/规格书/技术文件的修改.
 The factory shall create an procedure to control any amendments to samples / specifications / technical files.
3.1.2.9 产品规格的修改必须得到客户的正式授权.
 Specification can't be amended without customer authorization.
3.1.2.10 生产中原材料的批号需清楚记录.
 Batch number of all raw materials shall be recorded for each production run.
3.1.2.11 持续生产应合理监控，以确保符合产品规格要求.
 Production shall be continuously monitored so as to against the product specification.
3.1.2.12 使用统计过程控制方法
 Statistical process control methods are introduced.
3.1.2.13 金属探测器须合理应用于生产线中.
 Metal detector shall be applied to the production line(Textile products).
3.1.2.14 所有的产品应清晰标识以确保其状态被清楚识别.
 All products shall be clearly labeled to identify its status.
3.1.2.15 所有的不符合的产品必须清晰标识和隔离.
 All non-conformity products must be clearly identified and segregated in stage.
3.1.2.16 工厂应建立利器控制程序.
 A sharp tool controlling procedure is introduced / applied to go through the whole production line.
3.1.2.17 工厂需建立断针控制程序.
 A broken needle policy shall be established for whole production line (where applicable).
3.1.2.18 所有机器和设备须定期维修保养.
 Regular maintenance shall be carried out on all machinery and equipment.
3.1.2.19 每台机器和设备的维修保养记录必须被保存.
 Maintenance records should be kept for each piece of machinery / equipment.
3.1.2.20 所有的新机器和设备投入生产之前都必须进行充分的测试与校验.
 All new machinery / equipment should be verified / calibrated before going into production.
3.1.2.21 所有的生产机器都应安装合适的安全防护装置(如果适用).
 All machines are requested to fit up with an appropriate safety guard(where it applicable).
3.1.2.22 所有的生产机器在合适的地方都需要安装安全停止装置.
 All machines are requested to fit up with the safety cut-out device(where it appropriate).
3.1.3 检验,测试和分析 Inspection, testing and analysis
3.1.3.1 现场与过程必须执行有效地检查.
 In-line / in-process inspections shall be carried out.
3.1.3.2 产品可有效追溯至整个生产过程.
 The product can be effective tracing back throughout the production process.
3.1.3.3 每次生产完成后,所有的生产记录必须有效的保存.
 All the production records shall be retained after each production run.
3.1.3.4 必须按产品质量收货标准实施产品的最终检验.
 The finished goods shall be inspected against to AQL.
3.1.3.5 在产品检验中正确运用统计抽样的方法.
 Statistical sampling method is introduced in the product inspection.
3.1.3.6 合格与不合格判定的标准应清晰的定义.
 Pass / fail criteria shall be clearly detailed.
3.1.3.7 所有的检验人员需获得合适的培训以确保他们能够有效的进行工作.
 All inspectors shall be trained and ensure the inspection is correct and efficient.
3.1.3.8 工厂需按实际产品建立实验室及相关测试.
 The factory is requested to establish an on-site testing facility to ensure the product is in consistency.
3.1.4 包装,贮存和分发 Packaging / storage and distribution
3.1.4.1 包装生产线需建立相应的产品包装规格.
 Packaging reference standard shall be available at the packing line.
3.1.4.2 产品包装应有相应的生产批号以便产品具有可追溯性.
 Batch codes shall be applied to the package to ensure the product is traceable.
3.1.4.3 建立适当的产品包装性能评测.
 Packaging performance tests is introduced to assess the suitability of the package.
3.1.4.4 工厂应建立专门的成品仓库.
 A Finished Goods Warehouse shall be set up on site.
3.1.4.5 成品仓库应干净、干燥、防风雨.
 The warehouse of the finished goods storage needs to be cleanly, drying and weather-proof.
3.1.4.6 成品必须清楚标识.
 The products should be identified clearly in the warehouse.
3.1.4.7 有先进先出程序.
The principle of “First In, First Out”(FIFO) is introduced to the finished goods storage.
3.1.4.8 有效记录货物进出仓库管理.
 The goods in and out shall be recorded in effective.
3.1.4.9 成品货物必须检验合格之后才可发送客户.
 The goods shall be released to customer under the pass inspection result.
3.1.5 风险评估和关键控制 Risk assessments and control (HACCP/FMEA)
3.1.5.1 工厂全体人员都需了解风险评估原则.
 Risk Management Principle shall be understood by all the factory employees.
3.1.5.2 工厂需建立一个正式的风险评估流程.
 The factory is requested to create a formal Risk Assessment Procedure.
3.1.5.3 风险评估中必须清楚的识别质量关键控制点.
 Critical Control Points(quality) shall be identified at the Risk Assessment Procedure. 
3.1.5.4 风险评估中必须清楚确认其通过或不通过的判定方法.
 The Risk Assessment shall be including the tolerance of the Pass and Fail.