TS16949 checklist - chinese - 图文

Item 7.5.18 Requirements What to look for Find what Judgement/ Remark Has the organization established and maintained ? a process for communication of information on service concerns to manufacturing, engineering ? and design activities? ? 组织是否建立并维持一个为售后服务问题的? 资讯与制造，工程和设计部门沟通的过程？ 7.5.1.8 Servicing agreement with customer/与顾客的服务协定 7.5.19 When there is a servicing agreement with the ? customer, does the organization verify the ? effectiveness of: ? - Any organization service centers? ? - Special purpose tools or measurement equipments? - Training of servicing personnel? Meeting reports, follow up and corrective actions/ responsibility/ dates. Product service data. 会议报告，跟踪活动和纠正措施/职业/日期。 产品售后服务资料。 Planning of periodical audits. Reports and follow up. 定期审核的规划。 报告和跟踪活动。 当与顾客达成售后服务协定时，组织是否验证以下活动的有效性： - 组织的任何一个售后服务中心。 - 特殊用途的工具或测量设备？ - 售后服务人员的培训？ 7.5.2 Validation of processes for production and service provision/生产和服务提供过程的确认 7.5.20 Does the organization validate any processes for ? Process validation/capability studies results. all its production and service provision where the ? Process parameters monitoring and control resulting output cannot be verified by subsequent evidence. monitoring or measurement? 当生产和售后服? 过程确认/能力研究的结果。 务提供过程的输出不能在后续进行监控或测? 过程参数监控和控制的证据 量而加以验证时，组织是否对任何这样的过程实施确认？ 7.5.21 Does the organization’s validation of processes ? for all its production and service provision ? demonstrate the ability of these processes to achieve planned results? 组织对这些所有的生产和售后服务提供过程的确认，是否证实这些过程可达成计划结果的能力？ Has the organization establish arrangements for ? Process validation/capability studies results. 过程确认/能力研究的结果。 7.5.22 Requirement specification for operations, Page 45 of 71

Item Requirements What to look for Find what Judgement/ Remark all its processes for production and service provision including, as applicable: Defined criteria for review and approval of the processes? Approval of equipment and qualification of personnel? Use of specific methods and procedures? Requirements for records? Revalidation? 组织是否制定对这些生产售后服务提供过程的安排，适用时包括： ａ）为这些过程的审查和批准所规定的准则。 ｂ）设备和人员资格的认可？ ｃ）使用规定的方法和程序？ ｄ）记录的要求？ ｅ）再确认？ 7.5.3 Identification and traceability/标识和可追溯性 7.5.23 Does the organization identify the product by suitable means throughout product realization? 组织是否在产品实现的整个过程中，使用适宜的方法识别产品？ ? ? ? ? ? equipment and personnel. Related records of qualification. Frequency and conditions of revalidation. 作业，设备和人员的要求规范。 和资格有关的记录。 再确认的频率和条件。 ? ? ? 7.5.24 7.5.25 Does the organization identify the product status with respect to monitoring and measurement requirements? 组织是否针对产品监控和测量要求，识别产品的状态？ Where traceability is a requirement, does the organization control and record the unique ? ? ? Clear identification of work in-process; finished goods and rejected goods and/or components. Inspection records. 清楚的标识过程中的工作，加工完成的产品，被拒绝的产品和/或元件。 ? Traceability system. ? 可追溯性。 Check for positive recall. Suitable product identification throughout the facility. Traceability from raw materials to delivered product. 主动召回的检查。 对整个工厂内合适的产品标识。 从原材料到交付产品的可追溯性。 Page 46 of 71

Item Requirements What to look for Find what Judgement/ Remark identification of the product. 在有可追溯性要求的时候，组织是否控制并记录产品的唯一性标识（见/ＩＳＯ16949：2002（Ｅ）要素4.2.4）？ 7.5.4 Customer property/顾客资产 7.5.26 Does the organization exercise care with customer property while it is under the organization’s control or being used by the organization? 组织是否照顾在组织控制下或组织使用中的顾客财产？ 7.5.27 Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? 组织是否识别，验证，保护和护卫供其使用或构成产品一部分的顾客财产？ 7.5.28 Does the organization report to the customer and maintain records for customer property that is list, damaged or otherwise found to be unsuitable for use? 若顾客资产发生遗失，损坏或发现不适用的情况时，组织是否报告顾客，并维持记录？ 7.5.4.1 customer owned tooling /顾客拥有的生产工具 7.5.29 Are the customer-owned tools, manufacturing, test, inspection tooling and equipment permanently marked so that the ownership of each item is visible, and can be determined? 顾客拥有的工装和制造，试验，检验的工具和设备是否有永久性标识，以使每一个工装设备的所属关系清晰可见，并可以被确定？ 7.5.5 Preservation of product/产品防护 7.5.30 Does the organization preserve the conformity of product during internal processing and delivery to the intended destination? 在内部加工和交付到预定的地点期间，组织是否针对产品的符合性提供防护？ 7.5.31 Does the organization’s preservation of product include identification, handling, packaging, ? ? Handling procedure of customer property. 顾客财产的处理程序。 ? ? ? ? ? ? ? ? Product identification. Storage environment. 产品识别 储存环境。 Damage to customer supplied product reports. What happened to customer owned returnable packaging? How was it accounted for? 顾客提供产品损坏的报告。 有无顾客拥有的可回收包装？如何处理它？ ? ? Permanent identification of tooling and equipment NA ownership. 工装和设备拥有权的永久性标识。 ? ? ? ? ? ? Procedure development and documentation. Plant tour. 程序的开发和文件。 参观工场。 Product preservation procedures. Plant tour. Page 47 of 71

Item Requirements What to look for Find what Judgement/ Remark storage and protection? 组织的产品防护是否包括标识，搬运，包装，储存和保护？ 7.5.32 Does the organization’s preservation of production apply to the constituent parts of a product? 组织的产品防护是否也应用于产品的组成部分？ 7.5.5.1 Storage and inventory/储存和库存 7.5.33 Does the organization assess the condition of product in stock at appropriate planned internals to detect deterioration? ? ? ? ? ? ? 产品保护的程序。 参观工场。 Scope product preservation procedures. Plant tour. 产品保护程序的范围。 参观工场。 7.5.34 7.5.35 ? ? ? 组织是否按适当计划的时间间隔来检查库存? 品状态，以便及时侦测变质情况？ ? ? Does the organization use an inventory ? management system to optimize inventory turns ? over time and assure stock rotation? ? 组织是否使用一库存管理系统，以优化库存? 周转期，确保货物财转？ ? ? Does the organization control obsolete product ? in a similar manner to nonconforming product? ? Storage product specifications. Inspection records. Plant tour. 产品存储规范。 检验记录。 参观工场。 Inventory management system . Evidence of FIFO. Control of obsolete product. 库存管理系统。 ＦＩＦＯ的证据。 废弃产品的控制。 Obsolete products stored in quarantine area. 废弃产品储存在隔离区域。 组织是否可以对待不合格品的类似方法，对废弃产品进行控制？ 7.6 control of monitoring and measuring devices/监控和测量装置的控制 7.6.1 Has the organization determined the monitoring ? Test equipment accuracy and precision capability and measurement to be undertaken and the related to the required measurement monitoring and measuring devices needed to ? 与需要的测量相关的试验设备准备度和精确度。 provide evidence of conformity of product to determined requirements? 组织是否确定了实施的监控和测量，以及为提供产品符合国确定的要求（见7.2.1）的证据所需的监控和测量装置？ 7.6.2 Has the organization established processes to ? Monitoring and measurement trials during prototype ensure that monitoring and measurement can be build. Page 48 of 71