过程审核指南（中英文）.doc

过程审核指南 Process Audit Guide 1.目的 Purpose： 对产品的制造过程进行审核，确定产品的制造过程及所涉及的活动在质量方面是否满足策划的安排，以及这些安排是否有效贯彻。加强对过程的控制、监督，采取预防、纠正、持续改进等措施，使过程能在一些干扰因素的影响下仍能稳定受控，提高制造过程的稳定性和有效性以及能力。 To audit the manufacture process of product， to determine that manufacture process of product and its related actions is met the planed schedule at quality aspect. To strengthen the control and supervision of process, to adopt actions of preventive, corrective, continual improvement etc, that make process is still stabilization control under the influence of some interference elements, and improve stability and effective of manufacture process and ability. 2.范围Scope： 适用于从原材料直至交付过程中的所有影响产品质量的活动，包括产品的各道加工工序、顾客对产品的满意程度等过程的审核。 This procedure applies to the actions of all effecting product quality from raw material to delivery process, including the audit of each manufacturing process of product, the product satisfaction level of customer, etc process. 3.术语Terms： 无None 4 职责 Responsibility： 4.1 CTO负责过程审核（含专项审核）的整体策划和管理，负责公司过程审核管理程序的编制、修订及管理；负责聘任过程审核员，制定过程审核年度计划，编制审核报告。 CTO is responsible for the total plan and manage of process audit (including special project audit ), responsible for compiling, revising and managing of the company process audit management, responsible for appointing process audit, formulating process audit annual plan，prepare audit report. 4.2 受审部门负责接待审核组，接受、配合审核并根据审核中提出的问题，采取相应的纠正措施。 Department to be audited is responsible for receiving audit group, accepting and cooperating audit and taking appropriate corrective actions according to the question of audit. 4.3 审核组负责具体审核的策划、实施和不符合项（或问题）整改验证工作。 Audit group is responsible for the specific audit work of planning, implementing and verifying of non-conformity ( or problem ) corrective. 5.活动程序 Activity procedure： 5.1 审核依据 Audit bases 公司的过程审核依据包括不限于：TS16949管理体系标准、质量手册、程序文件、产品标准、工艺技术文件（过程流程图/生产控制计划/作业指导书/检验指导书）、顾客对产品质量的反馈、操作人员的能力要求、设备的预见性/预防性维护要求、工作环境的要求、顾客的其他要求等。 Basis of company process audit, including but not limited :ISO/TS 16949 Qua