Internal Audit procedure 内部审核程序（中英版）

1、LOGOQUALITY SYSTEM PROCEDURE 质 量 体 系 程 序Number 文件编号:PD-M3-01Department 部门:QA 质量部 Subject 文件名称:Internal Audit procedure 内部审核程序Revision版本: 2.0Effective Date生效日期:2014-03-13Page 4 of 5批准：Jason Zhang审核：Jim Geng作成：Sandy HeChange History 变更记录Revision 版本Effective Date生效日期Originator编写人Reasons for Change修改原因1

2、.02012-01-01Sandy HeOrigin Revision2.02014-03-13Jim GengUpdate 4.3.1&4.4.4，Add internal auditor evaluation and product audit explanation3.02014-05-10JasonZhangUpdate 4.3.1,Delete internal auditor evaluation 4.02015-02-05JasonZhang增加过程/产品审核的频次定义1.0 Purpose目的This procedure describes how internal audit

3、s of the Management System (including Quality Management System and Environmental Management System) are conducted, how Non-conformances are recorded and how corrective actions are agreed, implemented and verified.本程序描述了如何对公司管理体系（包括质量管理体系和环境管理体系）进行内部审核，如何记录不符合事项以及如何制定、实施和验证纠正措施2.0 Scope范围This proced

4、ure applies to Management System (including Quality Management System and Environmental Management System) internal audit, process audit and product audit in MATK.本程序适用于本公司（MATK）与管理体系（包括质量管理体系和环境管理体系）有关的审核活动，包括质量管理体系审核、环境管理体系审核、过程审核、产品审核。3.0 Definitions定义3.1 IMSA :Internal Management System Audit/内部

5、管理体系审核;3.2 Internal Auditor: Based on training, a person who is capable and qualified to audit the performance of Management System.内审员：经过相应培训，具有能力和资格对公司管理体系状况进行审核的员工3.3 Audit Team Leader: A person who is recommended to take charge in the internal audit.内审组长：指定的负责全程内审的人员3.4 Audit Criteria: A series

6、of policies, procedures and requirements, which are used as basis for audit.审核准则：所依据的一系列的方针、程序或要求3.5 Audit Evidence: Any fact, record or other information that can be got during audit.审核证据：与审核有并能够证实的记录、事实陈述或其他信息3.6Audit Finding: The result after evaluating the audit evidence based on the audit crite

7、ria. 审核发现：所收集到的审核证据对照审核准则进行评价的结果3.7 System Audits: Systematic assessment for quality and environmental management to verify the effectiveness. 体系审核：对质量和环境管理体系进行审核，以确认体系运行的有效性。3.8 Process Audits: audit each manufacturing process to determine its effectiveness. 过程审核：对每个制造过程进行审核，以确定其有效性.3.9 Product Aud

8、its: Assessment of products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency.产品审核：在生产和交付的适当阶段对产品进行审核，以验证符合所有要求，如产品尺寸、功能、包装和标签等.3.10 Critical Nonconformity: Th

9、e nonconformity will affect the operation of whole management system; the same nonconformity happens in several departments and will affect the operation of whole system; the operation is severe nonconforming with manuals requirements. 严重不符合事项：影响整个管理体系运行的重大不符合；或同一类不符合事项发生在数个部门足以影响整个体系运行；或执行的事项与手册的规定

10、严重不符合时。3.11 Common Nonconformity: Except the critical nonconformities, other operation or mistakes that dont comply with the procedure or not reach the requirements.一般不符合事项：除上述主要不符合事项外，其余没有遵守公司工作程序的某一项过失或没有达到规定要求时，称之为一般不符合事项。3.12 Observed Item: The operation has not disobeyed the system requirements

11、 or has no evidence to show that audit findings are conformity, but the operation result maybe will affect the system.观察事项：虽未违反体系要求或没有客观证据可证明所发现的事实足以构成不合格，但结果可能会影响体系的事项。4 Procedure and Flow chart 程序及流程图1.02.03.04.04.1 Responsibility and authority职责与权限4.1.1 The QEMS Representative is responsible for

12、approval of the audit plan and ensuring that the internal audits are conducted in accordance with audit schedule.管理者代表批准审核计划，确保按照内审计划实施内部审核；4.1.2 Quality Dept. is responsible for making audit plan, coordinating the implementation of internal audit, summarizing the audit result and following up the c

13、orrective action and effectiveness.质量部负责制订审核计划，协调内审实施，汇总审核结果，跟踪审核改善和效果。4.1.3 An internal audit team leader is responsible for whole audit activity.内审组长负责整个的内审过程。4.1.4 The auditors are responsible for reporting the details of any findings, issue CAR, and subsequently verifying the corrective actions

14、taken.内部审核员负责实施审核，汇报审核发现，提出纠正和预防措施要求，并跟踪验证纠正预防措施的执行。4.1.5 Other dept assist audit and take corrective and preventive action for Non-conformance.其他部门：配合审核，并对不符合采取纠正预防措施。4.2 Audit Plan 审核计划4.2.1 Quality department make internal audit plan, including QMS & EMS audit, process audit and product audit, th

15、en get approval from Management Representative. 质量部制定年度内部审核计划，包括质量体系审核、环境体系审核、过程审核、产品审核，并由管理者代表批准。4.2.2 The QMS and EMS audit, process audit and product audit will be conduct once per year. Process audit and product audit should be performed according to customers frequency while they had the specia

16、l audit frequency requirements. Management Representative can increase the frequency considering the previous performance, the importance of process and product, internal and external nonconformance and critical customer complaint.审核频次：每年1次质量体系审核、环境体系审核、过程审核、产品审核，当客户有对过程审核及产品审核有特定要求时，频度按照客户要求实施，具体参见

17、审核计划。管理者代表可根据以往的质量/环境绩效、过程/产品重要性、内外部不符合、重大客户投诉事件等，增加各类审核的频次。管理者代表视需要可不定期举行内部审核。(开发阶段:在客户签署PPAP 前完成过程/产品审核；量产阶段:PPAP 签署后每年进行一次过程、产品审核)4.3 Auditor Qualifications 审核员资格4.3.1 The QMS and EMS internal auditors shall be trained by the qualified training institute and get the certification. QMS /EMS 内审员：1.

18、 有资质的培训机构培训的ISO/TS16949 和ISO14001 内审员，并取得合格证书。4.3.2 Process auditor: engineer familiar with the production process and with one year experience. 过程审核员： 熟悉产品生产过程，公司工作一年以上的工程师。4.3.3 Product auditor: quality engineer familiar with product requirements and with one year experience.产品审核员：具备产品检验能力，熟悉产品要求，

19、公司工作一年以上的质量工程师。4.4 Preparation of audit 审核准备4.4.1 Auditor make internal system audit checklist Internal Audit checklist.内审员制定内部体系审核的审核表内部审核检查表。4.4.2 The system internal audit criterion is ISO/TS 16949 and ISO 14001Standards, Quality and Environment Manual, Procedures and Working Instruction, Contrac

20、t requirements and National legal requirements, etc.体系审核以ISO/TS 16949和ISO 14001标准、公司的质量和环境管理手册、程序文件、相关的作业指导书、规范及国家的法律法规等为依据。4.4.3 Process audit assess the quality ability for manufacturing process. Quality dept prepare engineering specification, process requirement, product standard to make Process

21、Audit checklist.过程审核是对产品制造过程的质量能力进行评定，质量部准备各类准则技术要求，工序准则，文件，产品标准，确定过程审核表。4.4.4 Product audit assess product quality level, including product dimension, appearance, function, packing, label and etc. Quality dept prepare engineering specification, product standard, defect grade table, test plan and et

22、c. to make Product Audit checklist.产品审核：对已检验合格的产品进行再检查，包括产品尺寸，外观，性能，包装，标签等，以评价其质量水平以及是否需采取改进措施。质量部准备各类技术资料产品标准，缺陷分级表，试验计划等，确定产品审核表。4.5 Audit implementation 审核的实施4.5.1 Internal system audit 内部体系审核 A) Quality department lead to audit team and choose appropriate auditor, determine the team leader, and

23、then send Internal Audit Schedule.质量部主导成立审核小组，选择合适的体系审核员，确认审核组长，发出内部审核实施计划。B) The Audit team leader call open meeting in accordance with audit schedule and confirm the audit schedule with auditors, related department managers.审核组长按计划召开体系审核的首次会议，审核员、受审核部门的负责人和相关管理人员参加，确认审核行程。C) Auditor looks for the

24、evidence of conformance according to audit plan and audit checklist and record the audit findings. 内审员按审核计划和审核表进行审核，寻找符合性证据，并在审核表上记录审核发现。D) The Audit team leader call close meeting and report the audit result, confirm the nonconforming items with related department.现场审核结束后，审核组长召开末次会议，报告审核结果，确认不符合项。E

25、) The Audit team leader summarizes the audit result and submits the, FN-QA-046 Internal system Audit Report to all departments and Management representative, and as one input of management review.审核组长汇总审核结果，提交FN-QA-046 内部体系审核报告给各部门和管理者代表，并作为管理评审的输入之一。4.5.2 Process audit and Product audit 过程审核和产品审核 A

26、) Auditor looks for the evidence of conformance according to audit plan and audit checklist and record the audit findings. MMK follows VDA 6.3 to perform process audit for each station if theres no customer special request.审核员按审核计划和审核表进行审核，寻找符合性证据，并在审核表上记录审核。如果客户没有特殊要求时；本公司参考VDA6.3的要求对每个过程进行过程审核。B)

27、The Auditor summarizes the audit result and submits the internal audit summary report to all departments and Management representative, and as one input of management review.审核员汇总审核结果，提交审核结果给各部门和管理者代表，并作为管理评审的输入之一。4.6 Corrective and improvement action 纠正改进措施4.6.1 The auditor issue Corrective and Preventive Action Report (CAR/PAR) for nonconformance findings to the responsible dept.审核中发现不符合，审核员开出FN-QA-056 不符合报告，交责任部门限期改善。4.6.2 The audited department shall provide corrective and preventive action plan in one week to impro