Number: Effective Date: Revision #: Revision Date: Page#: QD-04 06-Nov-07 A02 20-Sep-13 1 of 4 SOP/WIs Quality Supplier Audit 供应商审核作业指导书 logo 1. PURPOSE(目的) To assess the quality performance of existing or potential suppliers. 评估现有供应商或潜在供应商的质量表现。 APPLICATION(适用范围) The procedure applies specifically to key suppliers (supplier of strategic material, …… ) that affects the quality of our products. 该程序特别运用于重要供应商(战略性材料、……材料供应商),他们提供的物料会影响到本公司产品的质量。 2. 3. DEFINITION(定义) 3.1. Supplier: Organization or person that provides a product. 供应商:提供产品的组织或个人。 3.2. Audit: Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. 审核:审核是一种评价活动;评价审核证据满足审核准则的程度。这种评价应该是客观地、系统地、独立地进行并形成文件。 3.3 SCAR: supplier corrective action request, which could be from audit findings, supply discrepancies. SCAR: 供应商纠正措施要求单,通常是根据审核发现或供货缺陷提出来的。 ASSOCIATED MATERIAL(相关文件) 4. QP-07-Supplier & Material Approval QP-07-供应商和原材料批准程序 5. RESPONSIBILITY(职责) 5.1. Purchasing & QSHE are responsible for supplier audit planning, and need the suggestion from related managers (e.g. Technical Manager for strategic material, Maintenance Manager for mold, Warehousing Supervisor for key packaging material, or the head of using dept). 采购和QSHE负责制定供应商审核计划,需参考相关部门经理的建议(如:技术经理——战略性材料,维修经理——模具,仓储主管——关键包装材料,或使用部门负责人)。 5.2. Purchasing Representative is responsible for arrange the On-Site-Audit (OSA) with the suppliers and keeps the smooth communication between both sides in all business processes including supplier corrections following-up. 采购代表要负责同供应商安排现场审核(OSA),双方要在业务过程上保持顺畅的交流,包括供应商纠正措施的跟踪。 5.3. QSHE Representative takes the leading of the whole OSA, from planning, to performing and reporting. Purchasing dept updates the Approved Supplier List according to the results from OSA. QSHE要主导整个OSA过程,从审核计划,到实施到结果报告。采购部门根据OSA的结果来更新批准供应商清单。 Written by Checked by Approved by Number: Effective Date: Revision #: Revision Date: Page#: QD-04 06-Nov-07 A02 20-Sep-13 2 of 4 SOP/WIs Quality Supplier Audit 供应商审核作业指导书 logo 6. CONTENTS(内容) 6.1. Supplier Audit Procedure供应商审核过程 Supplier Audit Procedure供应商审核程序Audit Decision and Plan审核决定和计划Purchase & QSHE 采购和QSHECommunication with the supplier与供应商交流OSA Criteria & DocumentsOSA标准和文件Conducting OSA开展OSAFollow up跟踪Communicating OSA Purchasing Representative采购代表Auditors and QSHE manager审核员和QSHE经理Auditor Team审核组Finding to the supplie与供应商进行OSA发现交流Auditor Team审核组Supplier Audit Report供应商审核报告Supplier Correction Request if neccesary看是否有必要要求供应商进行纠正措施Update Approved Supplier List更新合格供应商清单Auditor Team Leader审核组长Auditor Team审核组Purchase Department采购部 6.1.1 QSHE & Purchasing departments designate a supplier for an audit based on how critical the material is to our processes and products. 质量部和采购部根据材料对我公司过程和产品的重要性来选择供应商进行审核。 6.1.2 This conclusion is based on such items as usage, number of suppliers and evaluations of production permits and Supplier Corrective Action Requests (SCARs). 结论综合多项因素得出,例如:物料的使用,供应商数量和生产中的测评和供应商纠正预防措施(SCARs)。 Written by Checked by Approved by Number: Effective Date: Revision #: Revision Date: Page#: QD-04 06-Nov-07 A02 20-Sep-13 3 of 4 SOP/WIs Quality Supplier Audit 供应商审核作业指导书 logo 6.1.3 On site audits (OSAs) are not required but may be conducted on any supplier or potential supplier. 现场审核(OSAs)不是必须的,但是可以在任何供应商或潜在供应商内开展。 6.1.4 Normally the audit team is consisted of the representatives of QSHE, Purchasing, related department (Technical for raw materials, Warehousing for key packaging material, and Maintenance for Mold, or the using department), and lead by QSHE. The lead auditor prepares a plan using the Supplier Audit form. The plan section of this form is filled out as follows: 通常由QSHE、采购和相关部门的代表组成审核组,用供应商审核表来准备审核计划。表格的计划部分按照以下信息填写: ? Number of the supplier audit (next sequential number from Supplier Audit log in Quality Department office). 供应商审核编码(下一个序列号在质量部的供应商审核汇总表中获得)。 ? Name of the plant using the material (……). 使用材料的工厂名称(……)。 ? Planned audit date. 计划审核日期。 ? Name and address of the supplier. 供应商名称和地址。 ? Audit subject. 审核主题。 ? Additional details may be added to the detailed audit plan, if required. 如果有要求,可以在详细审核计划上加上详细信息。 ? Signatures of persons preparing the plan and date. 准备人签名和日期。 6.2. Purchasing Dept and related managers review the plan, and make any corrections if necessary. QSHE Manager need approve it. 采购部和相关经理须审核计划,必要时进行修改。QSHE经理批准后实施。 6.3. The audit is coordinated with Purchasing Representative, who following any corrections by signing and dating the form. 审核由采购代表协调,并遵循6.2过程中所做的修改。 6.4 . The audit is conducted according to the detailed plan and SCARs or non-compliances are issued, if necessary. 审核要根据具体计划和此前发放的SCARs和不符合项(如果有)来实施。 6.5 . The lead auditor prepares a report. He may use the Supplier Audit form or create his own document with the following information: 审核组长准备报告。他可以利用供应商审核表格来创建,或自建报告,要包括以下信息: ? Name of people involved in audit. 参与审核的人名。 ? Actual audit date. 实际审核日期。 ? Audit findings (include SCARs and non-compliances issued). 审核发现(包括发放的SCARs和不符合项)。 Written by Checked by Approved by Number: Effective Date: Revision #: Revision Date: Page#: QD-04 06-Nov-07 A02 20-Sep-13 4 of 4 SOP/WIs Quality Supplier Audit 供应商审核作业指导书 logo ? Conclusions and suggestions 审核结论和建议 ? Signatures of auditors. 审核员签名。 6.6. QSHE manager review and approve the audit report, and distribute it to related departments. QSHE经理负责审批审核报告,并发至有关部门。 6.7. Purchasing is responsible for communicating the audit results with the supplier, and forwarding the SCAR(s) if any. The original report is filed in the QSHE office. 采购要负责同供应商沟通审核结果,并转发SCAR。审核报告原件要保存在质量部。 6.8 Purchasing and the auditors follow-up on any SCARs or non-compliances issued to verify compliance with requested due dates. 采购和审核员要跟踪所有发放的SCARs或不合格项,验证是否符合要求完成的日期。 6.9 The conclusion of the audit should be one of inputs of supplier approval. 审核结论是一项供应商批准的重要输入。 7. APPENDIX(附件) ? QD-04-Appendix A Supplier Audit Form QD-04-附件A 供应商审核表 ? QD-04-Appendix B-Supplier Audit log QD-04-附件 B 供应商审核一览表 ? QD-04-Appendix C Supplier Corrective Action Request (SCAR) QD-04-附件 C 供应商纠正措施要求 (SCAR) Written by Checked by Approved by
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