1、供应商质量体系及监督审查之管制程序Revision HistoryREVDCN #INITIATEDBYEFFECTIVEDATE (MM/DD/YY)DESCRIPTIONA00 D142525William Magramo6/16/14Initial ReleaseApproved DCN on File in Document ControlAPPROVED BYMotoaki WakuiAUTHORIZED BYSK LamCONFIDENTIALPROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDThis documen
2、t, and the information it contains, are the property of Zhongshan Sunming Optical Technologies Limited and are protected by law. Both must be held in strict confidence at all times. No license expressed or implied, under any patent, copyright or other intellectual property right is granted or implie
3、d by the provision or possession of this document. No part of this document may be reproduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form or by any means, whatsoever, without the prior written consent of Zhongshan Sunming Op
4、tical Technologies Limited.2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDALL RIGHTS RESERVED1. PURPOSE 目的1.1 This specification describes the general requirement and procedure for quality systems and surveillance audit of SUNMING Supplier. 此规格书描述了SUNMING对供应商质量体系的一般要求及监督审查程序。1.2 SUNMING use a qu
5、ality system assessment tool “Attachment 1” to ensure that suppliers supplying products or material piece parts meet all the requirements for basic quality systems as defined by the company. The requirements specified are aimed primarily at achieving customer satisfaction by preventing non conformit
6、y at all stages from design through to servicing. SUNMING使用质量体系评估工具（附件1）确保供应商提供的产品或材料部件符合公司基本质 量体系的要求。这些要求所要达成的目标是从研发到售后服务预防不合格品的发生并将客户的满 意度放在第一位。2. SCOPE 范围2.1. Any supplier of all direct materials as described below where the requirement for the audit toISO 9001 are identified.ISO 9001要求审核直接材料供应商包
7、括以下所描述的方面 Electro Mechanical 电子机械 Electrical Hardware电气硬件 3. DEFINITIONS & ABBREVIATIONS 定义与缩写3.1 Direct materials Those materials being used during manufacturing of the Product, which are components in the Product. 直接材料 - 指那些产品生产过程中用到的材料，是产品的部件。3.2 Indirect materials - Those non-product related goo
8、d such as equipments, office supplies and furniture, etc. 间接材料 - 那些与产品无关的物件，如设备，办公用品及办公设备。3.3 CLCA Close Loop Corrective Action 闭环更正措施3.4 FG - Finish Goods3.5 QSA- Quality System Audit 质量体系审核3.6 SQE- Supplier Quality Engineer 供应商质量工程师3.7 SUNMING Zhongshan Sunming Optical Technologies Limited (China
9、registered company)/ 中山三鸣光学科技有限公司 （中国注册公司）/ Sunming Technologies (HK) Limited (Hong Kong registered company) 三鸣科技香港有限公司 （香港注册公司）4. ASSOCIATED DOCUMENTS 相关文件1.0 PR200015. GENERAL REQUIREMENTS 一般要求5.1 QA (SQE) and Purchasing (Buyer) should conduct Supplier Quality Audit. If necessary, additional perso
10、nnel shall be included in the audit team to provide technical expertise (e.g. from R&D and Manufacturing). QA部门（供应商质量工程师）及采购部门（采购员）应实施供应商质量审核。 必要的话，审核小组要包含其他人提供专业技术（例如：研发部或生产部人员的加入）。 5.2 Supplier Classification 供应商等级 Level 1 - Suppliers who are ISO 9001 certified. 1级 - 获ISO 9001认证的供应商 Level 2 - Supp
11、liers who are not ISO 9001 certified. 2级 - 未获得ISO 9001认证的供应商 5.2.1 Level 1 Suppliers 1级供应商 5.2.1.1 Level “1” suppliers are audited for minimum of once every year and skip for two years if there is no quality issue or complain. 1级供应商每年至少审核一次，若没有质量问题或投诉可以两年审核一次。 5.2.1.2 Supplier Quality Engineer (SQE)
12、 shall require suppliers to send the latest copy of ISO certificate for file and reference. 供应商质量工程师应要求供应商发送最新的ISO证书副本以归档并参考。 5.2.2 Level “2”suppliers are audited for minimum of once every six months. 2级供应商至少6个月需审核一次。 5.3 Audit Preparation and Questionnaire 审核准备及问卷5.3.1 Prior to the audit, a copy of
13、 the quality audit questionnaire, “Attachment 1,” shall be send to the proposed auditee for completion in two weeks time. 审核前，将质量审核问卷（附件1）发送给被审核单位，被审核单位需在两周内完成问卷。5.3.2 Prior a week to the audit, the auditee shall return the completed questionnaire together with any additional information required i.
14、e. Organizational chart, Quality certification, Company product Brochure, Quality System Certification, Audit records for the past six months both internal and external audit, & General Information Sheet. 审核前一周，被审核单位需将完成的问卷同要求的其他附加信息一起送还，附加信息包含： 组织结构图，质量证书，公司产品手册，质量体系证书，过去6个月里内部及外部的审核 记录，一般信息表。 5.3.
15、3 The auditee shall be notified on the proposed audit and date. 审核方需通知被审核方审核计划及日期。 5.3.4 The exact date shall be agreed between the auditee and auditor. 审核日期需经过双方确认一致。5.4 Audit Checklist Requirement 审核清单要求 The following documents and procedures need to be provided by the auditee at the beginning of
16、the audit to expedite the audit process. 被审核方在审核初期需提供以下文件及制程使审核顺利进行： 5.4.1 Workmanship standards 工艺标准 5.4.1.1 Drawings if applicable 图纸，如果适用的话 5.4.1.2 Test Specifications 测试规格书 5.4.1.3 Product specifications 产品规格书 5.4.1.4 Manufacturing/Quality Plans 制造 / 品质计划 5.4.2 Quality Manual 质量手册 5.4.3 Quality
17、Manual level 2 procedures 质量手册2及程序文件 5.4.4 Quality Performance Measures 质量绩效评估 5.4.5 Process Flow Diagrams 制程流程图 5.4.6 Organization Chart(s) 组织机构图 5.4.7 Job Descriptions 工作描述 5.4.8 On-Going Reliability Testing Plans 持续可靠性测试计划 5.4.9 ISO Certification (if applicable) ISO 证书（可用的话） 5.4.10 Document Contr
18、ol Index 文件控制指引 5.4.11 Calibrated Equipment List 已校正设备清单 5.4.12 Corrective Action Log 更正措施记录 5.4.13 Audit records for the past six months, internal and external 过去6个月内外审核记录 5.5 SUNMING shall require the supplier to provide its internal audit and third party audit results when not audited on site acc
19、ording to the supplier audit plan provision.SUNMING需要求供应商提供其内审结果及未根据供应商现场审核计划规定的第三方审核结果。 5.6 Supplier shall provide copy of internal quality and ISO surveillance audit findings and corrective action on annual basis. 供应商应每年提供内部质量及ISO监督审核结果及更正措施。 5.7 The SUNMING quality audit team shall physically ass
20、esses the vendor capabilities using supplier rating sheet (Attachment 1) as checklist and make recommendation that might be helpful in improving the suppliers / vendors quality system. SUNMING质量审核小组应根据附件1供应商评级表作为检查表亲自评估供应商的能力并提出可 能有利于提高供应商质量体系的建议。5.7.1 Management Responsibility 管理职责5.7.2 Quality Sys
21、tem 质量体系5.7.3 Document and Data Control 文件数据控制5.7.4 Purchasing/Supplier Selection 采购/供应商选择5.7.5 Identification and Traceability 标示与可追溯性5.7.6 Process Control 制程控制5.7.7 Inspection and Testing 检视与测试5.7.8 Control of Measuring, Inspection and Test Equipment 测量，检视及测试设备控制5.7.9 Inspection and Test Status 检视
22、与测试状态5.7.10 Control of Nonconforming Product 不符合产品控制5.7.11 Corrective and Preventive Action 更正及预防措施5.7.12 Handling, Storage, Packing, Preservation, Delivery 搬运，存储，包装，保护及运输5.7.13 Quality Records 品质记录5.7.14 Internal Quality Audits 内部品质审核5.7.15 Training 培训5.7.16 Statistical Techniques 统计技术5.7.17 Contin
23、uous Improvement 持续改进5.8 Each category is assessing against checklist to evaluate vendor system based on the auditors professional judgment. 应检查每个类别对比检查表并根据审核人的专业判断来评估供应商体系。5.9 The audit measurements consolidate number of discrepancy (critical, major, and minor) for all the categories to come up wit
24、h an overall rating. 整合审核测量值及所有类别的不符合值（重大，主要，次要）形成一个综合评级。5.10 The rating summary is classified for the overall rating into different comments as shown in item 8. This will determine the vendor quality system or as the basis of recommendation, if applicable. 评级总结分类将综合评级分成项目8所示的不同的评论。这将决定供应商质量体系，适用的话，
25、 作为建议的基础。5.11 At the end of the audit, the team should hold wrap up meeting with the vendors representative to discuss the audit highlight, concern, recommendation and corrective action request for for improvement. 审核结束，审核小组与供应商代表召开总结会议，讨论审核重点，关注，建议及改善的更正措施 建议。5.12 The Lead Auditor should submit the
26、 report to the Head of Quality with an overview narrative of the strengths, any critical, major and minor discrepancies noted in the audit, along with the observation recommendation. Appropriate corrective action report using CLCA together with the Audit rating score card. 审核组长应向品质部领导提供一份报告，该报告包括：优势
27、的综合叙述，审核中任何重大、主 要、次要的不符及观察建议，适当的更正措施报告（闭环纠正措施），审核评级计分卡。 5.12 Audit Discrepancy Category 审核不符合类别 5.12.1 Critical Discrepancies 重大不符A discrepancy which is considered to jeopardize safety, functionality and reliability and may require shutdown to take corrective action. 被认为危及安全，功能性，可靠性及可能需求无法用更正措施弥补的不符
28、。 Example 例如: Using a wrong drawing (wrong drawing number / version) 使用了错误的图纸（错误的图纸编号/版本） Reliability Test failure. 可靠性测试失败Course of action 行动步骤: Recall defective product if necessary in the event of safety issue. 如果存在安全问题，必要的话召回不合格产品。 Quarantine everything in the FG ware house (supplier & customer)
29、 for rework and recertification for compliance before releasing goods to customer. 隔离供应商及客户的成品仓进行返工，在产品发给客户前应满足符合性再认证。 Stop the production line/station and take corrective action. 停止生产线并采取更正措施。 Quarantine specific components having non-conformity in the supplier in-coming material store. 隔离供应商来料仓的不符
30、合的特定部件。 Quarantine component at supplier FG stores. 隔离在供应商成品仓的部件。 Review and confirm suppliers course of action is adequate to prevent recurrence. 审查和确认供应商的行动步骤足以预防复发。 Upon validation of compliance and with authorization by SUNMING QA staff, supplier can resume production and delivery of products. 确
31、认符合后，由SUNMING QA人员授权，供应商可恢复生产并运送货物。 5.12.2 Major Discrepancies 主要不符 A significant discrepancy which is considered to indicate non-compliance to the quality system (QMS) or an unacceptable threat to quality and reliability of the product. 重要不符指与质量管理体系不符或对产品的质量和可靠性造成无法接受的威胁的产 品。 Examples 例如: Handling the ESD sensitive component without ESD protection. 有没防静电保护的情况下处理静电敏感部件。 Use of expired material without having approval or recertification 在没有得到批准或再认证的情况下使用过期材料。
