供应商PCN管控-Requirements-for-Supplier-Change-Control

-1. Purpose and Scope 目的和范围This document describes the control requirement for supplier process change in 4M1E (Man, Machine, Material, Method, and Environment), to make sure these change will not impact the company assembly and product quality /safety. 本程序规定了XXX有限公司对供应商过程变更的管控要求，包括人、机、料、法、环的变更，确保这些变更受控，不对公司的组装生产、产品质量和安全产生不良影响。Its valid for all suppliers in AVL. 适用于所有列入合格供方名录的供应商。2. Nomenclature 术语 AVL: Approved Vender List 合格供方名录 PCR: Process Change Review 过程变更评审 PCN: Process Change Notification 过程变更通知 MSA: Measurement System Analysis 测量系统分析3. Responsibility 职责The purchasing department shall communicate this requirements to all suppliers, and monitor if they follow the procedure. 采购部门应将管控要求传递给供应商，并监督供应商是否遵照执行。All suppliers must strictly follow our supplier PCN procedure and inform us in advance for raw material process change, and only can implement change after our finally approve it. Supplier self-qualification report should include information of ISO certification, material analysis report, inspection report, FMEA, etc., detail can provide based on change situation. 供应商应严格遵照执行我司对供应商过程变更的管控要求，如有PCN变更应提前通知我司，经我司同意后方可实施变更。供应商应提供内部确认报告，包括各类ISO认证证书、材料分析报告、检验报告、FMEA报告等。4. Implementation 执行要求4.1 All supplier process change are defined as Major, Medium, Minor, and informed us as the response requirement, see Table 1 as below. 供应商过程变更可分为重大、中等、次要变更。供应商应按下表1的应对要求执行。Table1: Change Classification and Supplier Response Requirement表1：变更级别及供应商应对要求Change classification 变更级别Response to XXX Shanghai 供应商应对要求Major重大Major change require XXX part / material re-qualification重大变更需要XXX对零件/原材料重新确认、批准1. Need XXX approval before implementation 需要XXX批准后方能实施2. Supplier sends XXX PCN via email before 3 months 供应商提前3个月邮件发送PCN，通知XXX过程变更3. Supplier sends XXX material/part sample before 3 months 供应商提前3个月提交零件样品4. Supplier sends XXX material analysis report, part quality report / test report, etc. before 3 months 供应商提前3个月提交XXX材料分析报告、零件检验/试验报告等Medium中等Change require supplier re-qualification. 供应商需对该类变更进行自我确认。Or change has effect on XXX operation system but no effect on quality/safety parameter. 或该类变更不影响品质、安全，但影响XXX日常操作1. Need XXX approval before implementation. 实施前应通知XXX2. Supplier sends XXX PCN vial email 供应商通过邮件发送XXXPCN3. Supplier sends XXX quality/test report 供应商提交检验/试验报告4. XXX review the data and confirm if approval. XXX评估数据，确认是否批准Minor次要Change has no effect on quality/safety, operation system or capacity. 变更对品质、安全、日常操作、产能没有影响Need get XXX s recognition for PCN class definition before implementation.实施前请与XXX确认PCN级别4.2 Detail classification to supplier process change and supplier evaluation data required as Table2. 具体变更项目及其级别、以及供应商需提供的数据见表2。Table 2 Change Item and Data Required 表2： 变更项目和要求数据Change Item 变更项目Class.级别Data required 要求数据Man 人Main operators change 主要操作人员变更Minor 次要Training/qualification record if required 需要时请提供培训/资格认定记录Main QC employees change 主要检验人员变更Medium中等PCN 过程变更通知MSA if required 需要时提供测量系统分析报告Machine 机Key manufacturing machines / equipments change关键生产加工机器/设备变更Major 重大PCN 过程变更通知Machine capacity comparing / analysis设备能力比较/分析quality data before/ after change 检验数据比较分析others if required 其他必需数据Key measuring tools change 关键测量工具变更Major 重大PCN 过程变更通知MSA or measuring data comparing / analysis 测量系统分析或测量数据比较/分析报告Non-key processing / measuring devices change 非关键加工/测量设备变更Minor 次要Keep tracing record internally and provide if required 保持记录以便追溯Material 料Raw material change or substitute used 原材料更换或替代Major 重大PCN 过程变更通知Part sample and FQC report 样品零件及检验报告Raw material quality certification 原材料材质证明Certificate of Origin if imported 进口材料原产地证明Material analysis report 材料分析报告Other certificates if required 其他Raw material source/ supplier change 原材料来源/供应商改变Major 重大Key characteristics change of raw material 原材料关键特性更改Major 重大Raw material batch change 原材料批号更改Medium 中等PCN过程变更通知FQC report 检验报告Raw material quality certification 原材料材质证明Certificate of Origin if imported 进口材料原产地证明Method 法Key process condition change, e.g. processing parameter, processing method, process step 关键加工条件变更如工艺参数、加工方法、加工工序等Major 重大PCN 过程变更通知Parts sample and FQC report 零件样品及检验报告Quality/reliability data comparing and analysis 质量/可靠性数据比较和分析Others if required 其他Non-key process condition change 非关键工艺条件更改Minor 次要Keep tracing record internally and provide if required 保持内部追溯记录Measuring method / criteria change of final control 出货检验方法/标准更改Medium 中等PCN 过程变更通知FQC report 终检报告MSA or quality data comparing/ analysis if required 需要时提供测量系统分析或检验数据对比分析Label printing / applying method change 标签印刷/张贴方式更改Medium 中等PCN 过程变更通知Packing method change 包装方式更改Medium 中等PCN 过程变更通知Reliability test data 可靠性数据Environment环境Manufacturing site change 生产场地变更Major 重大PCN 过程变更通知Parts sample and FQC report 样品零件及检验报告Manufacturing / Process capacity 加工能力/过程能力分析Raw material quality certification 原材料材质证明Certificate of Origin if imported 进口材料原产地证明Quality data before/after change 质量数据对比 Others if required 其他Others 其他Supplier company name change 供应商公司名称更改Minor 次要PCN 过程变更通知Others not listed 其他TBDGet XXX s recognition 请与XXX确认变更等级及管控要求4.3 The purchasing order or payment will be stopped or delayed if XXX Shanghai find some supplier doesnt follow our requirements. If any customer complaint or