变化点管理办法

变化点管理办法 chronic gastritis of causes, and diagnosis method, and identification diagnosis and the treatment; Digest sex ulcer of onset mechanism, and clinical performance, and identification diagnosis, and complications and the processing; Helicobacter pylori spiral Bacillus and gastritis and the ulcer disease of relationship; business acid agent as H2 receptor block agent and Proton pump inhibitors of pharmacological role and the clinical application; stomach mucosa protection agent of pharmacological role and clinical role; Helicobacter pylori spiral Bacillus of treatment; Crohn's disease and ulcer sex colon inflammatory of identification points and the treatment; cirrhosis of onset mechanism, compensatory period and lost compensatory period of performance; liver sex brain disease, and door pulse high pressure of produced mechanism; abdominal product liquid formed of reasons and the experiment check of features, and identification method and processing; light acute pancreatic inflammatory and heavy syndrome acute pancreatic inflammatory of difference and the General processing; Shang Digest road bleeding of emergency processing; three cavity two SAC tube oppression bleeding of indications, and taboo syndrome; liver puncture biopsy of indications, and taboo FH/ZD015 变化点管理办法 一、目的 1、规范公司各作业潜在变化因素，使各潜在变化因素处于受控状态。 二、范围 1、各作业流程(环节)所涉及的人、机、料、法、环; 2、涉及部门:原料部、橡胶部、塑胶部、品质部等; 三、定义: 1、首件——又名“初物”，见“初物管理办法”。 2、首件确认时机; 2.1材料或嵌件批次更换，含抽料、染色料、在生料之间的相互换料; 2.2工装、设备调整、维修或更换后; 2.3停机1小时以上，恢复生产前; 2.4转班(或节假日后)从新开机生产产品前; 2.5 未停机器之正常交接班生产之产品。 3、首件确认内容; 3.1未停机器之正常交接班生产之产品的首件确认，一般确认外观、主要尺寸等常检 (能快检)项目。 3.2其余2.1~2.4之首件确认时，一般必须全项目检测。 四、流程和管理办法 1、岗位员工及由员工变化引起的变化点管理: 1.1 员工进入工作岗位前，必须接受部门的岗前培训，包括安全、工作要求;培训后接受部门的考核——理论和实际操作;根据考核情况，用人部门绘制“员工技能评价一览表”交人力部门掌握，同时提交部门生产 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 人员用于“计划排程”之定员依据;车间现场用白版绘制出并保持最新状态的“员工技能矩阵表”，并配上2寸彩照。 1.2 人员的安排，不可以超出“员工技能矩阵表”标明岗位技能之外; 1.3 作业过程凡人员有异动的，同时人员变动会对作业过程(或结果)有显著影响的，立即列入“变化点管理”——首件确认。 1.4 确认合格后，由作业部门在该批有“人员”变化因素之产品流转卡上盖“变化点-人”之蓝色印章，如图: 变化点 人 abooand t sing; three cavity two SAC tube oppression bleeding of indications, and taboo syndrome; liver puncture biopsy of indications,ndrome acute pancreatic inflammatory of difference and the General processing; Shang Digest road bleeding of emergency procesavy syns and the experiment check of features, and identification method and processing; light acute pancreatic inflammatory and hermance; liver sex brain disease, and door pulse high pressure of produced mechanism; abdominal product liquid formed of reasoperfo of identification points and the treatment; cirrhosis of onset mechanism, compensatory period and lost compensatory period ofl role and clinical role; Helicobacter pylori spiral Bacillus of treatment; Crohn's disease and ulcer sex colon inflammatory ogicaand Proton pump inhibitors of pharmacological role and the clinical application; stomach mucosa protection agent of pharmacol er pylori spiral Bacillus and gastritis and the ulcer disease of relationship; business acid agent as H2 receptor block agentmechanism, and clinical performance, and identification diagnosis, and complications and the processing; Helicobactchronic gastritis of causes, and diagnosis method, and identification diagnosis and the treatment; Digest sex ulcer of onset - 1 - 1.5具备相等技能或更高技能等级的人员替换，不列入“人”的“变化点管理”。 2、设备、模具、工装及由设备、模具、工装变化引起的变化点管理: 2.1 生产安排实行定机生产。 2.2 设备、模具、工装出现异常、故障，使用部门应立即向设备、模具部门提交维修单，设备、模具部门诊断故障并明确维修完成期限。 2.3设备、模具、工装修复以设备、模具部门试车成功为 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 。成功后使用部门现场主管应在维修申请单上签字确认，同时组织实施“变化点管理”——首件确认。 2.4 确认合格后，由作业部门在该批有“机”变化因素之产品流转卡上盖“变化点-机”之蓝色印章，如图: 变化点 机 2.5 是否执行定机定员，由现场主管自查自纠;品质部和稽核室依据“员工技能矩阵表”和当班之“维修申请单”稽查。 3、材料(备件)及由材料(备件)变化引起的变化点管理: 3.1 生产安排严格执行技术 资料 新概念英语资料下载李居明饿命改运学pdf成本会计期末资料社会工作导论资料工程结算所需资料清单 ——BOM和图纸要求，包括材料牌号、产地、供应商、回料比例。 3.2 凡出现材料牌号、产地、供应商、回料比例的变化(满足技术资料要求的前提下)，使用部门应立即组织实施“变化点管理”——首件确认。 3.3 确认合格后，由作业部门在该批有“料”变化因素之产品流转卡上盖“变化点-料”之蓝色印章，如图: 变化点 料 3.4 是否执行材料(备件)之变化点管理，由现场主管自查自纠;品质部和稽核室依据BOM和生产计划表稽查。 4、法(作业标准及工艺条件)及由法(作业标准及工艺条件)变化引起的变化点管理: 4.1 生产现场执行“作业准备验证”——作业标准和工艺条件必须受控，且现场“易得”，方便作业人员和管理、监督人员使用。 4.2 凡法(作业标准及工艺条件)变化(超出技术资料许可的公差范围)，生产部门应立即组织实施“变化点管理”——首件确认。 abooand t sing; three cavity two SAC tube oppression bleeding of indications, and taboo syndrome; liver puncture biopsy of indications,ndrome acute pancreatic inflammatory of difference and the General processing; Shang Digest road bleeding of emergency procesavy syns and the experiment check of features, and identification method and processing; light acute pancreatic inflammatory and hermance; liver sex brain disease, and door pulse high pressure of produced mechanism; abdominal product liquid formed of reasoperfo of identification points and the treatment; cirrhosis of onset mechanism, compensatory period and lost compensatory period ofl role and clinical role; Helicobacter pylori spiral Bacillus of treatment; Crohn's disease and ulcer sex colon inflammatory ogicaand Proton pump inhibitors of pharmacological role and the clinical application; stomach mucosa protection agent of pharmacol er pylori spiral Bacillus and gastritis and the ulcer disease of relationship; business acid agent as H2 receptor block agentmechanism, and clinical performance, and identification diagnosis, and complications and the processing; Helicobactchronic gastritis of causes, and diagnosis method, and identification diagnosis and the treatment; Digest sex ulcer of onset - 2 - FH/ZD015 4.3 确认合格后，由作业部门在该批有“法”变化因素之产品流转卡上盖“变化点-法”之蓝色印章，如图: 变化点 法 4.4 是否执行法(作业标准及工艺条件)之变化点管理，由现场主管自查自纠;品质部和稽核室依据作业标准及工艺条件稽查。 5、环(作业环境及显著影响过程结果的相关环境因素)及由环(作业环境及显著影响过程结果的相关环境因素)变化引起的变化点管理: 5.1 作业部门应提前识别生产所需的环境要求及显著影响过程结果的相关环境因素，并写入“作业标准”和“作业指导书”，并执行“作业准备验证”——作业所需的环境要求必须达到要求及显著影响过程结果的相关环境因素处于可接受状态。如作业台的灯光亮度、模具温度、作业台的高度应满足员工的舒适，检测仪器的防止震动、精测仪器的防潮等。 5.2 凡作业所需的环境要求及显著影响过程结果的相关环境因素变化(超出范围)，生产部门应立预定范畴)，作业部门即组织实施“变化点管理”——首件确认。 5.3 确认合格后，由作业部门在该批有“环”变化因素之产品流转卡上盖“变化点-环”之蓝色印章，如图: 变化点 环 5.4 是否执行生产所需的环境要求及显著影响过程结果的相关环境因素之变化点管理，由作业现场主管自查自纠;品质部和稽核室依据作业标准及工艺条件稽查。 五、相关文件 1、公司36份程序文件 2、初物管理办法 3、批次管理办法 4、质量信息管理细则 5、客户退货、在库产品质量异常出库、自制产品出库及再加工后入库处理流程及实施细则 6、自制产品和外购外协件质量异常处理流程及实施细则 7、首件样品送样作业细则 8、产品工序外协加工管理办法 9、批次质量事故解决流程 abooand t sing; three cavity two SAC tube oppression bleeding of indications, and taboo syndrome; liver puncture biopsy of indications,ndrome acute pancreatic inflammatory of difference and the General processing; Shang Digest road bleeding of emergency procesavy syns and the experiment check of features, and identification method and processing; light acute pancreatic inflammatory and hermance; liver sex brain disease, and door pulse high pressure of produced mechanism; abdominal product liquid formed of reasoperfo of identification points and the treatment; cirrhosis of onset mechanism, compensatory period and lost compensatory period ofl role and clinical role; Helicobacter pylori spiral Bacillus of treatment; Crohn's disease and ulcer sex colon inflammatory ogicaand Proton pump inhibitors of pharmacological role and the clinical application; stomach mucosa protection agent of pharmacol er pylori spiral Bacillus and gastritis and the ulcer disease of relationship; business acid agent as H2 receptor block agentmechanism, and clinical performance, and identification diagnosis, and complications and the processing; Helicobactchronic gastritis of causes, and diagnosis method, and identification diagnosis and the treatment; Digest sex ulcer of onset - 3 - 10、客户投诉、重大产品批次不良之对策措施流转顺序及对应必备手续 本标准由绩核室起草并负责解释。 本标准由绩核室归口管理。 本标准首次发布日期2009年12月12日 编制: 审核: 批准: abooand t sing; three cavity two SAC tube oppression bleeding of indications, and taboo syndrome; liver puncture biopsy of indications,ndrome acute pancreatic inflammatory of difference and the General processing; Shang Digest road bleeding of emergency procesavy syns and the experiment check of features, and identification method and processing; light acute pancreatic inflammatory and hermance; liver sex brain disease, and door pulse high pressure of produced mechanism; abdominal product liquid formed of reasoperfo of identification points and the treatment; cirrhosis of onset mechanism, compensatory period and lost compensatory period ofl role and clinical role; Helicobacter pylori spiral Bacillus of treatment; Crohn's disease and ulcer sex colon inflammatory ogicaand Proton pump inhibitors of pharmacological role and the clinical application; stomach mucosa protection agent of pharmacol er pylori spiral Bacillus and gastritis and the ulcer disease of relationship; business acid agent as H2 receptor block agentmechanism, and clinical performance, and identification diagnosis, and complications and the processing; Helicobactchronic gastritis of causes, and diagnosis method, and identification diagnosis and the treatment; Digest sex ulcer of onset - 4 -