设计与开发控制程序

与开发控制程序 文件名称 文件版本号 修订状态 页次 文件编号 设计与开发控制程序 2014年02月18日1次 A1 1/4 1. 目的:为规范设计与开发管理工作及其过程有效控制，确保产品设计开发能够满足市场或客户及有关法律法规的要求。 2. 范围:适用于本公司产品设计与开发全过程，包括产品的技术改进控制。 3. 职责: 3.1. 总经理:立项/项目设计开发批准。 3.2. 总部研究院/技术部:新产品推广/关键工艺技术执行批准。 3.3. 河南研究分院:负责产品开发策划与产品设计可行性评估，设计开发进度与费用评估，技 术拟定，样品试制，设计更改与更改验证确认。 3.4. 技术工艺科:负责总部技术文件之审查核对，本司作业参数、作业规程拟定、工装治具验 收、试作过程工艺跟踪、产品可靠性评估。 3.5. 品管科:负责材料、过程、成品检验，产品性能测试，产品可靠性评估。 3.6. 采购科:负责材料、零配件、工装治具、设备采购。 3.7. 物控科:负责产品量试、量产相应生产排定与进度跟踪。 3.8. 生产部门:负责样品试作，产品量试量产及过程作业控制。 4. 作业流程: 职责部门 流 程 作 业 简 述 ? 依据市场调研或客户要求，市场趋势或自我改进需求，分析项 立 项 客户服务部 目之可行性，并由客户服务部或研究分院提出《新产品/新项河南研究分院 目立项申请书》。申请书需明确研发背景、目的，预期目标及 完成期限，并提交总经理进行审批。 成立项目组 河南研究分院 ? 由河南研究分院领衔，成立由相关部门组成的项目组，确定项相关单位 目组负责人及各职能组成员及基本工作范围。项目组成员可包 总部研究院/技术部/品管部，或是科研合作单位。对于较大的项目组 编制项目计划 研发项目(资金1000万元以上)，项目组主要负责人须得到总 经理任命。 ? 项目责任人负责拟定《新产品开发计划书》，计划书内容应包 NO 含，项目组人员组成与分工，项目进度表，验收标准及所需的 审 批 资源与资源分配。 总经理 YES ? 项目组各成员根据《新产品开发计划书》进行设计开发。 设计开发 项目组 ? 开发之过程，应注意产品整体结构，加强不同设计模块的功能、 结构衔接配合。项目负责人适时组织各成员进行沟通总结，确 保项目的顺利进行。 NO 设计评审 项目组 ? 项目组负责项目设计评审，必要时，邀请相关单位，如设备、 品质，生产，采购等进行评审，减少设计过程风险。 YES ? 若项目由总部牵头，可按总部“设计与开发控制程序”执行。 本司保留各过程文件复本。 of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 文件名称 文件版本号 修订状态 页次 文件编号 设计与开发控制程序 2013年01月31日01次 A1 2/4 of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 责任部门 流 程 作业简述 ? 总部立项项目，依据总部下发之相关文件并结合本司之相关工 河南研究分院 编制技术文件 艺文件，编制适合本司操作之相关工艺参数及操作规程。总部 下发之适用文件，也可直接引用。 ? 本司立项项目，由研究分院负责编制技术文件。 ? 由研究分院/技术科与生产部门，共同制作(生产)样品，品研究分院 管科与技术科共同对过程/成品品质与工艺符合性进行检查。 样品试作 技术科 ? 样品试作数量:<=20AH: 10-200个 >20AH, <=65AH: 10-50品管科 个 >=65AH: 5-50个 生产部门 ? 主要验证项目为，产品性能参数、法律法规及客户要求符合性。 试验修正 ? 试作过程中出现的问题，应采取适当的矫正措施，必要时修订 技术文件(设计更改)。样品试作，可进行多次。 NO ? 试品试作结束，需对产品性能、法律法规符合性及可靠性进行项目组 样品评审 评审。评审可在项目组内部进行，必要时，可邀请相关单位(如 生产、设备、品质等)参与。品管评审内容:《测试评价》、 《测试反馈单》、评估报告。其他各部门整理汇总《不符合项 汇总表》与评估报告。 YES ? 样品通过评审后，可进入量试阶段。原则上，量试需经历如下 阶段。 技术科 量 试 1). 小试:数量200-3000个电池; 品管科 2). 中试:数量3000-8000个电池; 生产部门 3). 批试:数量8000-20000个电池 ? 量试次数依据量试状况及市场急迫状况进行一次或多次，量试 主要关注点: 1). 工艺参数确认 (技术品管负责) 设计更改 2). 工装治具操作适性确认 (生产单位负责) 3). 生产效率确认 (生产单位负责) 4). 材料用量确认 (技术负责) 总部项目组 5). 产品性能确认(技术品管负责) NO 本司评审小组 评 审 ? 量试(试生产)完成后，须在二周内进行设计确认评审。 ? 评审之相关要求，见“补充作业说明”。 YES 总部项目组 ? 当评审通过后，由项目组负责对关键参数(性能)要求进行标准技术科/品管科 化，以作量产指导作业。 标准化 ? 量产采取逐步加量方式进行，一般首次量产，以20000-50000 个电池为宜，第二次可加倍，以便修正(设计更改)量产过程物控科 中可能出现的偏差或问题。经二次量产后，可正常大批量生产。 量 产 生产部门 ? 注:对于特殊用途之产品，由于市场需求量小，量试与量产数 量，可相应减少。新品通过营销运作，推向市场。报废品走公 司相应报废流程。 文件名称 文件版本号 修订状态 页次 文件编号 of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 设计与开发控制程序 2013年01月31日01次 A1 3/4 5. 补充作业说明: 5.1. 立项评估: 《新产品立项申请书》应包含立项来源(市场调研，客户需求，市场趋势或产品升级 需求等)，产品特性、价格、销路，市场规划，技术开发能力，开发时间表及成本价格预 算等。 当项目来源总部时，由总部执行。 5.2. 设计输入要求:应包括 1). 总体设计:外形，性能，功能描述; 主要技术参数和性能指标。 2). 适用的相关标准，法律法规，顾客特殊要求以及社会、市场要求。 3). 图面设计，所需的材料、配件设计。 4). 先前类似设计的有关要求，设计开发所必须的其他要求，如安全、防护、环境等方面的 要求。 5.3. 设计输出要求: 1). 项目组成员，应依据《新产品开发计划书》之进度表要求进行设计活动，编制相应的设 计输出文件，确保一产品相关的原料采购，生产、储存、搬运、验收、使用、维修、处 置及安全性相关的重大设计特性已明确或做出标识，且满足设计输入要求。 2). 输出文件应包括相关产品图纸、模治具图纸、包装设计图纸，用料清单，材料/半成品/ 成品技术条件及各过程检验要求。 3). 设计输出文件初稿，应由项目组负责人批准后方可发放。 5.4. 设计评审 1). 设计初稿全部完成后，由项目负责人，召集所有参与设计开发之人员，必要时可邀请各 单位代表/客户代表/总部人员或合作科研单位专家等，对所设的所有参数、相关图纸， 再进行综合性、系统性的检查。另，对产品标准的综合性，采购的可行性，加工的可操 作性，结构的合理性、美观性等方面进行检讨，并对设计的缺陷和不足采取相应的纠正 或改进措施。 2). 项目组根据评审的内容和结果，整理出《设计评审报告》，并作出评审结论及应采取的 改进措施，呈总经理批准。 5.5. 设计确认评审: 1). 设计确认评审小组包含: a). 总部项目组:组成部门与人员由总部确定。 b). 本司评审小组:研究分院、技术科、品管科、生产部门相关项目负责人，必要时包括 物控科与设备科及采购科/财务科。 2). 评审时必须提供之资料: a). 试生产工艺确认报告(含材料报告)。 b). 工装治具验收报告 c). 问题与解决措施及时间表 of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 文件名称 文件版本号 修订状态 页次 文件编号 设计与开发控制程序 2013年01月31日01次 A1 4/4 3). 评审重点: a). 设计结果与目标比较 b). 批量生产可行性 c). 检测验收可行性 d). 产品安全性 e). 产品可靠性 4). 评审结论: a). 通过:可以量产 b). 不通过:进行设计更改 5.6.设计更改: 1). 更改时机: a). 样品试作、量试、量产等过程中，实际结果与设计要求不符，操作性不佳，效率太低等 b). 正常生产过程中，为提高操作性/生产效率等; 因新设备引入或操作环境改变等。 c). 客户要求或是法律法规要求 d). 为提升客户满意度，而变更外观/包装等设计，提升性能要求或是安全性要求等。 2). 操作程序: a). 由变更需求部门提出变更申请(工作联络单)，技术科审核并拟定临时试验要求，生产 试行，品管科与技术科跟踪验证。 b). 经试验验证后，由技术科结合相关的数据及各部门(含研究分院)的建议意见，编写更 改验证报告，相关部门进行会签审核。审核通过后，予标准化执行。 6. 标准化: 6.5.在量试之设计确认评审后，量产前，技术科应对相关的工艺参数及操作规程标准化(下发 正式的标准文件)。 6.6.各过程之设计更改临时文件，原则上最大执行期限为3个月。3个月后，若更改不可行，需 执行原工艺，技术科应撤消临时文件或再次更改试行; 当确认更改方案可行后，技术科应将 更改标准化。(当下文进行更改后，实际因试产很少，未能确认参数，可适当延长试用期) 7. 相关文件/表单: of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 文件名称 文件版本号 修订状态 页次 文件编号 设计与开发控制程序 2013年01月31日01次 附1/1 A1 附:文件审核与会签责权表 1. 新产品或新项目应用 1.1. 样品试制试验 项 目 主 导 审 核 会 签 核 准 工艺审核 技术 技术 样品制作 技术 数据收集与报告撰写 技术 技术 技术 结果评审 技术 技术 生产/品管 技术 1.2. 批量试制(小试、中试、批试) 项 目 主 导 审 核 会 签 核 准 工艺审核 技术 生产/品管 技术 样品制作 技术/生产 技术 生产/品管 技术 数据收集与报告撰写 1).生产:不良率，生产效率，可操作性等 生产 2).过程检测数据，不良分析，产品基本性技术 技术 /品管 技术 能符合性测试 3).关键指标测试，可靠性试验与评价 结果评审 技术 技术 生产/品管 总经理 1.1. 量产 项 目 主 导 审 核 会 签 核 准 推广评审 技术 技术 生产/品管 总经理 工艺审核 技术 生产/品管 技术 生产运行 生产/品管 数据收集与报告撰写 1).生产:不良率，生产效率，可操作性等 生产 2).过程检测数据，不良分析，产品基本性生产/技术 技术 /品管 技术 能符合性测试 3).关键指标测试，可靠性试验与评价 生产/品管/应用评审 技术 技术 总经理 其他 2. 工艺变更 项 目 阶段 审 核 会 签 核 准 缩小偏差，提升一致性之变更 试验 技术 技术 生产环境控制，保障产品一致性 推广 技术 技术 产品品质或一致性筛选 试验 技术 技术 一般性的产品参数变更、生产与设备条件变 更 推广 技术 技术 生产/品管(科关键/特殊工序参数变更 试验 技术 技术 长以上) (铸板温控参数，和膏参数，固化条件，铸生产/品管(副焊工艺，化成工艺，配组工艺) 推广 技术 技术 总或总助) (注:工艺试验后，推广前，应由技术收集生产/品管/技术相关数据，并形成报告(保留 of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled 原始)，会签各部门进行审查) of forms to conduct extensive publicity and education of the masses, so everyone pay attention to fire prevention. 2, it is forbidden to take a flammable building, not allowed to pile up any stuff under the power lines, no flammable materials in winter insulation, acetylene and oxygen cylinders must be put in storage for storage. Lighting Route 3, on-site erection, installation of electrical equipment, must be made by the official electrician, prohibited the use of electric heating, cooking, water heating, such as when you must use a furnace must be approved by the Security Department, after licensing ... Not affecting local residents ' life and rest. 3, other pollution prevention (1) advanced construction equipment used in construction, and to take effective measures to control dust, emissions, noise, vibration, pollution and harm to the environment. Reasonable arrangement, reducing night-time construction, actively cooperate on environmental protection and environmental protection departments. (2) because of their construction, such as water, electricity must apply for approval in advance, caused by the damaged public roads should be repaired in time, waste, rubbish should be cleared up, site formation, drainage is good, work is finished, clean and clear. (B) sanitation works management divided into several segments, segment contract, establish areas of responsibility. Construction site provides daily cleaned and kept in a clean and sanitary, site leveling, assorted goods neatly stacked, smooth road flat, without stacking, fallout, no water retention, no black-odor, zero waste, drainage facilities, separation of garbage and construction waste piled