07工艺及物料管控案例.pptx

工艺及物料管控 - 设计输出到工程实现 2014-8-1516;课程计划;课程目标;内容;一.为什么谈这个问题？;在1C的试产装配的机器中，用于可靠性的机器12#，13#出现杯盒在上料过程中杯盒翻落。 故障时机：可靠性测试阶段 通过测量，杯盒的缺槽的两端的尺寸分别为120.17mm和119.63mm，少于理论尺寸121.74mm。两者相差分别为1.57mm和2.11mm。另外此杯盒中心宽度凹陷更多，尺寸为118.02mm。 结论：杯盒尺寸超差。 研发没有要求供应商重点控制此尺寸，早期物料不受控。 ;自动装载机构下料失败，盒子右边沿与钣金件干涉。 故障时机：可靠性测试阶段 结论：此批机器在装配时，均未使用下料调节夹具（BM10-J30）装配调节。调节不到位，导致卸料盘与横梁间间隙小引起。 工艺文件没有落实。 ;还有多少潜在的工艺、物料问题？;产品的质量和可靠性;内容;FDA 483 Observation; MRSZP05N01 Product Design Development Procedure Design outputs that are essential for the proper functioning of the product shall be identified either in the design outputs index or “Input/output tracking matrix”. MRSZP05N13 Design Outputs Procedure(MPI) ? 识别并记录维持器械正常工作的基本设计输出。 Identify and document the design outputs that are essential for the proper functioning of the device. ? 基本设计输出应该考虑到所有专业方向，应识别出包括软件，硬件，机械，系统，气体等方向中与设备 相关的基本设计输出。 The document shall consider all of the Design Outputs from all of the functional engineering groups (software, hardware, mechanical, systems, pneumatic, etc.) and shall identify those that are essential to the proper functioning of the device. 基本设计输出应该包括产品规格及用户接口特性（可参考操作手册）的子集。这个子集的选择标准应为 ：这些输出定义了设备的基本功能。 The Essential Design Outputs may be comprised of a subset of Product Specifications and User Interface features (as contained in the Operator’s Manual). Selection criteria shall be those outputs that define essential functioning of the device. ?Remain the basic requirement ; (d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approv