生产过程管理程序.docVIP

生产过程管理程序Production Process Management Procedure1.0 目的Purpose 制订生产控制程序,确保公司产品能按质、按量及按期完成。To setup a Production Process Management Procedure to ensure products meet requirements of quality, quantity and OTD.2.0 范围 Scope 本程序适用于公司所有产品的生产过程控制。This procedure is applicable to all manufacturing process control for product in XXX. 3.0 职责 Responsibilities3.1 生产部经理负责协同本部门人员制订、优化本控制程序，并监督其运行, 对生产过程的管理负责。 Production managers are responsible for production process management including development and optimization of this procedure and the monitoring of its performance with all the staffs of the departments.3.2 生产计划员负责制定物料计划和生产计划，并跟踪、协调计划之实施，必要时负责和市场部或客户进行沟通。PMC is responsible for development and maintenance of material plans and production plans, and to communicate with the marketing department or customers when necessary.3.3 生产部工艺工程师负责工艺开发、标准工时的维护、工艺文件（比如：PFMEA、process Flow chart、控制计划CP、随工单、工艺标准、作业指导书、过程控制图表等）制定及更新并对员工进行培训、指导，并负责分析过程受控趋势及调查工序不受控的原因。必要时工艺工程师可取得跨部门小组（包括工程、设备管理、质量管理等相关职能人员）的支持。 工艺工程师还负责识别过程关键特性并形成控制计划，对后序阶段不能充分验证符合性时，识别过程验证点。PE (Process engineers) are responsible for process development, standard labor hours maintenance, preparation and initiating or updating process documentations (including PFMEA, Flow chart, Control Plan, traveler, in-process inspection criteria, working instruction and visual aids, process control chart etc.)，and operator training and qualification. It is also PEs responsibility to analyze process trend and investigate the reason that unsatisfied trend or point is out of control. PE can get support from Cross Functional Team (engineering, equipment, quality etc.) when requested.PE shall identify process key characteristics and develop the control plan, identify the in-process verification points. Where the conformity of product cant be verified by sequence process, process verification shall be defined.3.4 生产部设备工程师负责本部门所有设备的维修及管理，包括设备/工装夹具清单、设备验收、设备操作作业指导书和日常维护保养计划的制定及设备操作指导和培训，同时，及时对非计划停机的应急处理外部设备供应商沟通。对于检测设备须按照监视和测量设备控制程序的要求，按照规定的时间送计量室做校准处理。Equipment Engineers are responsible for equipment management, including routine maintenance and repairs, operating instructions, handling of sudden shut downs, etc. The calibration of measuring equipment shall be conducted in accordance with the requirements specified in Monitoring & Measuring Equipment Management Procedure. 3.5 生产主管负责按照生产计划安排生产，监控生产过程中的安全、质量、准时交付率、在制品控制（批次和可追溯性、不合格品隔离等）及生产效率，确保操作人员得到适当培训的情况下进行生产，且所有生产和检验的记录归档保存；维持生产现场的5S有序状态及处理生产过程中的偶发事件；会同PMC和市场部进行订单评审。 Production supervisors are responsible for safety, quality, on time delivery and WIP control （such as lot control & traceability, isolation of non-conformance materials etc.）as well as production efficiency, Production supervisor shall make sure operators are trained before starting the production , and production and test records is archived. 5S compliance and handle all issues arising from production. Production supervisors shall provide support to PMC and the marketing department to perform order reviews.3.6 生产拉长直接监督标准化操作的符合性，协助生产主管对生产现场进行管理，及时纠正或向上级报告现场发生的问题。Production line leaders and assistant line leaders are direct monitoring of SOP compliance and support production supervisors to implement production management on line. Their duties include rectifying and/or reporting all production issues when they occur on the production line.3.7 所有操作员应该按照作业指导进行相关作业操作，按工艺要求记录相关生产信息，比如：生产数据、生产过程控制图表等，并有责任对所用机器、设备、仪器进行日常检查维护,及时反馈该机器、设备、仪器之状态。Operators shall work in accordance with relevant working instructions，and record process information e.g. production data and process control chart according to process requirements. Operators have responsibility to perform the daily check of the machinery, equipment and measuring equipments and shall report the status to the responsible supervisors in a timely manner. 3.8 物料员负责生产物料的管控、生产线盘点。Material handler is responsible for production material management and the physical inventory of material on the production line.3.9 品质部人员负责产品检验的实施，并对生产过程实施制造过程审核，针对审核发现协同相关部门进行持续改善。Quality department is responsible for conducting internal process audits and to follow-up on corrective action implementation in order to drive process improvement. IQA is responsible to confirm incoming material quality and to share data with suppliers for the purpose of quality improvement.3.10 仓管员负责物料和成品、半成品出入库操作，以及在库品管控。Warehouse clerks are responsible to manage materials, subassemblies and finished goods flow in warehouse and to verify quantities.3.11 对于ISO/TS16949汽车产品、ISO13485医疗产品、AS9100航空产品的分层审核的职责和运作见WI-QA-0219 分层制造过程审核。The responsibilities and operation of Layered process audit related to ISO/TS16949 automatic products, ISO13485 medical products, AS9100 aerospace products, please refer to WI-QA-0219 “Layered Process Audit”.3.12 对于AS9100航空产品的批次管理的职责和运作见WI-QA-0237 产品批次管理。The responsibilities and operation of product Lot/Batch Management related to AS9100 aerospace products, please refer to WI-QA-0237 “Lot/Batch Management”.4.0 相关文件 Reference Documentations 4.1 XXX-QP-05基础设施管理程序 “Infrastructure Management Procedure”4.2 XXX-QP-06设备管理程序 “Equipment Management Procedure”4.3 XXX-QP-07工装管理程序 “Fixture and Tool Management Procedure”4.4 XXX-QP-08新产品开发程序 “New Product Development Procedure”4.5 XXX-QP-13合同评审程序 “Contract Review Procedure”4.6 XXX-QP-14顾客财产管理程序 “Customer Property Management Procedure”4.7 XXX-QP-18监视和测量设备控制程序“Monitoring and Measuring Equipment Control Procedure”4.8 XXX-QP-22最终检验程序 “Final Inspection Procedure”4.9 XXX-QP-23不合格品控制程序 “Nonconforming Product Control Procedure”4.10 XXX-QP-21标识与可追溯性管理程序“Identification and Traceability Management Procedure”4.11 XXX-QP-20货仓管理程序 “Warehouse Management Procedure”4.12 XXX-QP-17进料检验管理程序 “Incoming Material Inspection Management Procedure”4.13 XXX-QP-02记录管理程序 “Record Management Procedure”4.14 XXX-QP-31更改控制程序 “Change Control Procedure”4.15 XXX-QP-33 工艺验证程序 “Process Validation Procedure”4.16 XXX-QP-34技术状态管理程序 “Configuration Management Procedure”4.17 WI-QA-0219 分层制造过程审核 “Layered Process Audit” Working Instruction4.18 WI-QA-0237产品批次管理作业指导书“Lot/batch Management” Working Instruction.5.0 定义 (略) Definitions （Omit）6.0 运作程序 Operations6.1 物料计划及生产计划Material Plan and Production Plan 6.1.1 订单物料的评审，生产计划员收到市场部的产品订单通知后,首先查询库存是否有符合订单要求的成品或物料,再确认订单交货期,以便安排生产及出货计划.Material Order Review: Upon receipt of an order from marketing, the PMC shall verify existing stock of finished goods or materials. Based on these stock levels, the delivery time is confirmed and production and shipment plan is arranged. 如货仓有符合要求的未分配给其他客户的产品,且库存数大于或等于订单数,包装也符合订单要求，确认交付期为订单需求日期。If the inventory of available finished goods in the warehouse i.e. not earmarked for other customers and packed according to customer requirements exceeds the order quantity, the delivery date can be confirmed as specified in the order. 如货仓无符合要求的成品，或符合要求的未分配给其他客户的成品库存小于订单数, 生产计划员与采购确认物料到货期，并与生产负责人沟通根据生产能力确认交付期,并反馈给市场部。If there are not finished goods in warehouse or the inventory of available finished goods in the warehouse i.e. not earmarked for other customers and packed according to customer requirements is less than the order quantity, the PMC shall verify incoming material availability, confirm the delivery date with the Production Manager and advise marketing accordingly.6.1.2 生产计划，生产计划员根据市场部承诺的交期及现有的生产负荷制定生产计划；如订单部分要求有更改，生产计划应以最新的更改为准。Production Plan: The PMC develops the production plan in accordance with agreed delivery dates and production capacity. The plan may be revised from time to time due to changes in customer delivery requirements.6.1.3 物料需求计划:ERP根据生产计划生成主生产物料（在BOM中列明的物料）的需求计划. 对于不在BOM中的生产辅料，由生产部、品质部、仓库向生产计划员提出相关物料需求，生产计划员汇总物料采购需求后提交给采购部采购。Material Request Plan: ERP automatically generates the material request plan based on the production plan and related BOM. For general materials used in production not specified in BOM, Production, Quality and Warehouse shall submit the requirements to PMC, who gather the information and makes the request to the purchasing department. 备注：对Lead Time较长且需求量稳定的重要物料, 生产计划员须根据市场服务部提供的 forecast、现有库存情况、物料采购周期、物料损耗、未到货物料情况等制定物料订购预测提供给采购以便供应商提前准备物料。常规生产物料(BOM)需求计划，生产计划员对将要生产的产品所需要的物料做以下查询:Remark: PMC function shall forecast the consumption of materials with long order lead times and those materials consistently used for specific products in production. This purchase forecast shall be based on marketing forecasts, inventory data, purchase lead times, consumption, materials in transit, etc. Purchasing may ask vendors to prepare these materials in advance. For generic production materials in BOM, the Production Planner should consult the following information: 根据S/O的产品型号找出相应的经工程部签发的产品物料清单(BOM)；According to the Sales orders to find related BOM.查询BOM中每项物料的库存数，特殊要求物料的库存数；Existing inventory of standard materials in BOM and special materials e.g. customer supplied etc. 查询采购订单交货记录, 该产品物料交付数.对有特殊要求的物料, 工程部需确认物料号并通知生产计划员, 必要时需提供相关的工程确认文件。Purchase orders and material receipt history. For special material, Engineering shall supply PMC the part numbers and engineering documentation, where necessary. 6.1.4 物料采购，采购员依据ERP报告或PMC提出的采购需求做物料采购动作; Material Purchasing: The buyer shall make purchases in accordance with the ERP report and PMC requirements.6.1.5 物料计划跟踪，采购员负责跟进物料的交付日期（供应商OTD）和质量情况，并反馈任何可能影响到准时交付的异常。Material Receipt/Quality: The buyer is responsible for supplier OTD and quality status and should advise PMC of any extraordinary case that affects lead times and delays in supply.6.1.6 生产计划的跟踪，生产计划员和生产主管适时对生产进度和质量状况进行跟进，对任何可能影响到交付的情况予以及时纠正。必要时取得相关部门的支持，或报告给管理层。Production Plan Monitoring: PMC and the Production Supervisor shall monitor the production and quality and take the corrective actions necessary to resolve any issues that effect material lead times. Related departments may be requested to help or report issues to management, if necessary.6.1.7 如果需要对物料、生产计划及交货期进行变更时，必须经过相关部门的协商，必要时需取得客户的同意后方可进行相应的更改。If requiring for changes in the schedule of material, production and lead time, the appropriate department will be called upon the request of approval and get customer approval if needed. 6.1.8 依据市场策略或战略的需要，ERP系统对不同产品类型设定成品或物料的安全库存The ERP system will be used to establish responding needed safety stock levels for finished goods and raw material in accordance with the marketing strategy.6.2 产能的管理Production Capacity Management :6.2.1 产能的计划，市场部依据过往经验数据以及市场策（战）略提供合理的forecast, 每年末生产经理根据来年的forecast和其它相关信息作出合理的部门费用预算和固定资产预算。 应市场变化的需要，forecast是动态更新的，故其它方面的准备工作也需根据实际情况作相应的调整。esponding needed ing needed compliance and e productskloop.cedure Production Capacity Plan: Marketing provides a sales forecast based on the marketing strategy and their experience. The Production Manager provides an annual budget of departmental expenses and capital expenditures at the end of each year. This sales forecast is dynamic and can be updated with changes in market and the affect on other resources. 6.2.2 生产主管要根据预期需求做人员上的准备，并依据岗位需求做能力和SOP等方面的培训. Production supervisors shall determine and allocate adequate manpower, and train and qualify operators in accordance with determined STD Cost.6.2.3 标准工时的测量，工艺工程师需要对产线进行时间分析和动作分析，制定标准的操作方法，制定标准工时, 以备标准成本核算和日后生产效率统计之用。 Standard Hours Measurement: Production engineers shall analyze operational time consumption and process flow in order to establish the SOP and standard hours for cost and efficiency statistical analysis purposes.6.2.4 PE负责提出工艺更改需求，评估更改可行性并将之文件化。见更改控制程序 PE is responsible for process change request, evaluation feasibility and documented the change.6.2.5 生产能力评估 Production Capacity Assessment当评价生产能力的潜力时，在开始新设备计划之前，生产部门应当首先看是否可以基于目前的设备产能通过优化操作/运作来达到期望的产能。When evaluating capacity potential, the manufacturing team shall first look at current level of operational optimization before starting capacity for capital equipment planning.工艺工程师和生产主管依据生产效率的统计结果，对生产过程进行分析和改进，包括合格率产量数据、资源利用情况、班次提供、标准操作、员工培训有效性等方法.Process engineer and production supervisor analyzes production efficiency statistics; yield data, utilization, shifts available, SOP and training effectiveness in order to improve processes to increase production capacity.在产品投放到生产线之前, 工艺工程师根据相关原则布置生产线.如避免无效率运作原则、保证安全的原则、符合环境和其他法规原则、提高员工舒适度的原则等等. Prior to production, process engineer shall design production line layouts to maximize efficiency, comply with relative regulations and environmental requirements and to improve operator productivity and working conditions.布置方案的分析与确定，工艺工程师在明确所要生产的产品(product)、数量(quantity)、工艺流程( routing )、辅助劳务(supporting service)与时间(time) 等信息后,根据以上原则, 制定出初布置方案。在后续的生产过程中进行物流分析、 工序流程分析、 生产柔性分析和设备性能与加工能力分析不断优化布置方案. Layout development and confirmation: Process engineer shall obtain relative production information e.g. product, quantity, routing, support services, schedules, etc. with which to design the layout plan. In order to optimize efficiency, a continuous improvement program shall be implemented to enhance the transportation flow, process capability and effectiveness, production flexibility and equipment performance.6.3 产前准备Preparation Before Production :6.3.1 PMC根据ERP系统需求制定生产计划并开具工单，给出Work Order号。PMC generates a work order based on the ERP production plan and releases WO number.6.3.2 PE对工艺开发进行验证，见工艺验证程序。 PE performs process validation prior to production. Please refer to Process Validation Procedure.对于AS9100特殊工艺在使用前按照相关客户的要求得到确认和授权批准。For special process quality system, special process shall be validated and approved by authority prior to production in accordance with related customer requirements. 6.3.3 生产文件准备 Preparation of Production Document生产文件在生产前应得到批准，按需要，生产文件应包括：图纸、工艺流程卡、控制计划、随工单、设备工艺参数、操作作业指导书和工艺检验标准文件。Production documents shall be approved prior to performing production, where applicable, production documents shall include: related drawing, process flow chart, control plan, traveler, process data, operation working instruction and process inspection documents.对于AS9100航空质量体系要求的产品，工艺标准和作业指导必须以最清楚实用的方式来规定，如非常具体的书面标准、代表性的样品或清晰的图示说明。适用时，对外来物的防止、检测和去除的规定应被识别，作为工艺标准考虑或作业指导书的一个组成部分。For AS9100 certified products, criteria for workmanship and working instructions shall be stipulated in the clearest practical manner, e.g. written detailed standards, representative samples or illustrations or visual aids. Where applicable, provision for the prevention, detection and removal of foreign objects shall be identified and defined into related criteria and corresponding working instruction. 6.3.4 人员能力和培训 Personnel competence and Training生产管理人员将准备就绪生产的产品的生产文件放至相应的员工易于获得工位，操作员工应在生产前 具备相应的操作能力或得到相应上岗前培训。对于AS9100定义的特种工艺操作人员，需经过指定特种工艺程序考核批准方能上岗。对于客户有操作人员眼睛视力要求的，还应对操作人员视力水平考核认可。Production management personnel shall release production document and place in appropriate stations with easily accessible position. The operators shall have been qualified with operation competence or get training prior operation.For AS9100 defined special process, operators shall be qualified and approved by authorized person according to specified special process requirements prior to operation. Where required by customer on vision of operator, the operator should also be assessed the level of visual qualification.6.3.5 物料员依据工单准备领料单，领料单经相关人员批准后，物料员可到货仓领料；对领取的物料进行状态和数量确认，确保其和领料单上的型号、(如果有要求的话，批次号)、数量一致，并且信息完整（如有效期、RT号和RoHS标识、IQA检验标识等等）；确保物料在搬运中得以适当的防护、标识。Material handlers shall prepare a material requisition note and obtain necessary approvals. Material handlers bring the material from the warehouse, check the current condition and count （where applicable, Lot number）, confirm the part number, quantity, expiration date, RT number and ROHS compliance status against the approved material requisition note, verify the IQA inspection label is correct and ensure the material is protected and identifiable during transportation. 6.4 设备、工装的准备，根据即将生产的产品型号将相应的工装按规定放置相应的工位，并依据工艺文件的规定设定相关设备参数。具体见设备管理程序。Equipment/Fixture Set-up: Place fixtures and equipment in the appropriate location, set-up parameters in accordance with relative WI and compare the first part with the last part in batches to ensure consistency, if necessary. Details please refer to “Equipment Management Procedure”6.5 生产过程控制Production Process Control 6.5.1 员工依据工艺文件及标准化操作的要求实施产品加工，确保不会将不合格的产品流入下道工序，必要时需要对自己加工的产品进行确认，并做好相应的质量记录（如流程单上的相关记录等）。如有防静电、净化度、照明光线等要求时，参照基础设施管理程序进行。Operators build product according to the WI and SOP, prevent nonconforming product from passing on to subsequent stations, re-inspect for conformance when necessary, and maintain process/quality documents such as travelers. For ESD， cleanliness or lighting requirements, refer to the “Infrastructure Management Procedure”.6.5.2 员工有责任依据设备管理人员制定的日常点检（保养）计划进行力所能及的设备保养工作，并在设备异常时报告相关管理人员和设备工程师处理。员工有责任点检自己所使用的计量仪器到期情况，有到期仪器及时向主管或设备工程师报告。In accordance with WI, operators conduct daily equipment checks and simple maintenance and check expiration dates of instruments. Any extraordinary circumstances should be reported to production management and Equipment engineer as appropriate.当有多个班次生产时，生产经理需在每个班次指定相关负责人，并规定出现问题时的报告方式，确保现场出现的问题能得到及时的解决。When production is carried out on multiple shifts, production managers shall appoint a Shift Leader for each shift responsible for reporting irregularities on the line to ensure timely resolution and correction.生产主管和拉长需对员工的操作及生产过程中出现的各种异常现象进行监控和实时纠正，保证生产过程得到合适的监控如安全生产、合格率、5S、SOP、生产效率、WIP、质量记录等方面。当出现合格率明显异常需要技术支持或超出已建立的停产控制线的情况时，现场管理人员需要通知工艺工程师处理（改进需求提案），有必要时告知生产经理做临时停产处理。Production supervisors and line leaders monitor the production processes to insure proper in safety, yields, 5S, SOP, production efficiency, WIP, quality records, etc. and correct any irregulari