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检验控制程序Inspection Control Procedure（ISO9001：2015）1目的Purpose本程序的主要目的是根据公司质量策划安排对产品的特性进行检验，以验证产品要求已得到满足。
The main purpose of the procedure is that acc. to company quality planning to implement inspection of product property, to validate that the product requirement has been complied.2适用范围Application Scope本程序文件主要是适用于公司采购、外协加工的材料、半成品和成品等进货产品的检验；各车间生产过程中产品和工序的检验；以及最终产品的检验。
The procedure is mainly applicable for the incoming inspection of the company purchased material and out-sourcing material, semi-product and finished product; the inspection of various factory processes and productions and delivery inspections.3规范性引用文件Normative Documents下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注日期的引用文件，其随后所有的修改单（不包括勘误的内容）或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件，其最新版本适用于本标准。
The clauses in the following documents will become the clauses of the standard viathe quote of the standard. All the quoted documents with date, all the future changes form(corrected contents excluded) or the revise editions are not applicable to the standard. While, encourage the parties who has had an agreement acc. to standard to study whether can use the latest version of these documents. All quoted documents which not notes the data, the latest version is applicable to the standardISO9001：2015 质量管理体系要求9.1产品的监视和测量ISO9001：2015 Quality Management System Requirement 9.1 Production Monitoring and Measurement4术语和定义Terms and Definitions本程序采用GB/T19000中确定的的专业术语。
Page: 1/6Status:PREOCEDURE 程序文件Quality Control Procedure 品质控制程序__________________________________________________________姓名Name职位Position签名Sign日期Date编写Author 审核 Reviewers 批准 Approval分发Diffusion 人事部 HR品质部 QA船务部 SH生产部 PRO.采购部 PUR.财务部 FA.开发部 PD.货仓部 WH.管代 M.R. 总经理 GM接收人Applicable to版本号Version 日期 Date 修订描述Modification description修订人 By A0 2010-01-18 无/目的OBJECTIVE 2 范围SCOPE 2 职责RESPONSIBILITY 2 正文PROCEDURAL ELEMENTS 3 流程图FLOW CHART(S) 3 任务描述TASKS DESCRIPTION5引用文件REFERENCE DOCUMENTS 6 定义及缩写DEFINITIONS/ ABBREVIATIONS 6 记录RECORDS 6__________________________________________________________ 关键字Key words:品质控制Quality ControlPage: 2/6Status:PREOCEDURE 程序文件Quality Control Procedure 品质控制程序__________________________________________________________Objective 目的Ensure quality control in process are efficiently and effectively inspected. 确保制程中品质控制有效。
产品质量先期策划与控制计划英语In the ever-evolving landscape of business, the cornerstone of success lies in the meticulous craftsmanship of quality products. Quality Planning and Control, often abbreviated as QPAC, is a strategic approach that ensures the delivery of products that not only meet but exceed customer expectations. It's a proactive measure that involves a systematic process of defining, implementing, and maintaining quality standards from the inception of a product idea to its final delivery.The journey of QPAC begins with a deep dive into customer needs and expectations, which is the heartbeat of any product development. By understanding the market and the end-users, companies can tailor their products to satisfy specific demands and preferences. This understanding is thentranslated into a robust design and development plan, where every detail is scrutinized for its impact on quality.As the product moves from the conceptual stage to the tangible reality, the control plan comes into play. It's a dynamic document that outlines the steps taken to ensure the product is manufactured to the highest standards. It includes everything from the selection of raw materials to the final inspection before the product leaves the factory. Each stepis meticulously monitored and controlled to prevent any deviation from the set quality benchmarks.The beauty of QPAC lies in its ability to anticipate and mitigate potential issues before they escalate. By implementing a robust system of checks and balances, companies can ensure that the final product is of the highest quality. This not only enhances customer satisfaction but also builds a reputation for excellence that is invaluable in today's competitive market.Moreover, QPAC is not a one-time event but a continuous process of improvement. As new technologies emerge and customer needs evolve, the control plan must adapt accordingly. This agility allows companies to stay ahead of the curve and maintain their competitive edge.In conclusion, the art of Quality Planning and Control is a symphony of precision, foresight, and adaptability. It's a testament to the commitment of businesses to deliver excellence and a promise to customers that they will receive nothing but the best. It's a practice that, when embraced, can elevate a product from good to great, and a company from average to exceptional.。
QE=品质工程师（Quality Engineer）MSA: Measurement System Analysis 量测系统分析LCL: Lower Control limit 管制下限Control plan 管制计划Correction 纠正Cost down 降低成本CS: customer Sevice 客户中心Data 数据Data Collection 数据收集Description 描述Device 装置Digital 数字Do 执行DOE: Design of Experiments 实验设计Environmental 环境Equipment 设备FMEA: Failure Mode and Effect analysis 失效模式与效果分析FA: Failure Analysis 坏品分析FQA: Final Quality Assurance 最终品质保证FQC: Final Quality control 最终品质控制Gauge system 量测系统Grade 等级Inductance 电感Improvement 改善Inspection 检验IPQC: In Process Quality Control 制程品质控制IQC: Incoming Quality Control 来料品质控制ISO: International Organization for Standardization 国际标准组织LQC: Line Quality Control 生产线品质控制LSL: Lower Size Limit 规格下限Materials 物料Measurement 量测Occurrence 发生率Operation Instruction 作业指导书Organization 组织Parameter 参数Parts 零件Pulse 脉冲Policy 方针Procedure 流程Process 过程Product 产品Production 生产Program 方案Projects 项目QA: Quality Assurance 品质保证QC: Quality Control 品质控制QE: Quality Engineering 品质工程QFD: Quality Function Design 品质机能展开Quality 质量Quality manual 品质手册Quality policy 品质政策Range 全距Record 记录Reflow 回流Reject 拒收Repair 返修Repeatability 再现性Reproducibility 再生性Requirement 要求Residual 误差Response 响应Responsibilities 职责Review 评审Rework 返工Rolled yield 直通率sample 抽样,样本Scrap 报废SOP: Standard Operation Procedure 标准作业书SPC: Statistical Process Control 统计制程管制Specification 规格SQA: Source(Supplier) Quality Assurance 供应商品质保证Taguchi-method 田口方法TQC: Total Quality Control 全面品质控制TQM: Total Quality Management 全面品质管理Traceability 追溯UCL: Upper Control Limit 管制上限USL: Upper Size Limit 规格上限Validation 确认Variable 计量值Verification 验证Version 版本QCC Quality Control Circle 品质圈/QC小组PDCA Plan Do Check Action 计划执行检查总结Consumer electronics 消费性电子产品Communication 通讯类产品Core value （核心价值）Love 爱心Confidence 信心Decision 决心Corporate culture (公司文化)Integration 融合Responsibility 责任Progress 进步QC quality control 品质管理人员FQC final quality control 终点品质管制人员IPQC in process quality control 制程中的品质管制人员OQC output quality control 最终出货品质管制人员IQC incoming quality control 进料品质管制人员TQC total quality control 全面质量管理POC passage quality control 段检人员QA quality assurance 质量保证人员OQA output quality assurance 出货质量保证人员QE quality engineering 品质工程人员FAI first article inspection 新品首件检查FAA first article assurance 首件确认CP capability index 能力指数SSQA standardized supplier quality audit 合格供应商品质评估FMEA failure model effectiveness analysis 失效模式分析AQL Acceptable Quality Level 运作类允收品质水准S/S Sample size 抽样检验样本大小ACC Accept 允收REE Reject 拒收CR Critical 极严重的MAJ Major 主要的MIN Minor 轻微的Q/R/S Quality/Reliability/Service 品质/可靠度/服务P/N Part Number 料号L/N Lot Number 批号AOD Accept On Deviation 特采UAI Use As It 特采FPIR First Piece Inspection Report 首件检查报告PPM Percent Per Million 百万分之一SPC Statistical Process Control 统计制程管制SQC Statistical Quality Control 统计品质管制GRR Gauge Reproducibility & Repeatability 量具之再制性及重测性判断量可靠与否DIM Dimension 尺寸DIA Diameter 直径QIT Quality Improvement Team 品质改善小组ZD Zero Defect 零缺点QI Quality Improvement 品质改善QP Quality Policy 目标方针TQM Total Quality Management 全面品质管理RMA Return Material Audit 退料认可7QCTools 7 Quality Control Tools 品管七大手法通用之件类ECN Engineering Change Notice 工程变更通知(供应商)ECO Engineering Change Order 工程改动要求(客户)PCN Process Change Notice 工序改动通知PMP Product Management Plan 生产管制计划SIP Standard Inspection Procedure 制程检验标准程序SOP Standard Operation Procedure 制造作业规范IS Inspection Specification 成品检验规范BOM Bill Of Material 物料清单PS Package Specification 包装规范SPEC Specification 规格DWG Drawing 图面系统文件类ES Engineering Standard 工程标准IWS International Workman Standard 工艺标准ISO International Standardization Organization 国际标准化组织GS General Specification 一般规格部类PMC Production & Material Control 生产和物料控制PCC Product control center 生产管制中心PPC Production Plan Control 生产计划控制MC Material Control 物料控制DCC Document Control Center 资料控制中心QE Quality Engineering 品质工程(部)QA Quality Assurance 品质保证处QC Quality Control 品质管制(课)PD Product Department 生产部LAB Laboratory 实验室IE Industrial Engineering 工业工程R&D Research & Design 设计开发部。
Sample 样件Trial Run试生产Production生产7.Turning OutsideDiameter车外圆Turning tool 车刀4Outside diameter 外径Rev 转速2500rad/min Φ14.03Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Inspection report (PIR A01-Close off / Rework隔离 / 返工Chamfer 倒角F进刀量=0.03mm/r 1.4±0.015Projector 投影仪(490127)3pcs/ Machine start up orChange tool 3只/开机和换刀3pcs/3H AQL1.0 C=01.Inspection report (PIR A01-002)2.SPC control1.检验报告(报告编号：A01-002)2.SPC控制Close off / Rework隔离 / 返工5Outside diameter 外径Φ12.6±0.03Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工1Outside diameter 外径Φ16.18 0/-0.04Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool 3只/开机和换刀3pcs/3H AQL1.0 C=01.Inspection report (PIR A01-002)2.SPC control1.检验报告(报告编号：A01-002)2.SPC控制Close off / Rework隔离 / 返工25Angle 角度45.6°±5°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工8.Cutting Groove 割槽Cutting tool 切断刀2Outside diameter 外径Rev 转速2500rad/minФ 14+0.05Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework /Sort隔离 / 返工/全检38Roughness 粗糙度F进刀量=0.03mm/r Ra1.6Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工11Width宽度 2.2 +0.2/0Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工8Length 长度11.8±0.2Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工41Angle 角度3°±1°Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工26Radius圆弧R0.1 +0.1(2X)Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工9.Cutting off 切断Cutting tool 切断刀17Length 长度Rev 转速2500rad/minF进刀量=0.03mm/r23.4±0.1Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工10.Drilling hole 钻孔Drilling tool 钻头22Inside diameter 外径Rev 转速2500rad/minΦ6+0.1Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工36Concentricity 同轴度Φ0.02Concentricity Gage同轴度仪(19753-A-10P)3pcs/ Machine start up orChange tool3pcs/3H AQL1.0 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工40Roughness 粗糙度F进刀量=0.03mm/r Ra6.3Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工14Length 长度9±0.25Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工33Angle 角度118°±3°Contracer轮廓仪(DD-0009)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工31Chamfer 倒角0.2 +0.2/0.1*45Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工11.Drilling hole 钻孔Drilling tool 钻头Hole diameter 孔径Rev 转速2500rad/minF进刀量=0.03mm/rΦ10Process technice size过程工艺尺寸Reset-up重新调整12.Boring Hole镗孔Boring tool 镗刀23Inside diameter 外径Rev 转速3000rad/minF进刀量=0.02mm/rΦ8.8±0.1Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工30Chamfer 倒角0.1*45°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工13highness 高度 2.5+0.2Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工12highness 高度 1.2±0.025Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工35parallel平行度0.02Dial indicator千分表3pcs/ Machine start up orChange tool 3pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工24Inside diameter 外径Φ13 +0.04Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up orChange tool3pcs/3H AQL1.0 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework / Scrap隔离 / 返工 / 报废Turning tool 车刀6Outside diameter 外径Rev 转速2500rad/minΦ14.6+0.1Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工39Roughness 粗糙度F进刀量=0.03mm/r Ra1.6Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工28Chamfer 倒角0.2±0.05*45°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工9highness 高度 3.8+0.1Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工29Chamfer 倒角0.2±0.1*45°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工7highness 高度19.6+0.05/0Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工13.Turning Outside Diameter车外圆。
（完整版）控制计划中英文版Sample 样件Trial Run试生产Production生产7.Turning OutsideDiameter车外圆Turning tool 车刀4Outside diameter 外径Rev 转速2500rad/min Φ14.03Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Inspection report (PIR A01-Close off / Rework隔离 / 返工Chamfer 倒角F进刀量=0.03mm/r 1.4±0.015Projector 投影仪(490127)3pcs/ Machine start up orChange tool 3只/开机和换刀3pcs/3H AQL1.0 C=01.Inspection report (PIR A01-002)2.SPC control1.检验报告(报告编号：A01-002)2.SPC控制Close off / Rework隔离 / 返工5Outside diameter 外径Φ12.6±0.03Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工1Outside diameter 外径Φ16.18 0/-0.04Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool 3只/开机和换刀3pcs/3H AQL1.0 C=01.Inspection report (PIR A01-002)2.SPC control1.检验报告(报告编号：A01-002)2.SPC控制Close off / Rework隔离 / 返工25Angle 角度45.6°±5°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工8.Cutting Groove 割槽Cutting tool 切断刀2Outside diameter 外径Rev 转速2500rad/minФ 14+0.05Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework /Sort隔离 / 返工/全检38Roughness 粗糙度F进刀量=0.03mm/r Ra1.6Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工11Width宽度 2.2 +0.2/0Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工8Length 长度11.8±0.2Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工41Angle 角度3°±1°Projector 投影仪(490127)3pcs/ Machine start up or1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工26Radius圆弧R0.1 +0.1(2X)Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工9.Cutting off 切断Cutting tool 切断刀17Length 长度Rev 转速2500rad/minF进刀量=0.03mm/r23.4±0.1Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工10.Drilling hole 钻孔Drilling tool 钻头22Inside diameter 外径Rev 转速2500rad/minΦ6+0.1Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up or1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工36Concentricity 同轴度Φ0.02Concentricity Gage同轴度仪(19753-A-10P)3pcs/ Machine start up orChange tool3pcs/3H AQL1.0 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工40Roughness 粗糙度F进刀量=0.03mm/r Ra6.3Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工14Length 长度9±0.25Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工33Angle 角度118°±3°Contracer轮廓仪(DD-0009)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工31Chamfer 倒角0.2 +0.2/0.1*45Projector 投影仪(490127)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工11.Drilling hole 钻孔Drilling tool 钻头Hole diameter 孔径Rev 转速2500rad/minF进刀量=0.03mm/rΦ10Process technice size过程工艺尺寸Reset-up重新调整12.Boring Hole镗孔Boring tool 镗刀23Inside diameter 外径Rev 转速3000rad/minF进刀量=0.02mm/rΦ8.8±0.1Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up orChange tool1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工30Chamfer 倒角0.1*45°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工13highness 高度 2.5+0.2Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工12highness 高度1.2±0.025Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工35parallel平行度0.02Dial indicator千分表3pcs/ Machine start up orChange tool 3pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工24Inside diameter 外径Φ13 +0.04Ping gauge 塞规(UGZ-***-0001/UGZ-***-0001)3pcs/ Machine start up orChange tool3pcs/3H AQL1.0 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework / Scrap隔离 / 返工 / 报废Turning tool 车刀6Outside diameter 外径Rev 转速2500rad/minΦ14.6+0.1Micrometer 千分尺(0~25mm)451384833pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工39Roughness 粗糙度F进刀量=0.03mm/r Ra1.6Roughness Tester 粗糙度仪DTS03A3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工28Chamfer 倒角0.2±0.05*45°Projector 投影仪(490127)3pcs/Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工9highness 高度3.8+0.1Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工29Chamfer 倒角0.2±0.1*45°Projector 投影仪(490127)3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工7highness 高度19.6+0.05/0Height Tester0~30mm(01194)高度规3pcs/ Machine start up orChange tool 1pcs/3H AQL1.5 C=0Inspection report (PIR A01-002)检验报告(报告编号：A01-002)Close off / Rework隔离 / 返工13.Turning Outside Diameter车外圆。
OPERATIONAL QUALIFICATION STERILE PROCESS VALIDATIONCLEANING VALIDATION (1/25)1. DOCUMENT HISTORYAdoption by PIC/S Committee 10 - 11 December 1998Entry into force of version PR 1/99-1 01 March 1999Entry into force of version PI 006-1 01 September 20012. INTRODUCTIONThe basic principles and application of qualification and validation are describedin Annex 15 to the PIC/S and EU Guide to GMP. This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows:Ø Validation Master PlanØ Installation and Operational QualificationØ Non-Sterile Process ValidationØ Cleaning ValidationThe four Recommendations comprising this document define general principles pertaining to each of the topics.2. 导言PIC/S和EU GMP指导原则的附录15中对确认(Qualification)和验证(Validation)的基本原则及应用进行了阐述。
