QA/QC英文手册4版

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工厂常用英语简写及职责(初版)

工厂常用英语简写及职责(初版)

- Internal Use Only -
工厂常用英语简写 CS工程师
英文全称:Customer satisfaction Engineer, 中文意思是客服工程师
7
主要职能
1、应对Customer Quality Issue 2、通过Customer requirement feedback 增大顾客满意度。 3、通过顾客满意度调查评价顾客的满意度并改善。 4、对顾客不良品进行Failure Analysis 5、顾客返品维修 及换货。 5、顾客返品维修及换货
- Internal Use Only -
工厂常用英语简写 QE
英文全称: Quality Engineer, 中文意思是质量工程师
10
主要职能
1.参与新产品的开发和试制,及产品品质计划的制定。 2.参与解决制程中出现的质量问题,并根据工程检验标准追踪 确认,实行标准化 3.组织对现有产品的品质评审,评诂产品品质与工程规格,检 验标准和客户要求的符合性。 4.督促生产过程和检验过程严格按规程操作。 5.负责与客户联络检测标准和测量方法及时对应客户抱怨等事宜 6.参与产品品质先期策划,实施并跟踪产品品质。 7.负责品质管理成本分析 8.参与公与5S检查工作。
FQC Final Quality Control (最终品质管制)
OQC (Outgoing Quality Control) (出货品质管制)
- Internal Use Only -
工厂常用英语简写 QA工程师
英文全称: Quality Assurance Engineer, 中文意思是品质保证工程师
6、接受顾客审核
7、组织召开定期品质会议(with Customer) 8、组织进行顾客量产品的ECN ★

品质管理英文缩写对照表QA-QE-QC-SQE-OQC-IQE-IPQE-FQE-QSE-IQC-DQC-CQC

品质管理英文缩写对照表QA-QE-QC-SQE-OQC-IQE-IPQE-FQE-QSE-IQC-DQC-CQC

Final Quality control
FQC
成品检验控制 对已完成的产品进行检验的质量控制
Quality system team
QST
品质体系小组 负责质量体系有效运行的团队
Input Process Quality Control IPQC 过程品质控制 负责生产过程的质量控制
Total Quality Control
QC
品质控制
检验产品,控制品质
Quality Engineer
QE
品质工程师
负责从样品到量产整个生产过程的产品质量控制
Certified Quality Engineer
CQE
注册质量工程师 质量专业技术人员职业资格证明
Certified Quality Manager Supplier Quality Engineer Outgoing Quality Control Incoming Quality Engineer In-Process Quality Engineer
CQM SQE OQC IQE IPQE
注册质量经理 供应商管理工程 师 成品出厂检验 原材料质量工程 师 过程质量工程师
质量经理职业资格证明 对来料供应商进行管理的工程师 负责产品出厂前的质量检验 负责来料的检验 负责对生产过程进行监督检查
Final Quality Engineer
FQE
最终品质工程师 产品发货前产品质量的最终确认
Quality System Engineer
QSE
质量体系工程师 负责质量保证体系的管理和有效运行
Quality Assurance Engineer vendor Quality Engineer Incoming Quality Control Joint Quality Engineer

QA/QC英文手册簿4版

QA/QC英文手册簿4版

Control No. : QS-CSE-M01QA/QC MANUALRev. 4Complied by: Li WeiWenChecked by: Ge Zhi HaiWei ZhaoHong Reviewed by: Lv ZhongYiApproved by:Zhou XueZhongEnforcement Date : Sept. 24, 2004Chiwan SembawangEngineering Co Ltd7.6 Corrective Action7.7 Preventive Action7.8 Release Control7.9 Inspection and Test Plan4 7.10 OHS Management8.0 List of QA/QC Produces9.0 List of Quality Records10.0 Issue RecordAttachment1: Typical Inspection Test Plantheworld-wide s expectations with regard4QA/QCQA/QC Department shall establish and maintain its inspection and test system, control the product quality and safety according to customer’s requirements and relevant standards to achieve the related quality & OHS objectives.4h)Responsible for the OHS activities related to QA/QCDepartment.3.3 QA/QC FunctionsThe QA/QC Department mainly carries out various functions as given below.a)Establishment & maintenance of Quality System and Manuals.b)Quality planning.c)Material inspection.d)In-process inspection.e)Dimensional controlf)Surveillance for welding, thorough visual inspection priorto corrosion protection, blasting/coating, galvanizing.44a)Performance of quality audit including major vendors andsubcontractors.b)Preparation of inspection and test procedures, Quality Planand NDT extent etc.c)Liaison with project QC coordinator.d)Responsible for the calibration of measuring and testingequipment.e)Control of internal, external NCRs, and complaints fromcustomer.f)Evaluation of work load for tenders.g)Review of NDT drawing.h)Document Filling systems and submission.4.6 Welding EngineerThe Welding Engineer is directly responsible for the control of welder qualifications and welding consumables. He reports to QA Section Head. The following will be his main tasks:a)Receive inspection of welding consumables together withprocurement personnel and preparing inspection report.b)Supervising and instructing the storage, baking andissuance of welding consumables.c)Organizing training and certifying of welder and weldingoperator.d)Evaluation the performance of welder and welding operator.4.7 Assistant QA EngineerThe assistant QA engineer reports to the QA Section Head and shall be responsible for following tasks :a )Prepa ration of summary sheet for material traceability andQC/NDT inspection reports.b )Typing Quality System Manuals, procedures, inspection formatsand project documents.c)Control of non-conformance items.d)Monitoring of the workmanship and inspection activities.e)Liaison with customer inspectors on quality matterconcerned.f)Reporting of non-conformance items to project QCcoordinator.g)Issue conformance release notice to products .shall not be issued to public, only CSE personnel shall have access to this document.5.7 All latest revision are indicated with a | mark at theright margin of the revised paragraph or sentence.6.1.8 The QA Engineer shall demand Department Managersresponsible for the activity being audited to carry out their quality activities as per Quality System established by Company.6.1.9 Department Managers being audited should ensure thatnecessary and appropriate corrective actions are taken to eliminate detected non-conformities and their causes within specified time.6.1.10 T he QA/QC Department shall be responsible for the follow-upactivities to the corrective actions, include the verification of the actions taken and the reporting of verification results.6.1.11 A ll audit findings should be documented and/or submitted toGM/DGMs for information and / or comments.6.1.12 A ll quality audit reports are treated as Company’sCONFIDENTIAL documents.6.1.13 T he internal audit results shall be submitted to qualitymanagement review meeting for review.6.2.2.2 Allthe requirements and provisions adopted by the company for its quality & OHS management system should be documented in the form of procedures or manuals.6.2.2.3Recor ds are a special type of document and shall be maintained to demonstrate achievement of the required quality & OHS and effective operation of the quality & OHS system and controlled according to the requirements in clause 6.3.6.2.3 Initiation, approval and issuance of Document6.2.3.1Quali ty & OHS Manual should provide an adequate description of the quality & OHS management system while serving as a permanent reference in the implementation and maintenance of the system.6.2.3.2Compa ny manual and department manuals shall be checked by QA/QC Manager and Safety Department Manager, reviewed by Deputy General Manager and approved by GM prior to issue.6.2.3.3 Thegeneral working instructions and project procedures shall be approved by respective Department Manager. If required, it shall be submitted to customer for approval.6.2.3.4 Thepertinent issue of appropriate documents shall be available at appropriate locations where operation essential to the effective functioning of the quality & OHS system are performed. The issue records shall be maintained by the relevant departments.Chiwan Sembawang Engineering Co. Ltd.4Equipment/Facility443)The PMT shall photocopy the approved final documentsaccording to the requirements of contract, and returnthe original document to QA/QC Department.4)Upon completion of the project, the QA/QC Departmentshall hand over the original of final documents to theArchives of Technical Department.6.2.9 Disposal of documents6.2.9.1 Priorto disposal of documents, the QA/QC Manager shall verifythat the retention period is expired.6.2.9.2 Documents exceeding retention period aredisposed off by shredding, incinerating or tearing manually. If any obsolete documents are retained for legal and/or knowledge-preservation purpose, they shall be suitably identified by stamp marking.6.2.10 External document controlThe documents from customers or suppliers such as standards, specifications, drawings, site instructions or site queries shall be registered in a master list with an appropriate review approval and identification and the issuance shall be controlled by relevant functional departments.46.3.7 The records shall be stored and maintained to prevent fromdamage, loss and deterioration.6.3.8 The project records shall be compiled into the finaldocuments and controlled as per clause 6.2.8.6.3.9 Retention times of records shall be established dependingon the requirements of contract, management and statutory.The records required by applicable industry standards shall be retain for not less than the time period specified by the industry standards or 5 years whichever is longer.Records required to provide evidence of conformity to requirements and of the effective operation of the quality & OHS management system shall be retained for a minimum of5 years. Records exceeding retention period may be disposedoff by shredding, incinerating or tearing manually, prior to disposal, the QA/QC Manager and Safety Manager shall verify that the retention period is expired.46.4.7 The users of all such items shall make sure that they areusing only the calibrated equipment, and ensure they are protected from damage and deterioration during handling, maintenance and storage and mis-adjustment during operation, and ensure the environmental conditions are suitable for inspections and measurements performed.6.4.8 All unserviceable equipment shall be rejected andsegregated and an entry shall be made in the register.6.4.9 QA/QC Department, QA Engineer in particular, shall checkthat only calibrated equipment are used during the process of fabrication.6.4.10 C alibration of instruments such as UT detector, MTdetectors, Laser Range Finder, Leveling instrument shall be done by qualified personnel designated by QA/QC Manager in accordance with relevant calibration procedure or standards.6.4.11 C alibration of instruments such as steel tape measure,pressure gauges and recorders shall be done by Shen Zhen Academy of Metrology & Quality Inspection (SZAMQI) or other authority party.4ng consumable storagea) Welding materials shall be stored in such a manner as toprevent intermingling with materials of different specifications, brands and lots.b) Welding electrodes, wire and flux shall be put up above theground 0.1 - 0.3 meter to facilitate the air circulation all round.6.5.3.3Weldi ng consumable issuancea) Welding consumable room storeman shall dry flux coatedwelding electrodes and flux to minimize moisture contents and keep them in the heated storage oven under the conditions specified by the welding Engineer and/or manufacturer’s recommendations before being issued.b) The records for drying or baking shall be maintained by theelectrodes-room storeman.c) The welding consumable shall be issued according to projectbased on the type of welding consumable specified by welding engineer.6.5.3.4Weldi ng consumable usea) Welding consumable shall be used strictly in compliancewith WPS and the manufacturer’s recommendations.b) Welding electrodes, low-hydrogen electrodes in particular,shall be stored in quivers during use. Welding flux and flux core welding wire shall be kept away from moisture.6.5.4 Welder and welding operator6.5.4.1 All of welders and welding operations shall bequalified to relevant welding codes before allow them to6.5.5.3 W here a tack weld is incorporated in a welded joint, theshape of the tack shall be suitable for incorporation inthe finished weld, and it shall be free from cracks andother deposition faults, tack welds which crack shall beremoved.6.5.5.4 W elding quality and welder performance shall be controlledas per the requirement of clause 6.7 of this manual.。

QA、QE、QC 的区别

QA、QE、QC  的区别

PQA: Product Quality Assurance, 产品质量保证SQA: Supplier Quality Assurance,供应商质量保证IQC: Incoming Quality Control,进料检验DQA: Design Quality Assurance,设计质量保证TQA: Total Quality Assurance,全面质量保证OQC: Outgoing Quality ControI出货检验FQC: Final Quality Control,最终质量控制QA: Quality Assurance,质量保证QC: Quality Control,品质管理QE: Quality Engineering 品质工程IPQC是in process QC,我们这里叫做产线巡检FQC是final QC,是最终检查,是属于出货抽检前的一项检查,SQC是statistics QC,是统计质量控制,一般指使用数据进行SPC控制OQC就不用说,是出货抽检。

关于QC和QA虽然在说法上不同,品质控制和品质保证,我觉得没有太大的区别,只是品质管理的职能而已,具体工作都分在其他几项中了。

控制的重点在于生产过程保证的重点应该在于产品出货的保证。

QC 是来料控制,也就是进货检验OQC 是出货检验也就是出厂检验QC 是质量检验QA 指质量测试IPQC 制程控制PE 指制程工程师IE 指文件工程师QA是质量保证,英文就是quality assurance,在CMMI中QA的主要工作是质量评审和产品评审,在ISO8402:1994中的定义是“为了提供足够的信任表明实体能够满足品质要求,而在品质管理体系中实施并根据需要进行证实的全部有计划和有系统的活动”。

有些推行ISO9000的组织会设置这样的部门或岗位,负责ISO9000标准所要求的有关品质保证的职能,担任这类工作的人员就叫做QA 人员;QE是品质工程的意思,英文就是quality engineer,主要从事品质工程的文件制定,QE是建立、分析、完善品质控制程序的人,不会去查每一单货品;QC 是品质管理的意思,英文就是quality controller,主要按照QE指定的品质文件进行品质控制,是质量管理的一部分,致力于满足质量要求,qc是对人事、对物,直接致力于满足质量要求。

质量手册翻译中英文对照

质量手册翻译中英文对照

质量手册翻译中英文术语表3.1.1质量quality3.1.2要求requirement3.1.3等级grade3.1.4顾客满意customer satisfaction3.1.5能力capability3.2.1体系(系统)system3.2.2管理体系management system3.2.3质量管理体系quality management system 3.2.4质量方针quality policy3.2.5质量目标quality objective3.2.6管理management3.2.7最高管理者top management3.2.8质量管理quality management3.2.9质量策划quality planning3.2.10质量控制quality control3.2.11质量保证quality assurance3.2.12质量改进quality improvement3.2.13持续改进continual improvement3.2.14有效性effectiveness3.2.15效率efficiency3.3.1组织organization3.3.2组织结构organizational structure3.3.3基础设施infrastructure3.3.4工作环境'77ork environment 3.3.5顾客customer3.3.6供方supplier3.3.7相关方interested party3.4.1过程process3.4.2产品product3.4.3项目project3.4.4设计和开发design and development 3.4.5程序procedure3.5.1特性characteristic3.5.2质量特性quality characteristic 3.5.3可信性dependability3.5.4可追溯性traceability3.6.1合格(符合)conformity3.6.2不合格(不符合)nonconformity 3.6.3缺陷defect3.6.4预防措施preventive action3.6.5纠正措施corrective action3.6.6纠正correction3.6.7返工rework3.6.8降级regrade3.6.9返修repair3.6.10报废scrap3.6.11让步concession3.6.12偏离许可deviation permit3.6.13放行release3.7.1信息information3.7.2文件document3.7.3规范specification3.7.4质量手册quality manual3.7.5质量计划quality plan3.7.6记录record3.8.1客观证据objective evidence3.8.3试验test3.8.4验证verification3.8.5确认validation3.8.6鉴定过程qualification process3.8.7评审review3.9.1审核audit3.9.2审核方案audit programme3.9.3审核准则audit criteria3.9.4审核证据audit evidence3.9.5审核发现audit findings3.9.6审核结论audit conclusion3.9.7审核委托方audit client3.9.8受审核方auditee3.9.9审核员auditor3.9.10审核组audit team3.9.11技术专家technical expert3.9.12能力competence3.10.1测量控制体系measurement control system 3.10.2测量过程measurement process3.10.3计量确认metrological confirmation3.10.4测量设备measuring equipment3.10.5计量特性metrological characteristic 3.10.6计量职能metrological function Aaudit3.9.1审计audit client 3.9.7客户审计audit conclusion3.9.6审计结论audit criteria3.9.3审计标准audit evidence3.9.4审计证据audit findings3.9.5audit programme3.9.2审计大纲audit team3.9.10审计团队auditee3.9.8auditor3.9.9Ccapability3.1.5characteristic3.5.1concession3.6.11conformity3.6.1continual improvement3.2.13 correction3.6.6corrective action3.6.5customer 3.3.5customer satisfaction3.1.4 competence3.9.12Ddefect3.6.3dependability 3.5.3design and development3.4.4deviation permit3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency3.2.15Ggrade3.1.3Iinformation3.7.1infrastructure3.3.3inspection3.8.2interested party3.3.7Mmanagement3.2.6management system3.2.2 measurement control system3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic3.10.5 metrological confirmation3.10.3 metrological function3.10.6Nnonconformity 3.6.2Oobjective evidence3.8.1客观证据organization3.3.1organizational structure3.3.2Ppreventive action3.6.4 procedure3.4.5process3.4.1product3.4.2project3.4.3Qqualification process3.8.6 quality3.1.1quality assurance3.2.11quality characteristic3.5.2 quality control3.2.10quality improvement 3.2.12 quality management3.2.8quality management system3.2.3 quality manual3.7.4quality objective3.2.5quality plan 3.7.5quality planning3.2.9质量计划quality policy3.2.4Rrecord3.7.6记录regrade3.6.8release3.6.13放行repair3.6.9requirement3.1.2review3.8.7rework3.6.7返工Sscrap3.6.10specification 3.7.3supplier 3.3.6供应商system3.2.1系统Ttechnical expert<audit>3.9.11技术出口test3.8.3测试top management3.2.7高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment3.3.4工作环境质量管理体系基础和术语Quality management syst ems--Fundamentals and vocabulary质量管理和质量保证标准第2部分:GB/T19001、GB /T19002和GB/T19003实施通用指南Quality mana gement and quality assurance standards--Part 2:Generic guidelines for the application of GB /T19001、GB/T19002and GB/T19003质量管理和质量保证标准第3部分:GB/T19001在计算机软件开发、供应、安装和维护中的使用指南Qu ality management and quality assurance standard s--Part3:Guidelines for the application of GB/T19001to the development,supply,installa tion and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南Quality management and quality assurance s tandards--Part4:Guide to dependability prog ramme management质量管理体系要求Quality management systems--Requirements质量管理体系业绩改进指南Quality management sy stems--Guidelines for performance improvement s质量管理和质量体系要素第2部分:服务指南Quali ty management and quality system elements--Pa rt2:Guidelines for services质量管理和质量体系要素第3部分:流程性材料指南Quality management and quality system elements --Guidelines for processed materials质量管理和质量体系要素第4部分:质量改进指南Q uality management and quality system elements--Guidelines for quality improvement质量管理质量计划指南Quality management--Gui delines for quality plans质量管理项目管理质量指南Quality management--Guidelines to quality in project management 质量管理技术状态管理指南Quality management--Guidelines for configuration management质量体系审核指南审核Guidelines for auditing q uality systems--Part1:Auditing质量体系审核指南质量体系审核员的评定准则Guide lines for auditing quality systems--Part2:Q ualification criteria for quality systems audit ors质量体系审核指南审核工作管理Guidelines for au diting quality systems--Part3:Management of audit programmes测量设备的质量保证要求第一部分:测量设备的计量确认体系Quality assurance requirements for mea suring equipment Part1:Metrological confirmat ion system for measuring equipment测量设备的质量保证第2部分:测量过程控制指南Q uality assurance for measuring equipment--Par t2:Guidelines for control of measurement proc esses质量手册编制指南Guidelines for developing qual ity manuals质量经济性管理指南Guidelines for managing the economics of quality质量管理培训指南Quality management--Guideli nes for trainingEnglish Chinesereceipt(入厂)接受,验收,进货handling搬运packaging包装storage保存protection保护comparison比较identification标识replacement of identification mark标识标志更换maintenance of identification标识的保持records of identification control标识控制记录tender标书normative document标准文件supplemental补充nonconforming product不合格品control of nonconforming product不合格品控制control procedure of nonconforming products不合格品控制程序tendency of nonconformance不合格倾向purchasing采购verification of purchased product采购的产品验证purchasing process采购过程purchasing control procedure采购控制程序purchasing information采购信息reference standard参照标准reference instructions参照细则stockhouse仓库measurement,analysis and improvement测量,分析和改进measurement result测量结果control procedure of monitoring and measuring d evices测量设备控制程序planning策划preservation of product产品保护control procedure for maintenance,replacement and records of product identification产品标识的保持,更换及记录控制程序procedure for product identification and tracea bility产品标识和可追溯性程序conformity of product产品的符合性monitoring and measurement of product产品的监督和测量product plan产品方案control procedure for product preservation产品防护控制程序method of product release产品放行方法conformity of product,product conformity产品符合性product realization产品实现planning of product realization产品实现策划product characteristics产品特性input to product requirements产品要求的输入product status产品状态final acceptance of product产品最后验收procedure程序program documents程序文件continual improvement持续改进procedure for continual improvement of quality management system持续改进质量体系程序adequacy充分性storage location存放地点agency personnel代理人员submission of tenders递交标书adjustment调整,调节statutory and regulatory requirements法律法规要求rework,vt返工repair,vt返修subcontractor分承包方annex附录improvement改进improvement actions改进措施on-the-job training岗位技能培训responsibility of individual department and pos t各部门,各岗位职责change identification更改标记change order number更改单编号process sheets工艺单process specification工艺规程procedure(process card)工艺规程(工艺卡) process characteristics工艺特性Job Description Format工种描述单work environment工作环境impartiality公正性functional requirements功能要求supplier供方supplier evaluation procedure供方评价程序supplier provided special processes供方提供的特殊过程verification at supplier's premises供方现场验证supply chain供应链criteria for supplier selection,evaluation and re-evaluation供应商选择、评估和再评估准则communication沟通customer顾客customer property顾客财产control procedure for customer property顾客财产控制程序customer feedback顾客反馈Customer Service Contact Form顾客服务联系表customer communications顾客沟通customer satisfaction顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint顾客投诉identification of customer requirements顾客要求的识别management review管理评审records from management review管理评审记录management review control procedure管理评审控制程序management representative管理者代表management responsibility管理职责specified limits of acceptability规定的可接受界限specified use规定的用途process过程complexity of processes过程的复杂性monitoring and measurement of processes过程的监视和测量operation of process过程的运行status of processes过程的状态process approach过程方法process controls过程控制process control documents过程控制文件process performance过程业绩appropriateness合适性changes to contractor合同的更改contract review control procedure合同评审控制程序internet sales互联网销售environmental conditions环境条件monogram pragram requirements会标纲要要求type of activities活动类型infrastructure基础建设infrastructure基础设施fundamentals and vocabulary基础与词汇control of records记录控制technical specificaion技术规范process trace sheet加工跟踪单monitoring and measurement监视和测量monitoring and measuring device监视和测量装置control of monitoring and measuring devices监视和测量装置控制check method检查方法frequency of checks检查频次calibration status检定状态inspection and test control procedure检验和试验控制程序identification procedure for inspection and tes t status检验和试验状态标识程序inspection witness point检验见证点inspection hold point检验停止点buildings建筑物delivery交付post-delivery activities交付后的活动delivery activities交付活动interface接口acceptance of contract or orders接受合同或定单type of medium介质类型experience经验correction action纠正措施Corrective action response time纠正措施答复时间,纠正措施响应时间management procedure for corrective actions纠正措施管理程序corrective action response times纠正措施响应时间development activity开发活动traceability mark可追溯性标志objectivity客观性Customer Service Log客户服务记录簿control feature控制特性,控制细节control features控制细则periodic assessment of stock库存定期评估justification理由routine例程,惯例,常规质量职能分配表论证范围internal communication内部沟通internal audit内部审核internal audit procedure内部审核程序internally controlled standard内控标准internal audit内审results of internal and external audits内外部审核结果competence能力training培训training needs培训需要evaluate评价records of the results of the review评审结果的记录review output评审输出review input评审输入Purchase Requisition请购单authority权限validation确认concession让步human resources人力资源job training of personnel人员岗位培训qualification of personnel人员资格equipment control procedure设备控制程序device type设备类型order of design changes设计更改通知单design and development control procedure设计和开发控制程序design and development设计开发design and development planning设计开发策划control of design and development changes设计开发更改控制design and development review设计开发评审design and development validation设计开发确认design and development outputs设计开发输出design and development inputs设计开发输入design and development verification设计开发验证design validation设计确认design documentation设计文件编制design acceptance criteria设计验收准则design verification设计验证audit program审核大纲conduct of audits审核行为audit criteria审核准则production process control生产过程控制production process control procedure生产过程控制程序production and service provision生产和服务提供control of production and service provision生产和服务提供的控制validation of processes for production and serv ice provision生产和服务提供过程的确认production order生产令identification and traceability识别和可追溯性identification and traceability maintenance and replacement识别和可追溯性维护与替换invalidate使失效market survey市场调研suitability适宜性scope适用范围controlled condition受控状态terms and definitions术语与定义analysis of data数据分析sequence顺序transfer of ownership所有权转移system document体系文件statistical technique统计方法outsource(vt)a process外包过程external source外部来源documents of external origin外来文件outsource,vt外协unique identification唯一的标识maintenance维护Document Change Control文件更改控制Request For Document Change(RDC)文件更改需求单control of documents文件控制documentation requirements文件要求enquiry问询,询价field nonconformity analysis现场不符合分析relevance相关性interaction相互作用detail design详细设计,详图设计,零件设计,施工设计sales department销售部sales contract销售合同checklist校验表,一览表,检查一览表calibration校准submission of action plans行动计划的递交documented procedures形成文件的程序documented statement形成文件的声明performance requirements性能要求licensee responsibilities许可证持有者责任acceptance criteria验收准则verification arrangement验证安排verification results验证结果customer focus以客户为关注点,以客户为焦点awareness意识introduction引言,概述,介绍normative references引用标准application应用visit to user用户访问review of requirements related to the product 有关产品的要求评审competent有能力的effectiveness有效性determination of requirements related to the pr oduct与产品有关的要求的确定customer-related processes与顾客有关的过程preventive action预防措施management procedure for preventive actions预防措施管理程序planned results预期的结果intended use预期的用途procedure for competence,knowledge and trainin g of personnel员工能力,知识和培训程序personnel training procedure员工培训程序supporting services支持性服务functions职能部门responsibility职责assignment of responsibility职责分工workmanship制造工艺manufacturing acceptance criteria制造验收准则quality policy质量方针quality programs质量纲领quality management system质量管理体系quality management system planning质量管理体系策划performance of the quality management system质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form质量问题处理单quality requirements质量要求allocation table of quality responsibilities质量职能分配表availability of resources资源的可获得性resource management资源管理allocation of resources资源配置provision of resources资源提供general requirements总要求,一般要求constituent part组成部件organization组织continual improvement of the organization组织的持续改进size of organization组织的规模Organizational Diagram组织机构图final acceptance最终验收work instructions作业指导书。

英文版质量手册

英文版质量手册
8.2Monitor and Measure……………………………………….…………….55
8.3Control of Unqualified Products………………………………………….59
8.4 Data Analysis…………………………………………………………….60
8.5Improvement……………………………………………….…………….61
7.3Design and Development………………………………...……………..46
0ห้องสมุดไป่ตู้2Table of Contents
Page
2/2
7.4Purchase………………………………………………….………………47
7.5Supply for Production and Service……………………………………...49
5.5Duties&Extent of Authority and Communication…….………….…...31
5.6Management Appraisal and Examination……………....……………...35
6.0Ressources Management……………………………………………….37
2.0Standards Cited…………………………………..……...….….………13
3.0Technical Terms and Definitions…………………..…….………….…15
4.0The “Quality Management System”………………………...….……....17
Clause revised
Date of revision

品质管理英文缩写对照表QA-QE-QC-SQE-OQC-IQE-IPQE-FQE-QSE-IQC-DQC-CQC

品质管理英文缩写对照表QA-QE-QC-SQE-OQC-IQE-IPQE-FQE-QSE-IQC-DQC-CQC
Design Quality Assurance
In-process Quality control Final Quality control Quality system team Input Process Quality Control
英文简 称
中文全称
QA
品质保证
QC
品质控制
QE
品质工程师
序号英文全称英文简称中文全称1quallityassuranceqa品质保证2quallitycontrolqc品质控制3qualityengineerqe品质工程师4certifiedqualityengineercqe注册质量工程师5certifiedqualitymanagercqm注册质量经理6supplierqualityengineersqe供应商管理工程师7outgoingquallitycontroloqc成品出厂检验8incomingqualityengineeriqe原材料质量工程师9inprocessqualityengineeripqe过程质量工程师10finalqualityengineerfqe最终品质工程师11qualitysystemengineerqse质量体系工程师12quallityassuranceengineerqae品质保证工程师13vendorqualityengineervqe厂商品质工程师14incomingqualitycontroliqc进料检验质量控制15jointqualityengineerjqe客服工程师16designquallityassurancedqc设计品保工程师17inprocessqualitycontrolipqc过程质量控制18finalqualitycontrolfqc成品检验控制19qualitysystemteamqst品质体系小组20inputprocessqualitycontrolipqc过程品质控制21totalqualitycontroltqc全面质量管理22qualityreliabilityengineerqre质量可靠性工程师23qualitymanagementsystemqms质量管理体系24environmentalmanagementsystemems环境管理体系25chinaqualitycertificationcentrcqc中国质量认证中心质量管理中涉及的名词英文缩写职责主要职责就是质量保证工作检验产品控制品质负责从样品到量产整个生产过程的产品质量控制质量专业技术人员职业资格证明质量经理职业资格证明对来料供应商进行管理的工程师负责产品出厂前的质量检验负责来料的检验负责对生产过程进行监督检查产品发货前产品质量的最终确认负责质量保证体系的管理和有效运行保证公司的产品质量符合用户要求主要是负责制程品质维

QA成品检查作业指导书-中英文版

QA成品检查作业指导书-中英文版

1. PurposeAccording to Product Specification, this Sop defined the QA inspection requirements for finished goods.目的依據產品規格,這份指引定義了QA關於咖啡機檢查的要求。

2. ScopeApply to finished goods inspection for finished goods.範圍適用于QA咖啡機的成品檢查。

3. ProcedureAccording to Product Specification & Customers’ data QA will do detailed inspection for finished goods.程序依據產品規格及客資料對咖啡機進行詳細的檢查:3.1 Outside box inspection1) N.W/G.W2) Printed on outside box-Machine type and color3) C/No.4) Sealing tape外箱檢查1)檢查卡通箱重量2)檢查外箱機型跟顏色3)卡通箱箱號4)封箱膠紙3.2 Giftbox inspection1) Label on giftbox2) Operation manual3) Poly bag with note languages, and safely holes彩盒檢查1)貼紙2)說明書3)膠袋警告標示3.3 Unit visual inspection1) The machine is clean, no fingerprints ets.2) No damage, colorful, scratching etc.機身外觀檢查1)表面是否有臟污2)外觀是否有損壞,雜色,刮傷等3.4 Check bottom of machine1) Bar code & Rating labelIf this procedure is printed, it is an UNCONTROLLED copy.。

质量手册英文版

质量手册英文版

CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALContents Page 1 of 1 pagesFourth edition Revision status: 0 ContentsClause No. Description0Contents1Foreword2The management of quality assurance manual3Terms4Quality assurance system requirements4.1Management responsibility4.2Quality system4.3Contract review4.4Design control4.5Document and data control4.6Purchasing4.7Control of Employer-supplied product4.8Product identification and traceability4.9Process control4.10Inspection and testing4.11Control of inspection, measuring and test equipment4.12Inspection and test status4.13Control of nonconforming product4.14Corrective and preventive action4.15Handling, storage, packaging, preservation and delivery 4.16Control of quality records4.17Internal quality audits4.18Training4.19Servicing4.20Statistical techniquesChart Organization structure of quality assurance system of the Company Attachment No.1: Quality system requirements and quality responsibility Attachment No.2: List of documented proceduresQUALITY ASSURANCE MANUAL Foreword Page 1 of 2 pagesFourth edition Revision status: 01Foreword1.1Brief Introduction of the CompanyCSCEC Construction Co. LTD is a construction enterprise invested byhis holding company, China State Construction EngineeringCorporation (CSCEC) offering mainly services of general projectmanagement in engineering construction projects contracting business.The company was established and registered in China in 1993 and itwas ratified as a state-level construction contracting enterprise by theMinistry of Construction of PRC.The project of Beijing Lufthansa Center (a national project) contractedby the predecessor of the company was executed and managedseverely in accordance with FIDIC contract conditions and wascompleted on time with good quality. The project was awarded “LuBan Prize ”, the designation of good qualit y project by the Ministry ofConstruction of PRC, and the National Prize for Good Quality Project.The company have enjoyed the high social prestige and obtained theeconomic effect. Since the establishment of the Company, theCompany has contracted or completed in succession the major projects,such as the New German Embassy in Beijing, the NORINCO Building,Beijing Sunflower Tower, Bayer Pharmaceutical Plant and Head OfficeBuilding of Bank of China, etc.The Company strictly implements the contract, and puts quality first inits contracted projects. The Company always satisfies the Employersby offering the quality services that conform to the internationalquality standards.The Company, soon after its establishment, formulated the qualityassurance system in accordance with the requirement of GB/T 19000--- ISO 9000 and was given formal recognition and certificate ofquality system certification for ISO 9002.The Company possesses a group of excellent engineering technicalpersonnel with the knowledge of the international contract conditionsand the sound contract management, and with rich practicalQUALITY ASSURANCE MANUAL Foreword Page 1 of 2 pagesFourth edition Revision status: 0experiences in this field both in China and abroad. The Company alsoposses abundant capital and stable network for purchasing thematerials, machinery and equipment for construction projects both inChina and abroad. The Company may undertake all kinds of Works ofcivil Engineering construction, including industrial and civil buildingprojects.The Company may offer consultant service for project constructionand project consultant, and project design, and the service for importand export trade of building materials, etc.1.2Introduction of the Quality Assurance ManualThis Quality Assurance Manual has described and defined the qualitysystem, the quantity policy and the quality objectives of the Company.The manual shall be a guide document concerning the quality systemof the Company.The manual shall be applied to all kinds of Works of Civil EngineeringConstruction contracted by the Company, including industrial and civilbuilding projects.The manual shall be a top secrete document controlled by theCompany.The manual shall be prepared by the Quality Assurance Division andreviewed by the Management Representative. The manual shall comeinto force from the date of approval by the Managing Director of theCompany.CSCEC CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALThe Control ofQuality AssuranceManualCSCEC/DQA/PRO/98/001Page 1 of 3 pagesFourth edition Revision status: 02.The Control and Management of Quality Assurance Manual2.1Approval2.1.1Before the manual is officially issued, the Quality Assurance ManualShall be reviewed by Managing Director, Management Representative,Managers of Project Division and Division managers in order toguarantee its clear and accurate meanings, its suitability and itsreasonable structure.2.1.2The manual shall come into force beginning from the date of approvalby the Managing Director of the Company and shall be carried intoeffect beginning from the approved date of implementation.2.2Issue2.2.1The original and the copies of the Manual: The approval page of theoriginal of the Quality Assurance Manual shall be put by the ManagingDirector’s own signature, and the rest page s of the originalManual shall be signed by those responsible for preparing,reviewing and approving the document.The copies of the Manual shall mean the copies of the original of theQuality Assurance Manual. The original of the Quality AssuranceManual shall remain in the sole custody of the Quality AssuranceDivision and the copies of the Manual shall be issued to all the holdersof the Manual.2.2.2The holders of the manual shall include the Company’s leaders,Management Representative, managers of Project Divisions, divisionmanagers, project managers and other approved holders. The details ofthe manual holders will be prepared by the Quality Assurance Divisionand will be submitted to the Management Representative for approval.2.2.3The Quality Assurance Division shall in unified way, distribute theManual. The seal of controlled documents shall be attached to theQuality Assurance Manual distributed by the Quality AssuranceDivision. The Manual shall be numbered for the control purpose. TheQuality Assurance Division shall fill out a register of controlleddocuments.CSCEC CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALThe Control ofQuality AssuranceManualCSCEC/DQA/PRO/98/001Page 2 of 3 pagesFourth edition Revision status: 02.2.4When the above mentioned holders of the Manual leave their relevantoffices, they shall immediately return the Quality Assurance Manualwhich they hold, and the Quality Assurance Division shall write offtheir registrations.2.3Amendment2.3.1 Any amendments to the Manual shall be made by the QualityAssurance Division and shall be approved by the ManagingDirector of the Company. Any amendments without an officialamendment notice shall be deemed to be null and void.2.3.2The Quality Assurance Division shall be responsible for sending theamendment notice to the holders of the Manual and shall require all theholders to be responsible for making amendments. The QualityAssurance Division shall keep the records of any amendments on theAmendment Sheets of Quality Assurance Manual. The amendmentsheets shall, together with the contents of amendments, be sent to allthe holders of the Manual.2.4Use and Custody2.4.1When the holders of the Manual receive the amendment sheets of thequality manual, the holders shall sequentially attach the amendmentsheets to the front of the Manual in order to find out the case ofamendments to the Manual.2.4.2The holders of the Manual shall be responsible for implementation ofthe provisions of the Quality Assurance Manual.2.4.3The holders of the Manual shall be responsible for the custody of theManual which they hold, and shall prevent the Manual from anydamage, loss and alterations to the Manual. When the Manual is founddamaged and lost, the holders of the Manual shall immediately reportthe matter in question to the Quality Assurance Division.2.5uncontrolled Copies2.5.1 For the purposes of Employer and quality audit body off-site usageand other distribution of the Manual where change control is notCSCEC CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALThe Control ofQuality AssuranceManualCSCEC/DQA/PRO/98/001Page 3 of 3 pagesFourth edition Revision status: 0intended, all such distributed manuals shall be clearly identified asuncontrolled copies.2.5.2 When any Divisions and Projects need uncontrolled copies of theManual, they shall, in written form, apply to the ManagementRepresentative for approval. The applicant shall, in his application,state the reasons for uncontrolled copies of the Manual and its holder.2.5.3 The Quality Assurance Division shall be responsible for distribution ofuncontrolled copies of the Manual. The seal of controlled copies shallnot be attached to the cover of the uncontrolled Manual. The QualityAssurance Division shall fill out a register of distributing uncontrolledcopies.CSCECCONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUAL DefinitionsCSCEC/DQA/QAM/98/ 001Page 1 of 2 pagesFourth edition Revision status: 03Definitions3.1General TermsFor the purposes of this Quality Assurance Manual, The definitionsgiven in ISO8402 apply.3.2Definitions related to this ManualTerms DefinitionsEmployer m eans the legal person or natural person whoowns a construction project and decides toaward the project to the Company by the formof signing and concluding a Contract or anAgreement.The Employer in the Manual alsorefers to his holding company. (It is calledcustomer in International Standard ISO 9002).Company means CSCEC Construction Co. LTD.Company Leaders m eans Managing Director, Deputy GeneralManager, Chief Economist, Chief Accountant,Chief Engineer, and ManagementRepresentative of the Company.Management Representative means the person from the Company’smanagement appointed by the ManagingDirector. He shall be responsible for thequality system of the Company.Manager of Project Division M eans the person appointed by the ManagingDirector to act as Manager of Project Divisionwho shall be responsible for the managementof all the projects in the project division.Project m eans the management organization whoShall execute and manage the constructionproject (works) contracted by the Company.CSCECCONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUAL DefinitionsCSCEC/DQA/QAM/98/ 001Page 2 of 2 pagesFourth edition Revision status: 0Subcontractor means the legal person or the natural person towhom some parts of the Works issubcontracted by singing and concluded theSubcontract between the Company and theSubcontractor. Such Subcontractor also meansone of the Subcontractors defined in theStandards.Supplier means the legal person or the natural personwho provides products and materials to theCompany by signing and concluding aContract for supplying goods. Such Supplieralso means one of the Subcontractors definedin the Standards.Employer’s Contract means the Contract for the constructionproject (works) signed and concluded by andbetween the Employer and the Company, ormeans all the requirements (hereinafter alsocalled the Contract) agreed and communicatedby any means between the Employer and thecompany.Subcontract means the Subcontract for part of thecontraction works signed and concluded byand between the Company and theSubcontractor.Products means all raw materials, semi-finishedproducts, structural components andmachinery and equipment for incorporation inthe permanent works.Division / Project means the short form for all the Divisionand/or the Project.CONSTRUCTION CO., LTD.QUALITY ASSURANCE MANUAL Responsibility Page 1 of 10 pagesFourth edition Revision status: 04Quality Assurance System Requirements4.1Management Responsibility4.1.1Quality Policy4.1.1.1The quality policy of the Company shall be as follows:We believe in the principle of winning our Employers’ trust withexcellence in the quality of our products and services.4.1.1.2The policy reflects what we require of our entire staff: devotion andtrustworthiness. Translated into action, this means continuous drive toraise the efficiency of management and update our expertise withconcerted effort. Such improvement is seen in the quality of ourproducts and services and in our unfailing effort to meet all therequirements of our Employers.4.1.1.3The quality objectives of the Company shall be as follows:Strict procedures for the best possible management, high levelexpertise, first class quality guaranteed for all the contracted Works,projects meeting all requirements for their immediately acceptance byEmployers upon completion (immediately acceptance ratio up to100%), good quality ratio up to 80 percent per unit of works, workseligible for “Excellence in Quality” and “Luban Prize” awards of theMunicipality and the Ministry, guaranteed satisfaction andzero-complaints from Employers.4.1.1.4The Personnel Division shall be responsible for training courses of thequality policy and the quality objectives. The Personnel Division shallensure that all the Company staff shall be familiar with and master thequality policy and the quality objectives.4.1.1.5In order to implement the quality policy and the quality objectives inall the projects, each construction project shall work out the qualityplanning prior to the commencement of the works, and shall define thequality objectives and the management measures of the project.4.1.2Organization4.1.2.1Responsibility and AuthorityCONSTRUCTION CO., LTD.QUALITY ASSURANCE MANUAL Responsibility Page 2 of 10 pagesFourth edition Revision status: 0A.Establishment of Organization StructureThe Company Leaders are responsible for establishing and adjustingthe Company Organization structures, defining the responsibility,authority and the Company Leaders shall define interrelation of thepersonnel who engage in the work affecting the quality. Theorganizational structures related to the Company’s quality assurancesystem and functions related to the quality assurance system areannexed to this Manual (See Attachment No.1)B.Description of Quality Responsibilitya.The Managing Director of the Company shall--- control and manage the overall work concerning the quality system of the Company;--- be responsible for working out the quality policy and the quality objectives of the Company, and approve the Quality AssuranceManual.--- establish and adjust the organization of the Company and define the responsibility and authority of the divisions of the Company.--- be responsible for the management review of the quality system and appoint the Management Representative.b.Deputy General Manager of the Company shall--- assist the Managing Director in the management of the quality system;--- participate in working out an d implementing the Company’s quality policy and the quality objectives, and assist the ManagingDirector in the management work;--- be authorized by the Managing Director to be responsible for the function divisions of the Company;--- Control and manage the plan and objectives of the work that he shall be i n charge of , and supervise the implementation of the planand the objectives of the work;--- be responsible for the quality assurance and the quality improvement that he shall be in charge of.CONSTRUCTION CO., LTD.QUALITY ASSURANCE MANUAL Responsibility Page 3 of 10 pagesFourth edition Revision status: 0c. Management Representative shall--- ensure that the Co mpany’s quality system shall be established, implemented and maintained;--- participate in working out and implementing the quality policy and the quality objectives of the Company;--- be responsible for approving the documented procedures and the Project Quality Plan;--- be responsible for supervising the internal quality system audits of the Company;--- assist the Managing Director in management reviews;--- report the results of the operations of the quality system of the Company to the Managing Director;--- arranging the quality system audits of Subcontractor;--- on behalf of the Company, deal with and coordinate all the work concerning quality management and the quality assurance betweenthe Contractor and the Employer, and be responsible for the workrelating to the quality system certification.d. Three Chiefs shall--- participate in working out and implementing the quality policy and the quality objectives of the Company, and assist the ManagingDirector in t he Company’s work;--- be authorized by the Managing Director to be responsible for the divisions of the Company;--- control and manage the plan and objectives of the work that he shall be in charge of, and implement the plan and the objectives ofthe work in question;--- be responsible for the quality assurance and quality improvement of the work he shall be in charge of.CONSTRUCTION CO., LTD.QUALITY ASSURANCE MANUAL Responsibility Page 4 of 10 pagesFourth edition Revision status: 0e.Manager of Project Division shall--- Participate in working out and implementing the quality policy and the quality objectives of the Company;--- be authorized by the Managing Director to be responsible for the projects in the project division, and shall, on behalf of theCompany, accept the Works and guide the execution of the Works;--- carry out the following work: Contract review, tendering, signing the Contract, the Project Quality Planning, the completion of theWorks and remedying defects in the Works;--- be responsible for the quality assurance and the quality improvement of the projects in the project division that he shall bein charge of.--- be responsible for approving the Project Quality Plan prepared by the Project.f.Quality Assurance Division shall--- assist the Management Representative in promoting and implementing the ISO9000 family;--- assist the Manager Director in preparing the quality policy and the quality objectives of the Company.--- be responsible for the work relating to preparation, issue, amendment and version change of the Quality Assurance Manualand documented procedures;--- assist the Management Representative in carrying out the internal quality system audits of the Company, and promoting andimplementing the Internal Quality Audits Procedures;--- be responsible for reviewing the “Project Quality Plan”. and responsible for reviewing the Project Quality planning;CONSTRUCTION CO., LTD.QUALITY ASSURANCE MANUAL Responsibility Page 5 of 10 pagesFourth edition Revision status: 0--- implement the laws and regulations of the safety and prepare the detailed rules and regulations for implementation, and beresponsible for reporting, analyzing and dealing with the incidentsand educating the relevant personnel;--- promote and implement the Process Control Procedures, theControl of Nonconforming Product Procedures and theCorrective and Preventive Action Procedures;--- be responsible for preparing the training plan for all personnel performing activities affecting the quality system and the personnelperforming specific assigned tasks, and implement the training plantogether with the Personnel Division;--- pay a return visit to the completed works and deal with the claims from the Employer, and shall supervise and implement theServicing Procedures;--- be responsible for supervising the application of the statistical techniques, and for implementing the Statistical TechniquesProcedures.g.Planning Division shall--- assist the Managing Director in adjusting the Company organization structure, and defining the responsibility and authorityof all personnel of the Company.h.Administration Division shall--- be responsible for the management and control of the Company’s documents, and shall supervise and implement the Document andData Control Procedures ;--- be responsible for the management and control of the Company’s files, and shall supervise and implement the Control of QualityRecords Procedures.i.Personnel Division shallQUALITY ASSURANCEResponsibility Fourth edition Revision status: 0 MANUAL--- prepare the training plan for all personnel of the Company, and shall supervise and implement the Training Procedures;--- provide all personnel relating to the quality management and other personnel of the management, and shall assess their assigned tasks;--- be responsible for training all personnel performing specific assigned tasks and shall ensure that all staff members are theholders of the professional qualification certificate.j.Estimation Division shall--- prepare the tender documents, guide and participate in the Contract evaluation, and shall promote and implement the Contract ReviewProcedures;--- be responsible for evaluating the Subcontractor, assist the Project Divisions in selecting the Subcontractor, and shall supervise andimplement the Subcontractor Select Procedures;--- prepare the training plan for the personnel relating to the tendering and other business management and shall implement the trainingplan together with the Personnel Division.k.Financial Division shall--- review the relevant Sub-clauses concerning financial matters in the Contract (by and between the Employer and the Company), theSub-Contract (by and between the Company and Subcontractor)and the purchase Contract (by and between the Company and theSupplier);--- participate in reviewing the qualification and selection of Sub-contractor and the Suppliers, and shall be responsible foranalysis and evaluation of the financial position and thepayment ability of the Subcontractor and the Suppliers.l.Legal Division shall--- be responsible for reviewing the legal documents of the Contract;QUALITY ASSURANCEResponsibility Fourth edition Revision status: 0 MANUAL--- ensure that the original copy of the Contract shall be in his custody. m.Purchase and Supply Division shall--- be responsible for the evaluation of the Suppliers, the purchase of the materials and the verification the purchased product, and shallsupervise and implement the Product Purchasing Procedures ;--- supervise and implement the Product Identification and Traceability Procedures, and the Handling, Storage, Packaging,Preservation and Delivery procedures;--- be responsible for purchasing machinery and equipment for the contracted construction works including the correspondingservicing;--- prepare the training plan for the personnel relating to purchase and supply of the materials, and shall implement the training plantogether with the Personnel Division.n.Technical Supply Division shall--- be responsible for the technical specifications of the Works and the standards management, and shall define the standards ofworkmanship and the construction methods, and shall superviseand implement the Inspection and Testing Procedures and theInspection and Test Status Procedures;--- participate in the tendering of the project, and shall prepare the construction plan;--- assist the Project in preparing the Construction organization, design and the major construction plan;--- be responsible for the development and the promotion of new technology, new workmanship and new construction materials;--- be responsible for the control of inspection, measuring and test equipment and the quantity measurement, and shall supervise andimplement the Control of Inspection, Measuring and TestEquipment Procedures;CSCEC CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALManagementResponsibilityCSCEC/DQA/QAM/98/ 001Page 8 of 10 pagesFourth edition Revision status: 0--- be responsible for preparing the corrective and preventive action on the nonconforming products of the project;--- prepare the training plan for the personnel in the technical system, and shall implement the training plan together with the PersonnelDivision.o.Mechanism and Electricity Division shall--- be responsible for the evaluation of the Supplier of mechanical and electrical equipment, and the procurement of the mechanical andelectrical equipment;--- be responsible for the second design of the mechanical and electrical installation project, and shall prepare the constructionplan for the mechanical and electrical installation project;--- assist the Project in the implementation of the mechanical and electrical installation project.p.Finishing and Decoration Division shall--- be responsible for the second design for the finishing and decoration project, and shall prepare the construction plan for thefinishing and decoration project;--- assist the Project in the supervision and the implementation of the finishing and decoration project.q.Project shall--- prepare the Project Quality Plan, and shall supervise and implement the Project Quality Plan;--- prepare the construction yearly, quarterly and monthly plan of the project ;--- prepare the guidelines for the operation, the operation procedures, and shall tell the details of the technical specifications andstandards to the Subcontractor;CSCEC CONSTRUCTION CO., LTD. QUALITY ASSURANCE MANUALManagementResponsibilityCSCEC/DQA/QAM/98/ 001Page 9 of 10 pagesFourth edition Revision status: 0--- prepare the plan of the project construction products;--- fill in the form for the evaluation to the Subcontractor and the Supplier;--- collect and take care of the quality records for the construction works.4.1.2.2ResourcesThe Company shall provide the necessary resources to satisfy theimplementation of the quality policy and the quality objectives. Thesuitability of the resources shall be evaluated by the managementreview. When the case of the non-suitability, the Managing Directorshall deal with the matter in question. The resources for incorporationin the works shall, in accordance with the provisions of the Contract,the character of the Works and the quality objectives, be defined whenthe project quality is planned, and shall be guaranteed and coordinatedby the CompanyThe Company shall take appropriate measures to assign the trainedpersonnel to verify and audit the quality system. The verification shallcover the whole process of the Work such as, the inspection, testingand supervising of the design, execution, installation and technicalservices, etc, and the inspection, testing and supervising of thecompleted works. All quality audits activity shall be carried out by thepersonnel independent of those having direct responsibility for theactivity being audited.4.1.2.3Management RepresentativeThe Managing Director shall appoint a member of the Company’smanagement as the Management Representative. The ManagementRepresentative shall arrange and supervise the implementation of thequality system. The Quality Assurance Division shall assist theManagement Representative in the implementation of the qualitysystem. For the detailed responsibility of the ManagementRepresentative, please see Sub-Clause 4.1.2.1 c of this Manual.。

最新的QA常见英文译中文表

最新的QA常见英文译中文表

BS plug tight Missing of power cord and instruction manual Silk-screen scratched Dirty Scratch mark Rating label upside down Scratches on metal tray Dirty on housing Wattage exceed spec Dirty on bottom housing Each unit put into a polybag with red color recycle symbol, together with instruction manual and poly foam then insert into the gift box 3 pcs per carton Sealed the carton with transparent adhesive tape in “工“shape Pad print missing Gap Poor painting on housing Switch button whiten Leakage at handle Mal-function of light foreign material (metal,plastic)Rust on heat plate Scratches on base cover Dirty power cord Less steam Defomation of metal ring Poor wiring Metal ring loose Poor assembly Small support bracket Large support bracket Large reflected dish Small reflected dish Large heater holder clamp Small heater holder clamp Cord buckle Rubber foot External tooth washer Spring washer Cable tie Power cord Base covEr Leadage NO steam Poor spray Broken handle Loose handle Lens broken Oil peel off from heating plate Loose lock Gap between on handle Poor plating on handle Lock tighten

Q7a(中英文对照)

Q7a(中英文对照)

Q7a(中英文对照)FDA原料药GMP指南Table of Contents 目录1. INTRODUCTION 1. 简介1.1 Objective 1.1目的1.2 Regulatory Applicability 1.2法规的适用性1.3 Scope 1.3范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1总则2.2 Responsibilities of the Quality Unit(s) 2.2质量部门的责任2.3 Responsibility for Production Activities 2.3生产作业的职责2.4 Internal Audits (Self Inspection) 2.4内部审计(自检)2.5 Product Quality Review 2.5产品质量审核3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.人员的资质3.2 Personnel Hygiene 3.2 人员卫生3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施4.1 Design and Construction 4.1 设计和结构4.2 Utilities 4.2 公用设施4.3 Water 4.3 水4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 排污和垃圾4.7 Sanitation and Maintenance 4.7 卫生和保养5. PROCESS EQUIPMENT 5. 工艺设备5.1 Design and Construction 5.1 设计和结构5.2 Equipment Maintenance and Cleaning 5.2 设备保养和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录6.1 Documentation System and6.1 文件系统和质量标准Specifications6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (MasterProduction and Control Records)6.4 生产工艺规程(主生产和控制记录)6.5 Batch Production Records (BatchProduction and Control Records)6.5 批生产记录(批生产和控制记录)6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7批生产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 控制通则7.2 Receipt and Quarantine 7.2接收和待验7.3 Sampling and Testing of IncomingProduction Materials7.3 进厂物料的取样与测试7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. PRODUCTION AND IN-PROCESSCONTROLS8. 生产和过程控制8.1 Production Operations 8.1 生产操作8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 工序取样和控制8.4 Blending Batches of Intermediates orAPIs8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9. 原料药和中间体的包装和贴签9.1 General 9.1 总则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与控制9.4 Packaging and Labeling Operations 9.4 包装和贴签操作10. STORAGE AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 入库程序10.2 Distribution Procedures 10.2 分发程序11. LABORATORY CONTROLS 11.实验室控制11.1 General Controls 11.1 控制通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的测试11.3 Validation of Analytical Procedures 11.3 分析方法的验证11.4 Certificates of Analysis 11.4 分析报告单11.5 Stability Monitoring of APIs 11.5 原料药的稳定性监测11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. V ALIDATION 12.验证12.1 Validation Policy 12.1 验证方针12.2 Validation Documentation 12.2 验证文件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4 工艺验证的方法12.5 Process Validation Program 12.5 工艺验证的程序12.6 Periodic Review of Validated Systems 12.6验证系统的定期审核12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析方法的验证13. CHANGE CONTROL 13.变更的控制14. REJECTION AND RE-USE OFMATERIALS14.拒收和物料的再利用14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 返工14.3 Reworking 14.3 重新加工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)16.协议生产商(包括实验室)17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 17.1适用性17.2 Traceability of Distributed APIs andIntermediates17.2已分发的原料药和中间体的可追溯性17.3 Quality Management 17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5稳定性17.6 Transfer of Information 17.6 信息的传达17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIs 18. 用细胞繁殖/发酵生产的原料药的特殊Manufactured by Cell Culture/Fermentation 指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and RecordKeeping18.2细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 18.4收取、分离和精制18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤19.APIs for Use in Clinical Trials 19.用于临床研究的原料药19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production 19.5 生产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 文件20. Glossary 20. 术语Q7a GMP Guidance for APIs Q7a原料药的GMP指南1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. 本文件旨在为在合适的质量管理体系下制造活性药用成分(以下称原料药)提供有关优良药品生产管理规范(GMP)提供指南。

质量保证计划QAP中英文版

质量保证计划QAP中英文版

质量保证计划QUALITY ASSURANCE PLAN客户名称 CLIENT :项目编号 ITEM NO. :订单日期 ORDER DATE :供货单位 VENDOR :设备代号 CODE :编制 PREPARATION:日期 DATE:审核 CHECK :日期 DATE:批准 APPROVAL :日期 DATE:XXXXX有限公司XXXXXXX Co., Ltd.1、适用范围和目的 Scope and purpose本质量保证计划适用于UPL项目产品的制造、检验和验收。

确保该产品的制造、检验和验收符合图样、规范、标准的要求。

This quality assurance plan is applicable to the manufacture, inspection and acceptance of UPL project products.To ensure that the manufacture, inspection and acceptance of the products meet the requirements of drawings, specifications and standards2、编制依据 Compilation basisTSG R0004-2009《固定式压力容器安全技术监察规程》TSG R0004-2009《Supervision Regulations on Safety Technology for Stationary Pressure Vessels》GB150.1~150.4-2011《压力容器》GB150.1~150.4-2011 《The Pressure Vessel》GB/T18442.1~5-2011《固定式真空绝热深冷压力容器》GB/T18442.1~5-2011《Fixed Vacuum Insulated Cryogenic Pressure Vessel》MAX/SC-2011《压力容器制造质量保证手册》MAX/SC-2011《Pressure Vessel Manufacturing Quality Assurance Manual》3、制造、检验依据的标准、规范或技术条件 Standards, specifications or technical conditions on which manufacturing or inspection is based 设计图样和工艺文件 Design drawings and process documentsTSG R0004-2009《固定式压力容器安全技术监察规程》TSG R0004-2009《Supervision Regulations on Safety Technology for Stationary Pressure Vessels》GB150.1~150.4-2011 《压力容器》GB150.1~150.4-2011 《The Pressure Vessel》GB/T18442.1~5-2011《固定式真空绝热深冷压力容器》GB/T18442.1~5-2011《Fixed Vacuum Insulated Cryogenic Pressure Vessel》JB/T4711-2003《压力容器涂敷与运输包装》JB/T4711-2003《Pressure Vessel Coating and Transportation Packaging》GB713-2008《锅炉和压力容器用钢板》GB713-2008《Steel plates for boilers and pressure vessels》GB9948-2006《石油裂化用无缝钢管》GB9948-2006《Seamless Steel Pipe for Petroleum Cracking》GB/T14976-2012《流体输送用不锈钢无缝钢管》GB/T14976-2012《Stainless steel seamless steel pipe for fluid conveying》NB/T47008-2010《承压设备用碳素钢和合金钢锻件》NB/T47008-2010《Carbon steel and alloy steel forgings for pressure equipment》NB/T47014-2011《Welding Process Assessment of Pressure Equipment》NB/T47015-2011《压力容器焊接规程》JB/T4730-2005《承压设备无损检测》JB/T4730-2005《Nondestructive testing of pressure equipments》GB/T25198-2010《压力容器封头》GB/T25198-2010《Pressure Vessel Head》HG/T20592~20635-2009《钢制管法兰、垫片、紧固件》HG/T20592~20635-2009《Steel pipe flanges, gaskets, fasteners》HG/T21514~21535-2005《钢制人孔和手孔》HG/T21514~21535-2005《Steel manholes and hand holes》5.1、低温液体储罐设备的检验和试验应符合设计图样、工艺文件及相关标准规范的要求。

QA/QC英文手册4版

QA/QC英文手册4版

Control No. : QS-CSE-M01QA/QC MANUALRev. 4Complied by: Li WeiWenChecked by:Ge Zhi Hai Wei ZhaoHongReviewed by:Lv ZhongYi Approved by: Zhou XueZhong Enforcement Date : Sept. 24, 2004Chiwan Sembawang Engineering Co Ltd44444The QA Engineer is directly responsible for the QA activities and reports to the QA Section Head. The following will be his main tasks:a) Performance of quality audit including major vendors andsubcontractors.b) Preparation of inspection and test procedures, Quality Plan and NDTextent etc.c) Liaison with project QC coordinator.d) Responsible for the calibration of measuring and testing equipment.e) Control of internal, external NCRs, and complaints from customer.f) Evaluation of work load for tenders.g) Review of NDT drawing.h) Document Filling systems and submission.4.6 Welding EngineerThe Welding Engineer is directly responsible for the control of welder qualifications and welding consumables. He reports to QA Section Head. The following will be his main tasks:a) Receive inspection of welding consumables together withprocurement personnel and preparing inspection report.b) Supervising and instructing the storage, baking and issuance ofwelding consumables.c) Organizing training and certifying of welder and welding operator.d) Evaluation the performance of welder and welding operator.4.7 Assistant QA EngineerThe assistant QA engineer reports to the QA Section Head and shall be responsible for following tasks :a ) Preparation of summary sheet for material traceability and QC/NDTinspection reports.b ) Typing Quality System Manuals, procedures, inspection formatsand project documents.The project QC coordinator is directly responsible for the quality control activities of the assigned project. He reports to the QC Section Head and has the responsibility of controlling and evaluating the QC inspectors engaged in his project. The following will be his main tasks:a) Implementation of QC procedures and assessment of QC inspectors.b) Liaison with personnel concerned including engineering , purchasingand PMT.c) Coordination with QA/QC Personnel including QA Engineer, NDTPersonnel and inspectors of various disciplines.d) Preparation of non-conformance reports (NCR)e) Consult with Project Manager to discuss quality mattersf) Control of inspection status.g) Release control4.9 QC InspectorThe QC inspectors of various disciplines report to project QC coordinator and shall be responsible for the following tasks:a) Performing and evaluating/witnessing required inspection and test .b) Preparation of inspection and test reports.c) Control of non-conformance items.d) Monitoring of the workmanship and inspection activities.e) Liaison with customer inspectors on quality matter concerned.f) Reporting of non-conformance items to project QC coordinator.g) Issue conformance release notice to products .6.1.7 The QA audit team shall discuss all quality aspect with thedepartment Managers on the spot and request for corrective action.6.1.8 The QA Engineer shall demand Department Managers responsiblefor the activity being audited to carry out their quality activities as per Quality System established by Company.6.1.9 Department Managers being audited should ensure that necessaryand appropriate corrective actions are taken to eliminate detected non-conformities and their causes within specified time.The QA/QC Department shall be responsible for the follow-up activities to the corrective actions, include the verification of the actions takenand the reporting of verification results.ll audit findings should be documented and/or submitted to GM/DGMs for information and / or comments.ll quality audit reports are treated as Company’s CONFIDENTIAL documents.The internal audit results shall be submitted to quality management review meeting for review.44444SCNCM: South China National Center MetrologyWhen the equipment is found to be outside of its requirements, QA/QC Department shall assess and record the validity of the previousmeasuring results, a NCR shall be raised and the equipment shallbe repaired and re-calibrated. If the conformance of products isaffected, the affected products shall be re-measured and/orrepaired.If the computer software is used in the monitoring and measuring of specified requirements, QA/QC Department shall confirm it havethe ability to satisfy the intended application prior to initial usedand reconfirm as necessary.46.5.4.1 All of welders and welding operations shall be qualified to relevantwelding codes before allow them to work on actual products.4Rev. No.: 47.1.2 Colour coding7.1.2.1Colour coding is used as a guide to assist identification during fabricationand shall be utilized whenever practical to assist traceability.7.1.2.1.1 Tubular pipes - to be spot painted besides internal / externalmarking.7.1.2.1.2 Steel plates - to be marked on two (2) diagonal edges of 59mmlength.7.1.2.2 What4 colours are to be applied to specific grade of steel shall bespecified in project Material Control Procedure prepared by QA/QCDepartment.7.1.3 Material traceability7.1.3.1 PieceNo. of all members fabricated shall be painted or hard stampedwith the stamping highlighted with paint for verification and futureidentification.7.1.3.2 HeatNo. shall be hard stamped and highlighted with paint on all primarystructural steel.7.1.3.37.1.3.4 Secondarystructural members and miscellaneous materials shall not have anytraceability records once they have been released for production .All handrails, stairs and landings, walkway are classified undersecondary structures. Other secondary members shall bedetermined by senior structural engineer in conjunction with thecustomer.7.1.4 Transfer of identification mark7.1.4.1 If theidentification numbers of materials and parts are obliterated duringfabrication or if the materials are divided into two or more parts, theoriginal markings shall be properly transferred before obliteration ofidentification numbers or dividing the materials.7.1.4.2 Theidentification mark transfer shall be performed by the Yardoperator and shall be verified by QC inspector. The identificationmark need to be transferred include, but not limited, heat No.,grade, etc.7.2.3.4Dimension inspection equipments shall be appropriately stored and adequately protected use, and verified or re-calibrated at appropriate interval as per the requirements of clause 6.4 to ensure their precision.7.2.4 Inspection by Customer and Notification7.2.4.1Customer may monitor and inspect all the activities included in group 1, group 2 and group 3, and shall have free access at all time to any part of CSE’s facilities that concerns the contract.7.2.4.2Custo mer shall be given notice on a daily basis of any inspection to be performed. This notice shall be given sufficiently in advance of said insp ection in order that customer may witness CSE’s inspection if so desired.7.2.47.4.4 Legend of status of inspection/test7.5.4.3 Prior to implementation of the disposition, the non-conformingitem and disposition shall be informed to customer representativeor the third party for his concurrence when required .。

质量手册翻译中英文术语表4p

质量手册翻译中英文术语表4p
质量经济性管理指南 Guidelines for managing the economics of quality
质量管理 培训指南 Quality management--Guidelines for training
English Chinese
receipt (入厂)接受,验收,进货
handling 搬运
测量设备的质量保证 第2部分: 测量过程控制指南 Quality assurance for measuring equipment--Part 2: Guidelines for control of measurement processes
质量手册编制指南 Guidelines for developing quality manuals
3.2.3 质量管理体系 quality management system
3.2.4 质量方针 quality policy
3.2.5 质量目标 quality objective
3.2.6 管理 management
3.2.7 最高管理者 top management
3.2.8 质量管理 quality management
质量体系审核指南 审核 Guidelines for auditing quality systems--Part 1: Auditing
质量体系审核指南 质量体系审核员的评定准则 Guidelines for auditing quality systems--Part 2: Qualification criteria for quality systems auditors
3.3.6 供方 supplier
3.3.7 相关方 interested party

QSR820质量手册英文版

QSR820质量手册英文版

1.0 PurposeThis qualitymanual (QM) defines LDR Spine policy.2.0 ScopeThe following ' Regulations ' and ' Standards ' are LDRiSabtequahty system:Applicable ' Regulations 'Where the term ' Regulations ' is usedtpi th e feegulation(s) listed below:«21 CFR Part 820: Food and Drug Administration Quality System Regulations (QSR)Applicable ' Standards 'Where the term ' Standard ' or ' Standards ' is use(quareey s ttenthsiandard(s) listedbelow:« ISO 13485 (7/2003): Medical devices - Quality ma nageme nt systems - Requireme nts for regulatory purposesApplicable Documents1. LIST 4-01 LIST, Master list of quality system docume nts3.0 Company background and historyLDR Spine was founded in 2004to focus on US sales and distribution of medical devices (ma nufactured by LDR Medical) to treat spinal disorders, and to obta in regulatory approvals for LDR Medical products in the US market. Products in clude spinal impla nts, in strume nts and sterilization trays.LDR Spine may also distribute devices for other companies in the spinal market.LDR Spine functions as a distributor and initial importer of medical devices, and is the US Agent for LDR Medical. LDR Spine may also design and develop medical devices for distribution in the US.LDR Spin eis located at:13785 Research Boulevard, Suite 200Aust in, Texas78750LDR Spine is the US en tity of the global LDR brand. The majority of desig n, developme nt, and man ufacturi ng fun cti ons are performed by LDR Medical which is located in Troyes, Fra nee. WhileLDR Spine has implemented a quality system to address the activities in the US (specifically con trol and distributi on), many quality system fun cti ons are the resp on sibility of, and addressed byLDR Medical.4.0 Subpart A -General Provisions4.1Sec. 820.5 Quality systemLDR Spine has impleme nted and maintains a quality system. The system shall be maintained and its effectiveness monitoredin accordanee with the ' Regulations'StandardsLDR.Spine has:*Ide ntified the processes n eeded for the quality system and their applicati on throughout the orga ni zati on*Determ ined the seque nee and in teracti on of these processes*Determ ined criteria and methods n eeded to en sure that both the operati on and con trol of these processes are effective*En sured the availability of resources and in formatio n n ecessary to support the operati on and mon itori ng of these processes*Mon itored, measured and an alyzed these processes*Impleme nted acti ons n ecessary to achieve pla nned results and main tai n the effective ness of these processesLDR Spine shall ensure control over processes that areoutsourced that may affect product conformity with requirements. Controlof such processes is identified within the qualitysystem.The man ageme nt of LDR Spi ne is committed to successfully impleme nting an effective quality system. This shall be accomplishedby:« Commu ni cat ing the importa nee of meeti ng customer requireme nts« Commu ni cat ing the importa nee of meeti ng the requireme nts specified in the'Regulations ' and ' Standards '« Establishi ng a quality policy and commu ni cat ing the importa nee of the quality policy« Establishi ng quality objectives« Performing management reviews« En suri ng the availability of resources5.0 Subpart B -Quality System Requirements5.1820.20 Management responsibility5.1.1Quality policyThe quality policy is the defining statement of the commitment to LDR Spine (in cludi ng man ageme nt with executiveresp on sibility) to meet its customer requireme nts and to comply with all regulatory requireme nts. LDR Spi nehas established the following quality policy:LDR Spine shall provide safe and effective devicesthat improve the quality of spine care and meetcustomer & regulatory requirementsMan ageme nt with executive resp on sibility shall en sure that the quality policy is un derstood, impleme nted,and maintained at all levels of the orga ni zati on.5.1.2OrganizationLDR Spine has established and maintains an adequate orga ni zati on structure to en sure that devices are designed, produced, accepted, and distributed in accorda nee with the regulatory requireme nts.Resp on sibility and authorityThe organizational structure of LDR Spine is contained in the organizational chart. The chart, along with jobdescriptions, define and document the resp on sibility, authority, and the in terrelati on of pers onnel who manage, perform, and verify work that affects quality. Every employee has resp on sibilities for quality as definedin the QM, SOPs and other documentation.If the responsible party is not available, authorized deputies may substitute for the resp on sible party. It isthe policy of LDR Spine that the supervisor for each employee is the authorized deputy for that employee .In addition,an employee may desig nate ano ther pers on to be a deputy by docume nting this fact in writing and providing thedocumentation to Quality. The designation of a deputy may be perma nent or temporaryIt is the resp on sibility of each deputy to only perform jobs for which they are qualified. Thus, a deputy mayhave to be trained (formally or via self-training) before performi ng a give n job.。

中英质量手册

中英质量手册

xx皮手套厂有限公司质量手册QM 001BCHAPTER TABLE / 目录:1.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY介绍XXX手套厂有限公司和XX皮厂 (2)2.DECLARATION OF THE BOARD董事会宣言 (4)3.QUALITY POLICY质量政策 (6)4.PURPOSE, SCOPE AND MANAGEMENT OF THE QUALITY MANUAL质量手册的目的、范围和管理 (9)5.DEFINITIONS定义 (10)6.QUALITY MANAGEMENT SYSTEM质量管理体系 (11)7.DESCRIPTIONS OF THE INTERACTIONS BETWEEN THE PROCESSES过程之间相互作用的表述 (13)8.DESCRIPTION OF THE PROCESSES程序描述 (16)ANNEX DOCUMENT / 附件:1.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY 介绍XX皮手套厂有限公司和XX皮厂1.1.General informations / 总说明1.2.Activities / 行为Xxx Tannery ensures the design and manufacturing of safety leathers and Xxx Safety Ltd of PPE (Personal Protective Equipment). All the products are made according to the current specifications and standards.确保xxx皮厂设计和生产的皮革和xxx皮手套厂有限公司设计和生产的个人防护用品都是依照当前的规范和标准制造的。

1.3.Staff and general organization on the 2006 / 03 / 01 职员和总体组织For details, refer to“Xxx Safety Ltd. and Xxx tannery organization chart” (HFO 002).详细资料, 参照“xxx皮手套厂、xxx皮厂组织图” (HFO 002)1.4.History / 历史Our business commercial relations between Europe and China have started in February 1975. 自从1975年2月开始,我们就建立了欧洲与中国的商业伙伴关系。

阿吉斯 绩效管理(英文版·第4版)教师手册 (1)

阿吉斯 绩效管理(英文版·第4版)教师手册 (1)

Using t he Instructor’s ManualThis manual includes resources that we sincerely hope will make your teaching of performance management easier and more enjoyable. We have “beta-tested” the majority of the content of this manual in our own performance management courses over the past decade. We have received very positive feedback from undergraduate, graduate, and executive students, and we hope you and your students will find these materials useful as well.In writing this manual, we thought about the challenges we have faced in teaching performance management over the years and how to address these challenges, including the need to have thorough PowerPoint slides that would make lecturing easier. Accordingly, the manual includes slides, which you can download from Chicago Business Press’ website athttps:///new-instructor-request, a listing of learning objectives for each chapter, outlines for each chapter that will help you organize your lectures, solutions to the cases included at the end of each chapter in the book, and additional cases and solutions for each chapter.Another challenge we faced as we taught this course is the need to allow students to practice the skills they learn throughout the book. Therefore, we have included a number of in- classroom case discussions and hands-on/role-play activities. We have used these cases and role-plays in our own examinations as well as for in-class exercises and discussions. They will be helpful in applying the knowledge learned in the book and allowing students to become more comfortable with the materials learned. Also, it will make your experience of teaching the course more enjoyable and interactive. In fact, because each chapter includes two case studies and two hands-on exercises (and more cases ar e also included in the instructor’s manual), the course could potentially be taught entirely using a case-based approach or an experiential learning approach depending on your preference and teaching style.Finally, we have included updated teaching strategies and multimedia resources in each chapter. The strategies will increase student interaction and engagement by providing thought-provoking questions that require students to integrate course material. The multimedia resources, which are also included in the PowerPoint files, consist of videos that have been selected to illustrate course concepts in a fun and engaging manner. These resources can be used to facilitate different learning styles by students.Taken together, we hope the PowerPoint slides, learning objectives, chapter outlines, cases and role-plays, and teaching strategies and multimedia resources will allow you to save time in delivering this course. We also hope these materials will allow your students to acquire knowledge and skills more effectively.Using the Test BankIn today’s world of accreditation standards and outcomes assessment, student testing has become an important issue. This test bank includes material that we hope will allow you to assess and document student learning effectively.The test bank includes three types of questions: (1) true/false, (2) multiple-choice, and (3) essay-type. The Instructor’s Manual includes the learning objectives for each chapter. The scoring suggested in this Test Bank uses these learning objectives and weighs them according to whether the student is required to demonstrate knowledge, understanding, and/or application of the concepts learned. Knowledge includes the use of correct terminology as well as the ability to list and describe concepts. Understanding goes beyond knowledge in that students are asked to explain the concept. Application requires students to describe how implementation of the concept would take place; this might include anticipation and resolution of problems in the given environment. The majority of application questions are included as part of the cases, which are part of the Instructor’s Manual and can be used for examinations as well as in-class discussions.The suggested scoring, in the event you wish to use the cases as part of your examinations, was created as follows. Each learning objective is assigned 2, 3, or 5 points depending on the complexity of the learning objective:Knowledge = 2Understanding = 3Application = 5Knowledge includes the use of correct terminology as well as the ability to list and describe concepts. Understanding goes beyond knowledge in that students are asked to explain the concept. Application requires students to describe how implementation of the concept would take place; this might include anticipation and resolution of problems in the given environment.A given answer might refer to a single, relatively simple learning objective and require the use of proper terminology (knowledge). Alternatively, an answer may require that the students explain a concept (understanding) or describe how to implement it (application). If a particular objective includes a knowledge, an understanding, and an application component, the scoring would be 1 X (2 + 3 + 5) = 10 points. If more than one learning objective is met in an answer, it would be possible to get more points. For example, if a question addresses three learning objectives requiring knowledge and understanding, then the resulting score would be 3 X (2 + 3) = 15 points.Each question has a code next to it noting (1) the recommended score assigned to the question, (2) the section of the chapter from which content is drawn, (3) the page numbers where the answers can be found, and (4) the specific learning objective(s) assessed with the question. For example, the code (Suggested points: 2, [9.1]); Pg. 260 LO: 1 means that the recommended number of points is 2 (i.e., the question is assessing mainly knowledge), the answer is found in section 1 of Chapter 9 on page 260, and that the question refers to learning objective 1. Suchlow-scoring questions are primarily true/false and multiple-choice questions. Similarly, the code (Suggested points: 10, .2[7.1], .2[7.2], .2[7.3], .2[7.4], .2[7.5]) LO: 2, 3, 4, 6, 7, 8 indicates a recommended score of 10 points, the question refers to sections 1, 2, 3, 4, and 5 in Chapter 7, and to learning objectives 2, 3, 4, 6, 7, and 8. The weights before the section numbers indicate that the question assesses content from each of the sections equally (i.e., a weight of .2 each). Such high-scoring questions are primarily essay-type questions.New to this Fourth EditionThis manual’s fourth edition includes many revisions and additions to the third edition. Overall, this fourth edition includes revisions to improve readability throughout all 11 chapters. More substantively, the fourth edition is vastly expanded and includes 52 cases and over 500 true/false, multiple-choice, and essay-type questions. So, this fourth edition of instructor’s manual includes an additional four to five cases per chapter. This expansion will be helpful to instructors who desire to teach the entire course using a case-based approach, which may be particularly useful for MBA-level as well as executive-level courses. The expansion of the test bank, which can be used for in-class exams or discussion, will also provide instructors greater flexibility. Finally, all PowerPoint files have also been revised to reflect revisions (e.g., inclusion of cases and multimedia resources) and updates in the book itself.Please do not hesitate to contact us if you have any suggestions on how to improve the materials in this Instructor’s Manual and Test Bank. We will be delighted to hear from you!Herman Aguinis, Ravi S. Ramani, and Nawaf AlabduljaderWashington, D. C.。

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Control No. : QS-CSE-M01QA/QC MANUALRev. 4Complied by: Li WeiWenChecked by:Ge Zhi Hai Wei ZhaoHongReviewed by:Lv ZhongYi Approved by: Zhou XueZhong Enforcement Date : Sept. 24, 2004Chiwan SembawangEngineering Co Ltd44444The QA Engineer is directly responsible for the QA activities and reports to the QA Section Head. The following will be his main tasks:a) Performance of quality audit including major vendors andsubcontractors.b) Preparation of inspection and test procedures, Quality Plan and NDTextent etc.c) Liaison with project QC coordinator.d) Responsible for the calibration of measuring and testing equipment.e) Control of internal, external NCRs, and complaints from customer.f) Evaluation of work load for tenders.g) Review of NDT drawing.h) Document Filling systems and submission.4.6 Welding EngineerThe Welding Engineer is directly responsible for the control of welder qualifications and welding consumables. He reports to QA Section Head. The following will be his main tasks:a) Receive inspection of welding consumables together withprocurement personnel and preparing inspection report.b) Supervising and instructing the storage, baking and issuance ofwelding consumables.c) Organizing training and certifying of welder and welding operator.d) Evaluation the performance of welder and welding operator.4.7 Assistant QA EngineerThe assistant QA engineer reports to the QA Section Head and shall be responsible for following tasks :a ) Preparation of summary sheet for material traceability and QC/NDTinspection reports.b ) Typing Quality System Manuals, procedures, inspection formatsand project documents.activities of the assigned project. He reports to the QC Section Head and has the responsibility of controlling and evaluating the QC inspectors engaged in his project. The following will be his main tasks:a) Implementation of QC procedures and assessment of QC inspectors.b) Liaison with personnel concerned including engineering , purchasingand PMT.c) Coordination with QA/QC Personnel including QA Engineer, NDTPersonnel and inspectors of various disciplines.d) Preparation of non-conformance reports (NCR)e) Consult with Project Manager to discuss quality mattersf) Control of inspection status.g) Release control4.9 QC InspectorThe QC inspectors of various disciplines report to project QC coordinator and shall be responsible for the following tasks:a) Performing and evaluating/witnessing required inspection and test .b) Preparation of inspection and test reports.c) Control of non-conformance items.d) Monitoring of the workmanship and inspection activities.e) Liaison with customer inspectors on quality matter concerned.f) Reporting of non-conformance items to project QC coordinator.g) Issue conformance release notice to products .6.1.7 The QA audit team shall discuss all quality aspect with thedepartment Managers on the spot and request for corrective action.6.1.8 The QA Engineer shall demand Department Managers responsiblefor the activity being audited to carry out their quality activities asper Quality System established by Company.6.1.9 Department Managers being audited should ensure that necessaryand appropriate corrective actions are taken to eliminate detected non-conformities and their causes within specified time.The QA/QC Department shall be responsible for the follow-up activities to the corrective actions, include the verification of the actions takenand the reporting of verification results.ll audit findings should be documented and/or submitted to GM/DGMs for information and / or comments.ll quality audit reports are treated as Company’s CONFIDENTIAL documents.The internal audit results shall be submitted to quality management review meeting for review.44444SCNCM: South China National Center MetrologyWhen the equipment is found to be outside of its requirements, QA/QC Department shall assess and record the validity of the previousmeasuring results, a NCR shall be raised and the equipment shallbe repaired and re-calibrated. If the conformance of products isaffected, the affected products shall be re-measured and/orrepaired.If the computer software is used in the monitoring and measuring of specified requirements, QA/QC Department shall confirm it havethe ability to satisfy the intended application prior to initial usedand reconfirm as necessary.46.5.4.1 All of welders and welding operations shall be qualified to relevantwelding codes before allow them to work on actual products.6.5.4.2 A badge will be issued by QA/QC Department to qualified welders4Rev. No.: 47.1.2 Colour coding7.1.2.1Colour coding is used as a guide to assist identification during fabricationand shall be utilized whenever practical to assist traceability.7.1.2.1.1 Tubular pipes - to be spot painted besides internal / externalmarking.7.1.2.1.2 Steel plates - to be marked on two (2) diagonal edges of 59mmlength.7.1.2.2 What4 colours are to be applied to specific grade of steel shall bespecified in project Material Control Procedure prepared by QA/QCDepartment.7.1.3 Material traceability7.1.3.1 PieceNo. of all members fabricated shall be painted or hard stampedwith the stamping highlighted with paint for verification and futureidentification.7.1.3.2 HeatNo. shall be hard stamped and highlighted with paint on all primarystructural steel.7.1.3.37.1.3.4 Secondarystructural members and miscellaneous materials shall not have anytraceability records once they have been released for production .All handrails, stairs and landings, walkway are classified undersecondary structures. Other secondary members shall bedetermined by senior structural engineer in conjunction with thecustomer.7.1.4 Transfer of identification mark7.1.4.1 If theidentification numbers of materials and parts are obliterated duringfabrication or if the materials are divided into two or more parts, theoriginal markings shall be properly transferred before obliteration ofidentification numbers or dividing the materials.7.1.4.2 Theidentification mark transfer shall be performed by the Yardoperator and shall be verified by QC inspector. The identificationmark need to be transferred include, but not limited, heat No.,grade, etc.7.2.3.4Dimension inspection equipments shall be appropriately stored and adequately protected use, and verified or re-calibrated at appropriate interval as per the requirements of clause 6.4 to ensure their precision.7.2.4 Inspection by Customer and Notification7.2.4.1Customer may monitor and inspect all the activities included in group 1, group 2 and group 3, and shall have free access at all time to any part of CSE’s facilities that concerns the contract.7.2.4.2Custo mer shall be given notice on a daily basis of any inspection to be performed. This notice shall be given sufficiently in advance of said inspection in order that customer may witness CSE’s inspection if so desired.7.2.47.4.4 Legend of status of inspection/test7.5.4.3 Prior to implementation of the disposition, the non-conformingitem and disposition shall be informed to customer representativeor the third party for his concurrence when required .。

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