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ASME NQA-1(1994)术语与定义中英文对照400 TERMS AND DEFINITIONSThe following definitions are provided to assure a uniform understanding of select terms as they areused in this Part.acceptance criteria: specified limits placed on the performance, results, or other characteristics of anitem, process, or service defined in codes, standards, or other requirement documents.audit: a planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance.Certificate of Conformance: a document signed or otherwise authenticated by an authorized individual certifying the degree to which items or services meet specified requirements.certification: the act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements.characteristic: any property or attribute of an item, process, or service thaits distinct, desirable, and mercial grade item: an item satisfying the following;(a) not subject to design or specification requirements that are unique to nuclear facilities; (b) used in applications other than nuclear facilities;(c) to be ordered from the manufacturer/supplieron the basis of specifications set forth in the manufacturers published product description (for example, a catalog).computer program: a combination of computer instructions and data definitions that enables computer hardware to perform computational or control functions.condition adverse to quality: an all-inclusive term used in reference to any of the following: failures,malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverse toquality is one which, if uncorrected, could have a serious effect on safety or operability.configuration: the physical, functional, and operational characteristics of the structures, systems, components, or parts of the existing facility.configuration item3 (software): a collection of hardware or software elements treated as a unit for the purpose of configuration control.configuration management: the process that controls the activities, and interfaces, among design, construction, procurement, training, licensing, operations, and maintenance to ensure that the configuration of the facility is established, approved, and maintained.corrective action: measures taken to rectify conditions adverse to quality and, where necessary, to preclude repetition.design, final: approved design output documents and approved changes thereto.design authority: the organization having the responsibility and authority for approving the designbases, the configuration, and changes thereto.design bases: that information which identifies the specific functions to be performed by a structure, sys-tem, or component of a facility, and the specific values or ranges of values chosen for controlling parameters as reference bounds for design. These values may be (1) restraints derived from generally accepted ”state-of-the-art” practices for achieving functional goals, or (2) requirements derived from analysis (based on calculations and/or experiments) of the effects of a postulated accident for which a structure, system, or component must meeitt s functional goals.design change: any revision or alteration of the technical requirements defined by approved and issued design output documents and approved and issued changes thereto.design input: those criteria, parameters, design bases, regulatory requirements, or other design requirements upon which detailed final design is based.design output: drawings, specifications, and other documents used to define technical requirements of structures, systems, components, and computer programs.design process: technical and management processes that commence with identification of design input and that lead to and include the issuance of design output documents.design review: a critical review to provide assurance that the final design is correct and satisfactory.deviation: a departure from specified requirements.document: any hard copy or electronic (text or (00) graphic) information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. A document is not considered to be a quality assurance record until it satisfies the definition of a quality assurance record as defined in this Standard.document control: the act of assuring that documentsare reviewed for adequacy, approved for release by authorized personnel, and distributed to and used at the location where the prescribed activity is performed.electronic document: a document stored in a form (00) (.e., magnetic and optical tapes or disk) that is accessible only by a computer.guidance: a suggested practice that is not mandatory in programs intended to comply with this Standard. The word “should” denotes guidance; the word ”shall” denotes a requirement.inspection: examination or measurement to verify whether an item or activity conforms to specified requirementsitem: an all-inclusive term used in place of any of the following: appurtenance, assembly, component,equipment, material, module, part, structure, subassembly, subsystem, system, or unit.measuring and test equipment (M & TE): devices or systems used to calibrate, measure, gage, test, or inspect in order to control or acquire datato verify conformance to specified requirements.nonconformance: a deficiency in characteristic, documentation, or procedure that renders the quality ofan item or activity unacceptable or indeterminate.objective evidence: any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or tests which can be verified.Owner: the organization legally responsible for the construction and/or operation of a nuclear facility including but not limited to one who has applied for, or who has been granted, a construction permit oroperating license by the regulatory authority having lawful cedure: a document that specifies or describes how an activity is to be curement document: purchase requisitions, purchase orders, drawings, contracts, specifications, or instructions used to define requirements for purchase.Purchaser: the organization responsible for establishment of procurement requirements and for issuance or administration, or both, of procurement documents.qualification, personnel: the characteristics or abilities gained through education, training, or experience, as measured against established requirements, such as standards or tests, that qualify an individual to perform a required function.qualified procedure: an approved procedure that has been demonstrated to meet the specified requirements for its intended purpose.quality assurance (QA): all those planned and systematic actions necessary to provide adequate confidence that a structuresy, stem, or componentw ill perform satisfactorily in service.quality assurance record: a completed document that furnishes evidence of the quality of items and/or activities affecting quality. In addition to paper (.e.,2001 0757b70 Ob22b59 2TT ASME NQA-t -2000 hard copy), records may include electronic documents and specially processed records such as radiographs, photographs, negatives, and microforms.receiving: taking delivery of an item at a designated location.repair: the process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement.rework: the process byw hich an item is made to conform to original requirements by completion or correction.service: the performance of activities such as design, fabrication, inspection, nondestructive examination, repair, or installation.shall: See definition of the term guidance.should: See definition of the term guidance. Software computer programs and associated documentation and data pertaining to the operation of a computer system.special process: a process, the results of which are highly dependent on the control of the process or the skill of the operators, or both, and in which the specified quality cannot be readily determined by inspection or test of the product.Supplier: any individual or organization who furnishes items or services in accordance with a procurement document. An all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, consultant, and their subtier levels.testing: an element of verification for the determination of the capability of an item to meet specifiedrequirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.traceability: the ability to trace the history, application, or location of an item and like items or activitiesby means of recorded identification. use-as-is: a disposition permitted for a nonconforming item when it has been established that the item is satisfactory for its intended use.waiver: documented authorization to depart from specified requirements.-400 术语和定义为保证对本篇标准所用术语理解的一致性,下面提供了所用术语的定义。验收准则:在规范、标准、或其他要求文件中规定的物项、过程、或服务的性能、结果、和其他特性所设定的限制范围。监查:一种有计划并文件化的活动,通过对客观证据的研究、检查、或评价,以确定己建立的程序、说明书、图纸、及其他适用文件的合适性、实施的符合性和有效性。监查不应和过程控制或产品验收等单一目的所作的监督和检验活动混淆。合格证书:由授权的个人签字或用其他方式证实,证明物项或服务满足确定的要求的文件。证书确认:依照确定的要求,以书面的形式判定、验证并证实人员的资格、过程、程序、物项的符合确定的要求。特性:物项、过程或服务固有的、或期望的、可测量的性能或属性。商品级物项:满足下列要求的物项:(a)不受那些设施或活动特定的设计或技术规格书要求的支配:(b)适用于除那些特定的设施或活动的之外的用途;(c)根据制造商公布的产品说明书(例如产品目录)列出的技术规格,从制造商/供应商订货的物项。商品级物项:影响安全功能,但不必按本标准要求设计和制造的结构、或系统、组件、零件。商品级服务(1)(2):不必依照本标准要求提供的服务。计算机程序:能使计算机硬件执行计算和控制功能的指令和数据的组合。有损质量状况:所有下列的任何一项所涉及的条件:损坏、失灵、不充分、缺陷项和不符合项。严重的有损质量状况则是,若不纠正则会对安全或可操作性有严重影响的那种条件。构成特征(Configuration):现存设施的构筑物、系统、或部件、零件的物理、功能的和运行方面的特性。构成特征项(组态-软件):在一个单元里以构成特征控制为目的的软件或硬件单元集合。构成特征管理:在设计、建造、采购、训练、许可、运行和维修中,对活动和接口进行控制的过程,以确保设施性能构成特征的建立、批准和保持。 设计基础:(Design Bases)一种资讯,该资讯确定设施的结构、系统和组件实现的具体功能,并确定作为设计参照边界选定的控制参数的具体数值及数值范围。这些数值可以是:(a)一些约束,这些约束是由普遍接受的,为实现功能目标的“技艺水平“的实践中导出的;(b)一些要求,这些要求是(基于计算和/或实验)分析一个假设事故效应导出的,在该事故中结构、系统或部件必须满足它的功能目标。设计变更:对己批准和发布的设计输出文件,或其变更中的技术要求的任何修正和改变。设计输入:作为详细的最终设计基础的准则、参数、设计基础、法规要求、或其他的设计要求。设计输出:用以确定构筑物、。系统、部组件和计算机程序的图纸、规格书和其他文件。设计过程:一种技术和管理过程,它从确定设计输入开始,直至形成且包括设计输出文件的发布。设计评审:为使最终设计正确和满意而提供保证的严格审查。偏离(差):偏离事先规定的要求。文件:任何书面的、图形的、或者电子的资料,用于描述、确定、详细规定、报告、或证明活动、要求、程序和结果。在未满足本标准的质量保证记录定义以前的文件不是质量保证记录。纠正行动:纠正有损质量状况,并防止重复发生所采取的措施。关键特性:商品级的物项或服务之重要的设计、材料及运行特性,如一旦已被验证,便将为该物项或服务实现其预期的安全功能提供合理的保证。授予:(Dedication)依照本标准实施的一个验收过程,为商品级的物项或服务项能够成功地实现其预期的安全功能提供一种合理的保证,因而在安全功能方面,等同于遵照本标准的要求提供的物项或服务。授予实体:实行授予过程的单位。最终设计:已批准的设计输出文件和已批准的设计变更。设计管理当局:有责任并权力批准设计基础、构成特征及其变更的管理机构。文件控制:一种保证行动,包括文件经严格审查、由授权人员的批准和发放,并分发到履行该活动的场所使用。电子文件:贮存在磁、或光媒体中,一般只有用计算机才能存取的文件。导则:在大纲中不强制遵循本标准的建议性的规定。词“须“(s

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