美国FDA 医疗器械体系法规QSR820中英文对照(七)

Subpart H--Acceptance Activities 验收措施Sec. 820.80 Receiving, in-process, and finisheddevice acceptance.进货、中间品和

Subpart H--Acceptance Activities  验收措施

Sec. 820.80 Receiving, in-process, and finisheddevice acceptance.进货、中间品和成品器械的验收

(a) General.Each manufacturer shall establish and maintain procedures for acceptanceactivities. Acceptance activities include inspections, tests, or otherverification activities.

    (a)概述。制造商应当建立和维护用于验收措施的规程。验收活动包括检验、试验或其他确认活动。

(b) Receivingacceptance activities. Each manufacturer shall establish and maintainprocedures for acceptance of incoming product. Incoming product shall beinspected, tested, or otherwise verified as conforming to specifiedrequirements. Acceptance or rejection shall be documented.

    b)进货验收措施。制造商应当建立和维护用于验收进货产品的规程。进货产品应当经过检测、测试或其他确认方式,并满足其特定要求。验收或拒收应当予以记录。

(c) In-processacceptance activities. Each manufacturer shall establish and maintainacceptance procedures, where appropriate, to ensure that specified requirementsfor in-process product are met. Such procedures shall ensure that in-processproduct is controlled until the required inspection and tests or otherverification activities have been completed, or necessary approvals arereceived, and are documented.

    c)中间产品的验收措施。制造商应当建立和维护相应的中间品验收规程来保证中间产品符合其特定要求。该规程应当保证直到所需要的检测、试验或其他确认活动得以实施或得到必须的批准,中间产品一直处于受控状态。所有的控制措施应当予以记录。

(d) Finalacceptance activities. Each manufacturer shall establish and maintainprocedures for finished device acceptance to ensure that each production run,lot, or batch of finished devices meets acceptance criteria. Finished devicesshall be held in quarantine or otherwise adequately controlled until released.Finished devices shall not be released for distribution until:

    d)成品的验收措施。制造商应当建立和维护成品器械验收的规程来保证成品器械批或批、每个产品的运行符合其验收标准。成品器械在其放行前应当单独存放或其他适当的方式进行控制。成品器械直到下述工作完成后才可以放行用于销售:

(1) The activities required in the DMR arecompleted;

    1DMR要求的验收得以完成;

(2) theassociated data and documentation is reviewed;

    2)相应的数据和文件已经得到审核;

(3) the release is authorized by the signatureof a designated individual(s); and

    3)经过有权限的人员签名批准放行;并

(4) the authorization is dated.

    4)批准日期得以记录。

(e) Acceptancerecords. Each manufacturer shall document acceptance activities required bythis part. These records shall include:

    e)验收记录。制造商应当记录本部分要求的验收措施。记录应当包括:

(1) The acceptance activities performed; 实施的验收措施;

(2) the dates acceptance activities areperformed; 实施验收措施的日期;

(3) the results; 验收结果;

(4) the signature of the individual(s)conducting the acceptance activities; and 实施验收活动人员;并

(5) whereappropriate the equipment used. These records shall be part of the DHR.相应的使用设备。这些记录将作为DHR的一部分。

Sec. 820.86 Acceptance status. 验收状态

Each manufacturer shall identify by suitablemeans the acceptance status of product, to indicate the conformance ornonconformance of product with acceptance criteria. The identification ofacceptance status shall be maintained throughout manufacturing, packaging,labeling, installation, and servicing of the product to ensure that onlyproduct which has passed the required acceptance activities is distributed,used, or installed.

    制造商应当通过适当的方式来标识产品的验收状态,来标明是否符验收标准。验收状态的标识应当贯穿于产品生产、包装、贴标、安装、服务的全过程从而保证只有经过符合验收措施要求的产品才可以销售、使用或安装。

SubpartI--Nonconforming Product 不合格品

Sec.820.90 Nonconforming product.不合格品

(a) Controlof nonconforming product. Eachmanufacturer shall establish and maintain procedures to control product thatdoes not conform to specified requirements. The procedures shall address theidentification, documentation, evaluation, segregation, and disposition ofnonconforming product. The evaluation of nonconformance shall include adetermination of the need for an investigation and notification of the personsor organizations responsible for the nonconformance. The evaluation and anyinvestigation shall be documented.

(a)不合格品的控制。制造商应当建立和维护相应的规程来控制不符合特定要求的产品。该程序应当对不合格品标识、记录、评估、隔离和处理进行规定。对不合格品的评估应当包括明确的调整的需求以及向对不合格品负责的人或组织进行告知。评估和任何的调整都应当予以记录。

(b) Nonconformity review and disposition. 不合格品的审核和处理

(1) Eachmanufacturer shall establish and maintain procedures that define theresponsibility for review and the authority for the disposition ofnonconforming product. The procedures shall set forth the review anddisposition process. Disposition of nonconforming product shall be documented.Documentation shall include the justification for use of nonconforming productand the signature of the individual(s) authorizing the use.

    (1)制造商应当建立和维护相应规程来界定审核职责以及不合格处理的权限。该程序应当阐明审核和处置过程。不合格品的处置应当予以记录。记录应当包括不合品使用的理由以及批准使用人员的签字。

(2) Eachmanufacturer shall establish and maintain procedures for rework, to includeretesting and reevaluation of the nonconforming product after rework, to ensurethat the product meets its current approved specifications. Rework andreevaluation activities, including a determination of any adverse effect fromthe rework upon the product, shall be documented in the DHR.

    (2)制造商应当建立和维护包括在返工后重新对不合格品进行试验和再评估的返工规程来保证重加工产品符合其现行批准的标准。包括确定返工是否给产品带来不利影响的返工和再评估活动应当在记录在DHR中。

SubpartJ--Corrective and Preventive Action 纠正和预防措施

Sec.820.100 Corrective and preventive action.纠正和预防措施

(a) Eachmanufacturer shall establish and maintain procedures for implementingcorrective and preventive action. The procedures shall include requirementsfor:

    (a)制造商应当建立和维护用于实施纠正和预防措施的规程。该规程应当包括以下要求:

(1)Analyzing processes, work operations, concessions, quality audit reports,quality records, service records, complaints, returned product, and othersources of quality data to identify existing and potential causes ofnonconforming product, or other quality problems. Appropriate statisticalmethodology shall be employed where necessary to detect recurring qualityproblems;

    (1)分析工艺、操作、让步接收、质量审计报告、质量记录、服务记录、投诉、返厂产品、其他质量数据的资源来找出存在的和潜在的导致不合格品或其他质量问题的原因。应采用适当的统计技术以发现重复出现的质量问题。

(2)Investigating the cause of nonconformities relating to product, processes, andthe quality system;

    (2)调查与产品、工艺和质量体系相关联的不合格品产生的原因。

(3)Identifying the action(s) needed to correct and prevent recurrence ofnonconforming product and other quality problems;

    (3)识别用于纠正和预防不合格品和其他质量问题再发生所需的活动

(4)Verifying or validating the corrective and preventive action to ensure thatsuch action is effective and does not adversely affect the finished device;

    (4)确认和验纠正和预防措施来保证措施有效,并对成品器械不产生不利影响。

(5)Implementing and recording changes in methods and procedures needed to correctand prevent identified quality problems;

    (5)实施和记录用于纠正和预防已经确定质量问题方法和程序的变更。

(6)Ensuring that information related to quality problems or nonconforming productis disseminated to those directly responsible for assuring the quality of suchproduct or the prevention of such problems; and

    (6)保证与质量问题或不合格品有关的信息能够传递给那些直接对保证这类产品质量负责的或是能够预防这些问题的人。

(7)Submitting relevant information on identified quality problems, as well ascorrective and preventive actions, for management review.

    (7)提交已确认的质量问题的相应信息和纠正预防措施进行管理审核。

(b) Allactivities required under this section, and their results, shall be documented.

    (b)在本节下要求的所有措施、结果都应当予以记录。

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