修理电视机1Is there a documented quality policy?是否有文件化的质量方针？
a. Does it address objectives and define its commitment to quality? 是否明确目标并界定了其对质量的承诺？
b. How does the company ensure the quality policy is understood, implemented and maintained at all levels? 如何确保公司的质量方针在各层级间的理解，实施和维护？
2Is there a management reprentative who has defined authority and responsibility for implementation and maintenance of the quality systems? 是否有定义了管理者代表，并拥有实施和维护质量体系的的权力和责任？
3Are the organizational structure, responsibilities and authority of management personnel documented? 组织架构是否文件记录管理人员的责任和权力？
4Does upper management periodically review and approve all aspects of the quality system to ensure its continuing
suitability and effectiveness? 高层管理人员是否定期审查和批准质量体系内容，以确保其可持续的适宜性和有效性？a. Are quality records and indicators included in this review? 质量记录和指标有列入
审查内容吗？
b. Is there a documented process for the reviews? 是否有审查工作的文件程序？
c. Are there documented records of the reviews?有无文件体现审核记录？
1Does the facility have a formal QA System? 是否有质量保证体系
a. Are the procedures documented?有受控程序吗？
2Is the QA Manual and/or Inspection Plan approved by company management?质量保证手册“和/或检查计划是否经公司管理层批准？
a. Does it include or reference to procedures?手册是否包含或引用程序
b. Does it outline the structure of the quality system?它体现出质量体系的结构吗？
c. Request a copy of the manual. 索取手册副本
3Is there a flow chart for the manufacturing process? If “yes”, give us a copy.是否有制造过程的流程图？如果“有”，给我们一个副本。
4Have all process affecting product quality/performance been identified?所有影响产品质量/性能的关键流程有被定义？a. Are they controlled?他们是否有控制
1Is there a documented procedure to control and verify the design of the product?有无受控的程序去控制和验证产品的设计？2Does the procedure include the establishment of a design plan?程序是否包括设计方案的建立？
a. Does the plan define responsibilities/activities of qualified personnel?计划是否定义合格的人员及其职责？
b. Does the plan describes the interfaces between different departments from the design until the transfer in
manufacturing?计划有无描述从设计到生产不同部门之间的转移对接窗口？
c. Does the plan include review, update and approval of plans as design and development evolve?计划内是否包括对设计和开发发展过程的审查，更新和批准计划？
3Are design inputs identified, documented and reviewed?设计有无被确定，受控和审查？
a. Do they address the intended u including the needs of the ur and the patient?他们是否有明确预定用途，包括用户和患者的需求？
4Are design outputs documented?设计输出有无记录受控？
a. Are they verified and validated against stage inputs?他们有无核实并针对现阶段进行验证？
b. Do they contain acceptance criterias ? 设计是否包含可接受的要求特性吗？
c. Are they reviewed and approved prior to relea?设计在发布之前是否有审查和批准呢？
A. Management Responsibility 管理责任
B. Quality System 质量体系
C. Design Control 控制设计
5Are design reviews planned and conducted at appropriate stages?有无设计评估计划，并进行适当的阶段性评论？a. Do they involve reprentatives from all functions? Do they includes Risk Analysis ?设计是否包含及代表涉及的所有功能？包括风险分析吗？
b. Do assigned individuals have direct responsibility for the design development? 设计开发直接责任是否有分配到个人？
c. Are the reviews documented? 这些评估有记录吗？
6Are procedures documented for verifying and validating the device design?是否有核查和验证设备设计的程序？7Is design verification performed at appropriate stages and are results recorded ?是否在适当阶段进行设计验证，并记录结果？8Does validation include testing of production units under actual or simulated u conditions before distribution?验证是否包含对产品的实际或模拟使用条件测试？
9Does validation include software validation and risk asssment?验证是否包括软件验证和风险评估？#Is there a procedure for translating the design basis into production specifications?
是否有设计依据转化成实际产品规格要求的程序？
#Are design changes identified, reviewed and approved by authorized personnel prior to implementation?
设计变更落实前是否由授权人员进行识别、审核及批准。
#Is there a documented history file for each product design?每个产品设计是否有独立的文件历史档案a. Does it contain or refers to all records that show the design was developed according to the design plan?
是否有记录并显示设计开发的落实符合设计计划？
1Is there a documented procedure regarding document control?是否有文件控制程序？
a. Does the procedure include hard copies, electronic medias, and applicable external origin documents (i.e., customer furnished drawings and specifications)?程序中是否包含硬件备份、电子文档及外来文件（如客户填报图纸及要求）2Are documents reviewed and approved by authorized personnel prior to u?程序发放前是否获得授权者审核并批准3Is current revision status controlled with a master list or equivalent?现有修订版本状态有被总表记录控制4Are documents available at all esntial locations? 文件在所有重要地点有效使用吗？
5Is there a procedure to remove obsolete document from u or prevent from inadvertent u?是否有过时的文件的回收程序，以防止误用？6Are any obsolete documents retained?任何作废文件有保留？
7Are document changes reviewed and approved by original approving functions?文件变更是否被原职能进行审核及批准a. Do reviewers have access to pertinent background informations ?评论是否有相关的变更背景信息的访问？b. Is the nature of the change identified in the document or attachments?文件或附件中有无定义变更的性质及内容？8Are controls in effect to assure that the current applicable revision of documents are in u at the time of production and inspection operations?有效的控制，以保证在生产和检验时，使用最新版本的修订文件？
9Are the purcha orders reviewed to ensure that the revision written on the order match with the work order's revision?采购订单是否被审核确保订单内的版本描述对应生产工单版本
#Do change control records the following informations : the description of the change, the affected documents, approving authority, approval date and effective date? 变更控制有记录以下信息：变化说明，受影响的文件，批准机关，批准日期和生效日期？#If the document databa is electronic, has the system been validated? How is access controlled? 如果是电子文档数据，系统是否被验证？如何控制访问权限？
1Is there a procedure for supplier (subcontractor) lection, purchasing or otherwi received product or rvice? 是否有对供应商的管理控制程序？
a. Is the supplier verified or approved?供应商是否被核实或批准？
2Are suppliers evaluated and lected bad on their ability to provide acceptable quality? 是否评价和选择供应商，以提供可接受的质量？
D. Document and Data Control 文件及数据控制
E. Purchasing Control 采购控制
3Do each supplier has an inspection plan applicable or a certificat of compliance program for each products ? 是否有对每个供应商进行产品适用性或证书符合性的审查计划？
4Is there a list of approved suppliers?是否有合格供应商清单
5Do purchasing documents contain enough information to clearly describe the product ordered and its revision (if applicable)? 采购文件是否包含足够的信息清楚地描述产品订单要求及最新版本（如适用）
6Do they include an agreement to notify the supplier of any changes on the product?采购文件内对于供应商的任何产品变更是否有协议7Are the purchasing documents reviewed and approved for adequ
acy prior to relea? 采购订单发放前是否充分被审核并批准8Are the verification arrangements contained in the purchasing documents or in other official specification documents ?(i.e., receiving inspection, test verification, performance evaluation, relea criteria).采购文件或其他正式的规范性文件中是否包含核查检验的安排？ （即，来料检验，测试验证，绩效评估，验收标准）
1Are there procedures for the control of customer (as ArjoHuntleigh)-supplied product? 是否有客供件控制程序？2Is any damaged or nonconforming customer (as ArjoHuntleigh) owned product recorded and reported to the customer?对于不良客供件是否有记录及报告给客户？
1Are there procedures for identifying product at all times to prevent mixups?是否有全程的产品标识及可追溯性管理程序？2Are there procedures for identifying individual product or batches that facilitate corrective action?产品是否有独立标志或批次标识的程序管理，有利于纠正行动程序运行。
3Are traceability records maintained for product or rvice made for ArjoHuntleigh?有无为客户提供保持产品的可追溯性资料的服务。我是猫读书笔记
a. If so, for how long??如有，多久期限？
4Are there procedures for lot identification, inspection status and traceability throughout manufacturi
ng, delivery, and installation?是否有产品制造、运输及安装过程的批次标识、检验状态、追溯性的程序文件？
5Does the tracability allow to confirm that each production lot was made with the version of the specification relead at the time of manufacturing? 追溯程序是否可以确认每个生产批，并是按照产前指定的版本要求进行落实6Are there documented procedures to prevent cross contamination (mixed up) between lots? 是否有书面程序，以防止批次间的交叉污染（混合）？1Are process clearly identified, conducted, controlled and monitored for each product ?程序是否明确指出，进行控制和监测每个产品的过程吗？
a. If “yes”, how?如是，如何进行？
2Is there a documented approval procedure concerning new process/equipments or their modification (ex: PFMEA)? 对于新工艺/设备或其它变更是否有确认的文件审批程序？
3Are there documented instructions for the control of production process (including in-process,parameters/product
characteristics, inspection operations and testing)? 是否有生产过程控制记录的说明（包括进程中，
参数/产品4During production, if a process deviation is obrved, is it adresd and corrected?在生产过程中，如果观察过程中出现偏差，是否被指出和纠正呢？
a. U of suitable equipment and work environment ?是否使用合适的设备及工作环境？
b. Are there environmental control systems including periodic inspections ?是否有包含定期检查要求的环境控制程序？
c. Compliance with governing documents/procedures.遵守当地政府法律法规程序
d. Process and equipment approval 工艺和设备的批准
5Do written procedures authorize the u of visual reference or boundary samples?是否与书面程序授权可使用目测参考件或极限样板？
6Is there an equipment preventive maintenance program?是否有设备的预防性维修计划？
H. Production & Process Control 生产过程控制
F. Control of Customer Supplied Product 客供件的控制
G. Product Identification & Traceability 产品标识及可追溯性
7Is there a schedule of periodic inspection/maintenance and is it folowed ? 是否有计划表定期检查维护的落实
8Are process parameters requiring adjustment on or near each equipment ?是否每台设备或附近需要调整工艺参
数？
9Is there a formal process for validation of changes? 是否有验证变化过程（稳定性）的程序？
a. Are changes validated or verified before approval and implementation ?有无实施前进行验证或核实批准变化？
b. Are validation/verification results documented? 有审定/核查结果记录吗？
#Are there procedures to prevent contamination of equipment or
product? (i.e., food, drink, smoking, pest control policies, clothing, cleanliness, hygiene) ?是否有程序防止污染设备或产品？（即食品，饮料，吸烟，病虫害防治的政策，服装，清洁，卫生）“？
#Is the building of suitable design and sufficient space to perform necessary operations? 建筑是否合适的设计，有无
建设足够的空间来执行必要的操作吗？
#Are there procedures for management of non-conforming manufacturing materials?是否有不合格品管理程序？
#Is the quality systems computer software validated according to a documented protocol?是否根据文件协议验证质量体系计算机软件？
#Are software changes validated before approval and issuance?有无在发放前验证和审批件变化？
#Are software validation records maintained?有无保持软件的验证记录？
#Are there documented procedures for special process?是否有特殊工艺的文件程序？
a. Do they require process qualification?是否需要过程的资格验证？
b. Do they require qualified operators?是否需要操作者资格验证？
c. Do they require continuous monitoring?是否进行持续监测？
d. Do they require control of process parameters?是否对过程参数进行控制？
#Are there documented procedures for control, u and retest of materials with expiration or shelf-life dates/conditions ? 是否有书面程序明确材料的控制、使用、到期日期或保质期/条件吗？
#Are there documented procedures for the approval, u, and removal of manufacturing materials (cleaners, solvents, etc.)?是否有书面程序明确批准，制造材料的使用和去除（清洁剂，溶剂等）？
I. Inspection and Testing检验测试
1Are there documented procedures for inspection and testing to ensure that the product meets specified requirements? 是否有记录进行检查和测试的程序，以确保产品符合规定要求？
2Is incoming product verified prior to u?产品投入使用前有进行来料验证？
a. If material is received on certification, is the certificate reviewed as part of the receiving operation?如收货时附带材
质证书，该证书是否作为来料的一部分进行评估确认？
b. Are certificates of compliance or analysis challenged and results audited? 这些符合性声明书是否作为或影响评
估结果。
c. How long are certificates retained?证书保留多久？
3Is in-process or incoming product verified, identified, recorded and controlled prior to be relead for production?生产前使用前，在进程或来料进行产品验证，鉴定，记录和控制？
4Is final product to be relead for distribution held until all requirements have been satisfactorily completed and
data/documentation authorized?产品释放组装前有确认满足要求，且相关数据文件获得批准。
5Do inspection and test records show pass/fail acceptance criteria?检验和试验记录是否显示合格/不合格的验收标
准？
a. Are they maintained?是否有保存维护
b. If “yes”, for how long?如有多久
6Are there procedures for the control, proofreading, and issuance of labeling items? 是否有对标签进行控制、校对以
及发行的程序？
7Does the system allows to keep only current labels and the destruction of obsolete labels?系统是否允许保持目前唯
一的标签和销毁过时的标签吗？
J. Inspection, Measuring, and Test Equipment检验监视测试设备
1Is there a documented calibration program for measuring and testing equipment? Does it include the following: 是否有检验监视测试设备的控制程序，程序内是否包含以下
a. Method to u 使用方法
b. Accuracy and precision 准确度及精密度
c. Type of equipment to u 使用的设备类型
d. Calibration Frequency 校准频率
e. Acceptance criterias 验收特性（标准规范）
结婚登记需要什么证件2Is reliability and repeatability testing or other suitable statistically valid methods ud to qualify measuring and test equipment?是否有可靠性和可重复性测试或其他合适有效的统计方法，用于验证测量和试验设备？3Is all equipment ud for determining product/process quality identified and calibrated?用于确定产品/过程质量的所有设备有被鉴定和校准？
4Are standards ud traceable to national or international standards? Example: NIST in the US?使用标准是否可追溯至国家或国际标准？例如：美国的NIST
5Is equipment identified with a suitable indicator that indicates calibration status?确定一个合适的指标，以表明校准设备的状态？
a. Are items requiring only a functional check identified as calibration not required? 项目只需要作功能检查时是否确定为不要求校准？
白玉菇的做法b. Does calibration identification include date of last calibration?校准标识上是否包含上次校准日期
c. Does calibration identification include by whom it was calibrated?校准标识上是否包含校准者
d. Does calibration identification include next calibration due date? 校准标识上是否包含下次校准日期
6Are calibration records maintained? 校准记录是否保存？
7Does the procedure describe remedial action when accuracy or precision limits are not met?当准确度或精度的限制不符合时，过程描述是否采取补救措施？
空穴来风造句8Are there written procedures in place to asss the validity of previous test results when equipment is found to be out calibration?当设备被发现未校准，是否有制定书面程序，以评估先前使用时的测试结果有效性？9Are the environmental conditions for calibrations and measurements suitable?合适的校准和测量的环境条件？#Is proper handling, prervation, and storage ud to ensure calibration integrity?有无确保合理的的搬动、妥善处理，保存，存储的要求？
#Is the equipment safeguarded against adjustments that would invalidate the calibration by non qualified personnal?由无资格人员进行的设备调整校准是否有效？
#Is calibration frequency determined and adjusted bad on required accuracy, stability, purpo an
d degree of u?有无确定校准频率和调整基础上所要求的精度，稳定性，目的和利用程度？
#Is software or comparative references ud for inspection verified and rechecked at prescribed intervals to assure
capability of verifying the acceptability of the product?软件或用于检查核实，并在规定的时间间隔复查，比较参考以确保核实产品的可接受性的能力？
1Is there a documented procedure for identifying the inspection and test status of all products (conforming and
nonconforming, raw materials, in-process and final products)? 是否有文件规定，确定所有产品的检验和测试状态（不合格和不合格的原材料，在过程和最终产品）？
2Is product status maintained throughout production, installation, and rvicing?产品状态是否有效存在整个生产，安装和维修保养的产品？
1Are there documented procedures for the control of nonconforming product? Do they provide for: 是否有不合格品的控制文件的程序？是否包含提供
K. Inspection & Test Status 检验测试状态
L. Nonconforming Product / Produit non conforme 不合格品
a. Identification鉴定
b. Documentation存档
c. Evaluation评估
d. Segregation隔离
e. Disposition特征
f. Investigation调查
g. Notification to customer通知客户
2Is the responsibility for review and disposition defined? 是否定义审查和处置的责任？
3Is justification for any concessions to u nonconforming material documented?任何让步使用不合格的材料的记载
及理由
4Are there procedures for rework, identification for reworked product, and reinrtion and effect of reworking?是否有返工，返工后的产品鉴定，安置和改造效果的程序？
M. Corrective and Preventive Action 纠正和预防行动
红色宣传画1Are there documented procedures for implementing corrective and preventive action? Do they include：是否有书面程序，实施纠正和预防措施吗？它们包括
a. Analyzing sources of quality data (including work operations, concessions, trending data, quality audit reports, rvice records, complaints/mdrs, returned product, other sources of quality data) 分析质量数据源（包括工作业务，让步，趋势数据，质量审核报告，服务记录，投诉/ MDRS，退回的产品，其他来源的数据质量）
b. Investigating cau and recording results调查原因，并记录结果
c. Determine corrective action needed确定需要纠正行动
d. Verify propod corrective action as part of engineering change review纠正措施作为工程变更审查部分进行验
证
e. Evaluate for implementation and effectiveness of corrective action.纠正行动的实施和成效评估。
f. Disminate related information to appropriate persons以适当的人传播有关信息
海的女儿读后感20字g. Submit results for management review提交管理评审结果贪的成语
2Is action commensurate with the risk and magnitude of the problem?行动的风险和问题的严重性相称吗？
3Are procedural changes resulting from corrective/preventive action implemented and recorded?实施的程序的变化是否参照纠正/预防措施记录？
4Are complaint files maintained?投诉文件保持吗？
5Is there a documented procedure for receiving, reviewing, and evaluating complaints? Does it ensure: 是否有文件程序规定的受理，审查和评价投诉？是否确保：
a. All complaints are procesd in a uniform and timely manner 所有投诉都获得统一及时处理
b. Oral complaints are documented upon receipt 收到口头投诉也做记录
c. Complaints are evaluated to determine whether the complaint reprents an event requiring reporting to the FDA 投诉
进行评估，以确定投诉是否代表需要向FDA报告的事件
6Are complaints handled by a formally designated unit?由正式指定单位处理投诉？
7Are complaints reviewed and evaluated to determine the need for investigation?审查和评估，以确定需要调查的投
诉？
8Are records maintained (for investigations or why investigations were not required) ?保持调查内容及原因的记录
吗？
9Are complaints which involve the possible failure of the device, labeling, or packaging to meet any of its specifications reviewed, evaluated or investigated?评估或调查的任何投诉是否涉及可能出现的故障设备，标签或包装，以
满足其规格审查
#Are complaint files reportable to the FDA maintained in a parate file or are specially identified?报告给FDA的投诉文件单独保存或专门鉴定？
#Are complaints trended?投诉的趋势？
