1、全套FDA内部质量审核检查表ISO13485QSR820共52页全套FDA内部质量审核检查表(ISO13485&QSR820)内部质量审核检查表-投诉、不良事件报告、纠正和预防措施及召回部分INTERNAL QUALITY AUDIT CHECKLIST- Part: Complaints, AERs, CAPA & Recalls 被审核部门 Auditee: _日期Date: _ 适用法规（Applicable regulation）: ISO 13485/9001 8.1、8.2.1、8.4、8.5.1、8.5.2、8.5.3 /China GMP 66、71-76, / FDA 820
2、.40、820.198、820.100/ Japan MHLW Ordinance No. 169编号No.问题QuestionY or N or N/A意见与客观依据Comments & Objective Evidence1Is the procedure established for receiving, reviewing and evaluating complaints?Is there a formally designated unit and/or persons who perform this function in accordance with the proced
3、ure?Were all complaints processed in a uniform and timely manner? 是否建立了投诉的接收，审评和评估的程序文件？是否有指定的团体或人员按照程序进行投诉处理？投诉的处理方式是否统一且及时？ 2Are oral complaints documented upon receipt?Dose all the complaints have fully documented investigations and determine the major cause of complaint? Or is there a record of
4、the reason no investigation was made? If the products returned from customers are identified and disposed appropriately？ If the linkage is defined with corrective action? If any customer complaint was not followed by corrective and/or preventive action, is the reason authorized and recorded?口头抱怨在收到时
5、是否形成文件？是否所有投诉都进行了调查并确定投诉的主要原因，或对不需进行调查的原因进行记录？ 是否识别、处置顾客返回的产品？ 是否规定了转入纠正措施的路径？如果没有针对投诉采取纠正和/或预防措施，是否进行了批准并记录原因？3Whether procedure is established and documented on analysis and study of the implantable MD taken out from human body. When got the used implantable medical devices, whether manufacturer d
6、oes analysis and study of it, and collect information about product efficacy and safety to improve product quality and safety.是否制定了对取出的植入性医疗器械进行分析研究的规定并形成文件，在获得取出的植入性医疗器械时，是否对其分析研究，了解植入产品有效性和安全性方面的信息，用于提高产品质量和改进产品的安全性。 4Do all the records of complaint investigations include: (1) the name of the devi
7、ce; (2) the date the complaint was received; (3) any device identification and control number(s); and (4) the name, address, and phone number of the complainant? (5) the nature and details of the complaint; (6) the dates and results of the investigation; (7) any corrective action taken; and (8) any
8、reply to the complainant?投诉记录调查文档是否包括以下内容：(1)器械名称；（2）接到投诉的日期；（3）器械标识和控制编号；（4）投诉人的姓名，地址和电话号码；（5）投诉的性质和详细细节；（6）调查的日期和结果；（7）采取的任何纠正措施；（8）对投诉人的任何答复。5If investigation determines that activities outside of the organization contributed to a customer complaint, is there a process to exchange relevant inform
9、ation between the organizations involved?如果调查结果确定是由于组织外的活动导致了投诉问题，是否相关资料在所涉及的组织间传递？6Is the procedure for MDR established?Whether its specified of potential adverse event personnels responsibility, reporting principle, reporting process, and reporting timeline? Whether procedure and document are prep
10、ared on initiation of medical device re-evaluation, and comply with regulatory requirements?是否建立了不良事件报告的程序？是否规定了可疑不良事件管理人员的职责、报告原则、上报程序、上报时限，制定了启动实施医疗器械再评价的程序和文件等，并符合法规要求。 7Do documented procedure(s) require that Complaints be evaluated for possible MDR to appropriate authorities? Is there evidence
11、these procedure(s) are being followed, and necessary reports have been submitted within required time limits with records?程序文件是否要求对投诉进行不良事件报告评估，并向相应的政府部门报告？是否有证据证明需要进行报告的事件已经按照程序在规定的时限内上报，并有记录？8Have all complaints related to a reportable MDR event been promptly reviewed, evaluated, and investigated
12、by designated individuals, and are these files separated or otherwise clearly identified from the other complaint files?是否所有涉及可汇报不良事件汇报的投诉被指定人员及时审评，评估和调查？是否单独保存或与其他投诉相比有明显的识别标识？9In addition to the information required by above item 4, if records of investigation related to a reportable MDR event doc
13、ument include a determination of: (1) whether the device failed to meet specifications? (2) the relationship, if any, of the device to the reported incident or adverse event?除以上第4条要求的内容外，是否所有涉及可汇报不良事件汇报的投诉调查文档包括了：（1）该器械是否符合产品规范?（2）该器械与报告的事件或不良反应之间是否有任何联系？ 10Whether the monitoring and re-evaluation o
14、f adverse events are implemented as per procedure and relevant regulations, and the record kept available?是否按照程序文件和相关法规的规定，开展了不良事件监测和再评价工作，并且记录和归档？ 11Are the procedure(s) established and maintained for implementing corrective and preventative action?是否建立和保持实施纠正和预防措施的程序？12Are the input sources for th
15、e Corrective Action system defined in procedure? Shall include but not limited to below items: Processes data, work operations data, concessions, quality audit reports (internal & external), quality records, complaints, returned product, and other sources of quality data to identify existing and pot
16、ential causes of nonconforming product, or other quality problems.程序中是否定义纠正措施系统信息源输入？确认包括以下信息源，但不限于：过程数据，工序操作数据，让步接受的数据记录，质量审核报告（内外部），质量数据，客户投诉，返回产品，识别已存在的和潜在的产品不符合，或其他质量问题。13If is there a requirement for investigating the cause of nonconformities relating to product, processes and the quality syste
17、m in procedure? Review the suitability of investigation and confirm the documented records are in place.程序是否要求对导致相关的产品，过程和质量体系不合格的根本原因进行调查？评审调查的适合性，并确认有记录。 14If the action(s) needed to correct and/or prevent recurrence of nonconforming product and other quality problems is identified? If no action n
18、eeded, the reasonable rational is in place and approved? Record available?是否定义了可以纠正和/或预防产品和其他质量不合格再次发生的措施？如无措施计划，是否有合理的理由并得到批准？记录是否存在？15If the corrective and preventive action is verified or validated to ensure that such action is effective and dose not adversely affect the finished device?if the in
19、formation related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problem? If the documented records is in place and available?纠正和预防措施是否被确认或验证有效且不会对最终产品有负面影响？ 与质量问题或不合格产品相关信息是否传达到直接相关的人员？文件记
20、录存在并可获取。16If all corrective and/or preventive the actions are implemented according to plan?If the documented records is in place and available?纠正预防措施的实施状态是否与计划一致？文件记录存在并可获取。17If appropriate statistical methodology be employed for monitoring on issue recurrence? Check CAPAs history and verify no unr
21、easonable recurrence.是否使用了合适的统计方法对问题的重复发生进行监测？ 检查纠正预防措施历史记录，确认无不合适的重复发生。18Whether procedure for drafting, approving and issuing advisory notice is established and documented？Whether procedures are prepared for advisory notice issuance and actions, like recall, taken on medical devices with potential
22、 safety issue, and whether these procedures meet the regulatory requirement？Is there evidence of compliance?是否建立了关于起草、批准和发布忠告性通知的程序并形成文件？ 是否制定了发布忠告性通知和对于存在安全隐患的医疗器械采取召回等措施的程序文件，并符合相关法规的要求？ 是否按程序实施并保存记录？ 19Sample field actions and related records to determine whether the appropriate analysis, plan an
23、d execution were accomplished to ensure that:Customer was notified within a reasonable time frame?Defective lots were disposed appropriately? Possible defective lots were appropriately inspected and disposed?若有市场措施，是否进行适当的分析，计划和执行，以确保：客户在合理的时间内得到通知？有缺陷的批次被适当处置？潜在的有缺陷的批次得到合适的检查和处置？20Was the necessary
24、 reporting of a field action reported to the government surveillance department following the procedure and documented?市场措施是否按照程序要求向政府监督部门进行报告并且有记录？21Follow up with the findings of previous internal audits related to this part上次内审与此部分相关发现项的追踪审核发现/观察项/其他：Audit finding/Observations/Others审核员签名 /日期 Aud
25、itor Signature(s)/Date: 内部质量审核检验表-文件和记录控制, 电子记录和签名internal Quality Audit Checklist: Document and Record Control，Electronic record and signature被审核部门Auditees: _ 日期Date: _适用法规（Applicable regulation）: ISO 13485/9001 4.2.1、4.2.3、4.2.4 、7.1 / China GMP 24、25、26、27/ FDA 820.40、820.180、820.181、820.186 / 21
26、 CFR 11/Japan MHLW Ordinance No. 169编号No.问题QuestionY or N or N/A意见与客观依据Comments & Objective Evidence文件和记录控制Document and Record Control1.Is there a documented procedure in place that describes approval, distribution, and change control for QMS procedures and other controlled documents?是否有文件化的程序定义了QMS
27、程序和其他受控文件的批准、发放和变更控制要求？2.Is there a documented procedure defining retention and storage periods for documents, including obsolete or superseded documents? Is there evidence the procedure is implemented and followed?是否有文件化的程序定义文件的保存期限？ 包括废止文件或旧版文件？是否有证据证明程序有效实施？ 3.Has the organization ensured that ch
28、anges to documents are reviewed and approved either by the original approving function or by another designated function that has access to pertinent background information upon which to base its decisions?当文件变更时，是否由初始评审和批准部门或对决定有相关背景信息的指定人或部门进行评审和批准？4Is the procedure defined the re-approval period
29、for the documents havent been updated within a period? And evidence available for re-approval?是否有程序定义对一段时期内未更新文件需重新评？5Are the appropriate documents available at all locations for which they are designated, used, or otherwise necessary?是否在指定的、需使用或必要的场所可获得适用文件的有效版本？6Were all obsolete documents removed
30、 or otherwise prevented from unintended use?作废文件是否撒离或其他方法以防止非预期使用？7Were approved changes or issuance of new procedures communicated to the appropriate personnel in a timely manner?新程序或变化的程序是否及时地与适当人员进行沟通？8Are change records for documents maintained, and do they include: a description of the change;
31、signature of approving individual(s); approval date; and effectivity date?文件的变化记录是否保持？ 包括变化的描述、批准人的签字、批准日期和文件生效日期？9Are mechanisms defined to ensure that any documents of external origin are identified, controlled, and reviewed for continued applicability? If required, are revisions to such documents communicated as appropriate?是否有机制以保证识别、控制和评审外部文件适用性？适用时，文件的相关版本是否进行沟通？10Whether manufacturer assign special person or department to collect related l
