Risk-Management-Report

1、FRND-SOP-002-01-03 Page 1 of 16 / FRND-SOP-002-01-03 第 1 页共 16 页XXXX公司FORM表格Document No.文件号:FRND-SOP-002-01-03RISK MANAGEMENT ANALYSISEVALUATIONREPORT风险管理分析、评价、才艮告Effective Date 生效日期：2011-07-28Page页码：Page 1 of 16文档编号Finalization Date 定稿日期：口 Analysis and Evaluation口 ReportAssignment of Responsibility

2、 职责分工Position 职务：Signature 签名：Date日期:Draw Up编制人：Project Leader 项目 负责人:Participator 参与人：Risk management team风险管理团队Name姓名Assignment of responsibility职责和权限Product instruction 产品介绍Product name 产品名称Product model or code产品型号或物料代码Intended use预期用途Main structure 主要结构Main materials 主要材料Work environment 使用环境Ri

3、sk evaluation criteria风险评价准则（参考）FRND-SOP-002-01-03 Page 2 of 16 / FRND-SOP-002-01-03 第 2 页共 16 页Risk Management Analysis EvaluationReportNo序号Questions Description 问题描述Identify 判定Conclusion Description 结论描述Table 1 Example of five qualitative severity levels 表 1-严重度 5 级举类Severity 严重度Criteria descripti

4、on标准描述Ranking 等级Catastrophic 灾难性的Results in patient death 导致患者死亡5Severe危重的Results in permanent impairment or life-threatening injury 导致永久型损伤或危及生命的伤害4Critical严重Results in injury or impairment requiring professional medical intervention导致要求专业医疗介入的伤害或损伤3Marginal 轻度Results in temporary injury or impairm

5、ent not requiring professional medical intervention导致不要求专业医疗介入的暂时伤害或损伤2Negligible 可忽略Inconvenience or temporary discomfort 不方便或暂时不适1Table 2 Example of semi-quantitative probability levels 表 2 4既率 6 级示类Probability levels 可能性Criteria description 标准描小Ranking 等级Frequent 经常>10-16Probable有时>10-25Occ

6、asional偶然<10-2and > 10-34Rare很少< 10-3and > 10-43Remote 非常少<10-4and > 10-62Improbable 极少<10-61Table 3 Detection Classifications 表 3 探测度 5 级示类Detection levels 探测度Criteria description标准描述Ranking 等级Almost Certain几乎确定Almost certainly detect a potential cause/mechanism and subsequent

7、failure mode 几乎确定可探测到潜在失效原因/机理和引发的失效模式1No序号Questions Description 问题描述Identify 判定Conclusion Description 结论描述Risk Management Analysis EvaluationReportFRND-SOP-002-01-03 Page 3 of 16 / FRND-SOP-002-01-03 第 3 页共 16 页Risk Acceptable description 风险接受描述Key 图类Unacceptable risk不可接受风险Need to take action需采取措施降

8、低风险Acceptable risk可忽略的风险RPN=严重度X发生可能性X探测度（RPN >12 &严重度3 &发生可能性4）必须采取措施High 高High chance detect a potential cause/mechanism and subsequent failure mode 后高的可能性探测到潜在失效原因/机理和引发的失效模式2Moderate中等Moderate chance detect a potential cause/mechanism and subsequent failure mode 有中等的可能性探测到潜在失效原因/机理和引发

9、的失效模式3Low 低Low chance detect a potential cause/mechanism and subsequent failure mode 有低可能性探测到潜在失效原因/机理和引发的失效模式4Remote极小Remote chance l detect a potential cause/mechanism and subsequent failure mode 有极小的可能性探测到潜在失效原因/机理和引发的失效模式5Table 4 Risk Matrix 表 4风险矩阵Accept rankingSeverity levels 严重度Negligible 可忽略

10、Marginal 轻度Critical 严重Severe危重的Catastrophic 灾难性的Probability levels 可能性Frequent 经常612182430Probable有时510'152025Occasional偶然48121620Rare很少3691215Remote 非常少246810Improbable 极少12345FRND-SOP-002-01-03 Page 4 of 16 / FRND-SOP-002-01-03 第 4 页共 16 页四 Questions list to device characteristics器械特性问题清单：(Acc

11、. to EN ISO 14971:2009, Annex C)No序号Questions Description 问题描述Identify 判定Conclusion Description 结论描述1What is the intended use and how is the medical device to be used?什么是预期用途/预期目的和怎样使用医疔器械？2Is the medical device intended to be implanted? 医疔器械是否预期植入？3Is the medical device intended to be in contact wi

12、th the patient or other persons?医疔器械是否预期和患者或其他人员接触？4What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?在医疗器械中利用何种材料或组分，或与医疔器械共同使用或与 其接触？5Is energy delivered to or extracted from the patient? 是否有能量给予患者或从患者身上获取?6Are substances d

13、elivered to or extracted from the patient? 是否有物质提供给患者或从患者身上提取？7Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?医疔器械是否处理生物材料用于随后的再次使用、输液/血或移植？8Is the medical device supplied sterile or intended to be sterilized by the user, or are other m

14、icrobiological controls applicable? 医疔器械是否以无菌形式提供或预期由使用者灭菌，或用其它微 生物学控制方法火菌？9Is the medical device intended to be routinely cleaned and disinfected by the user?医疔器械是否预期由用户进行常规清洁和消毒?10Is the medical device intended to modify the patient environment?医疔器械是否预期改善患者的环境？11Are measurements taken?是否进行测量？12Is

15、the medical device interpretative?医疔器械是否进行分析处理？No序号Questions Description 问题描述Identify 判定Conclusion Description 结论描述Risk Management Analysis EvaluationReportFRND-SOP-002-01-03 Page 5 of 16 / FRND-SOP-002-01-03 第 5 页共 16 页13Is the medical device intended for use in conjunction with other medical devic

16、es, medicines or other medical technologies?医疔器械是否预期和其它医疔器械、医药或其它医疗技术联合使 用？14Are there unwanted outputs of energy or substances? 是否后不希望的能量或物质输出？15Is the medical device susceptible to environmental influences? 医疔器械是否对环境影响敏感？16Does the medical device influence the environment?医疔器械是否影响环境？17Are there es

17、sential consumables or accessories associated with the medical device?医疔器械是否有基本的消耗品或附件？18Is maintenance or calibration necessary? 是否需要维护和校准？19Does the medical device contain software?医疔器械是否有软件？20Does the medical device have a restricted shelf-life? 医疔器械是否有储存寿命限制？21Are there any delayed or long-term

18、use effects? 是否有延时或长期使用效应？22To what mechanical forces will the medical device be subjected? 医疔器械承受何种机械力？23What determines the lifetime of the medical device?什么决定医疔器械的寿命？24Is the medical device intended for single use? 医疔器械是否预期一次性使用？25Is safe decommissioning or disposal of the medical device necessar

19、y?医疗器械是否需要安全地退出运行或处置？26Does installation or use of the medical device require special training or special skills?医疔器械的安装或使用是否要求专门的培训或专门的技能？27How will information for safe use be provided? 如何提供安全使用信息？No序号Questions Description 问题描述Identify 判定Conclusion Description 结论描述Risk Management Analysis Evaluati

20、onReportFRND-SOP-002-01-03 Page 6 of 16 / FRND-SOP-002-01-03 第 6 页共 16 页28Will new manufacturing processes need to be established or introduced?是否需要建立或引入新的制造过程？29Is successful application of the medical device criticallydependent on human factors such as the user interface?医疔奋械的成功使用，是否关键取决于人为因素，例如用户

21、界面？29.1Can the user interface design features contribute to use error?用户界面设计特性是否可能促成使用错误？29.2Is the medical device used in an environment where distractions can cause use error?医疔器械是否在因分散注意力而导致使用错误的环境中使用？29.3Does the medical device have connecting parts or accessories? 医疔器械是否有连接部分或附件？29.4Does the me

22、dical device have a control interface?医疗器械是否有控制接口？29.5Does the medical device display information? 医疔器械是否显示信息？29.6Is the medical device controlled by a menu? 医疔器械是否由菜单控制？29.7Will the medical device be used by persons with special needs? 医疔器械是否由具有特殊需要的人使用？29.8Can the user interface be used to initiat

23、e user actions?用户界面能否用于启动使用者动作？30Does the medical device use an alarm system? 医疔器械是否使用报警系统？31In what way(s) might the medical device be deliberately misused?医疔器械可能以什么方式被故意地误用？32Does the medical device hold data critical to patient care? 医疗器械是否持有患者护理的关键数据？33Is the medical device intended to be mobile

24、 or portable?医械是否预期为移动式或便携式？34Does the use of the medical device depend on essential performance?医疔器械的使用是否依赖于基本性能？FRND-SOP-002-01-03 Page 7 of 16 / FRND-SOP-002-01-03 第 7 页共 16 页五 Hazards, foreseeable sequences of events and hazardous situations AnalysisEvaluationControl危害 可预见的事件 危害处境 分析评价 控制：(Acc.

25、to ENISO 14971:2009, Annex E)缩略词：Abbreviations usedRE风险评估 Risk EvaluationS严重性SeverityO发生频率OccurrenceD发现程度DetectionRPN风险优先指数 Risk Priority Number = 严重性 Severity发生频率 Occurrence侬现程度 DetectionRRM风险减少措施 Risk Reduction MeasureNH新危害发生 New hazard generated (no/ yes - if yes,如不可接受，写出危害号码then number of new ha

26、zard indicated)ALOR风险是否可接受 Acceptable Level of Risk (no/ yes)No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 8 of 16 / FRND-SOP-002-01-03 第 8 页共 16 页Risk Management Analysis EvaluationReportE.1 Energy Haza

27、rds 能量危害1Line voltage 网电源/2Leakage current 漏电流/3Electric fields 电场/4Magnetic fields 磁场/5Ionizing radiation 电离 辐射/6Non-ionizing radiation 非电离辐射/7High temperature 高 温/8Low temperature 彳氐温/9Gravity falling 坠落/10Suspended masses 悬挂物/11Vibration 振动/12贮存的能量Stored energy/13Moving parts运动零件/14Torsion, shear

28、 and tensile force 扭转力、剪切力和张力/15Moving and positioning of patient 患者的移动和定位/16Ultrasonic energy 超 声能量/17Infrasound energy 次 声能量/18Sound声音/19High pressure fluidinjection高压液体注射/E.2 Biological and Chemical Hazards生物和化学危害1.Bacteria. JSM./_/._/_1/,/No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Me

29、asure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 9 of 16 / FRND-SOP-002-01-03 第 9 页共 16 页Risk Management Analysis EvaluationReport2-Viruses 病毒/"/"/3Other agents (e.g. prions)其他介质/4Re- or cross-infection再次或交叉感染/5Acids or alkalis 酸或 碱/6Residues残留物/7Contam

30、inates 污染物/809additives or processing aids 添力口剂或加工助剂cleaning, disinfectingor testing agent清洁剂、消毒剂或试验试剂/111 /10Degradation products 降解产物/11medical gasses 医用 气体/12Anaesthetic products 麻醉产品/13Toxicity of chemicalConstituents 化学毒性/14生物不相容Bioincompatibility/15allergenicity 变态反应性/16irritancy 刺激/17pyrogeni

31、city 致热原/E.3 Environmental hazards and contributory factors环境危害及其形成因素1电能 electricity/2Pressure 压力/3辐射 radiation/4音量volume/5Susceptibility to electromagnetic interference 对电磁干/No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-S

32、OP-002-01-03 Page 10 of 16 / FRND-SOP-002-01-03第 10 页共 16 页Risk Management Analysis EvaluationReportll忧的敏感性6Emissions of electromagnetic interference 电磁干扰 的发射/7供 Inadequate supply of power不充足的能 量提/8inadequate supply of coolant不充京的冷却提供/9Storage or operation outside prescribed environmental conditions

33、 储存或操作 偏离规定的外部环境 条件/10Incompatibility with other devices 与其它器械不相容/11Accidental mechanical damage 意外的机械危害/12corrosions 腐蚀/13degradation,降解/14contamination 污染/E.4. Hazards related to theuse of the device and contributory factors使用器械危害及其形成因素1Inadequate labeling 不充分的标签/2Inadequate operating instructions

34、 不适当的 使用手册如：? inadequate specification of accessories 附件技 术规范不适当? inadequate specification of preuse checks 预期使 用检查规范不适当/No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 11 of 16 / FRND-SOP-002-01-03第 11 页共

35、 16 页Risk Management Analysis EvaluationReportl? -over-complicaed operating instructions 操作说 明书过于复杂? inadequate specification of service and maintenance 服务 和维修规范不适当3Use by unskilled/untrained personnel 由无经验或 未经培训的人使用/4Reasonably foreseeable misuse 合理的可预见的错误 使用/5Insufficient warning of side effects不充

36、分的 副作用警告/6Inadequate warning of hazards likely with re-use of single use devices不充分的一次 性使用器械重复使用 后的可能危害/7Incorrect measurement and other metrological aspects不正确的测量 和其它方面计量/8Incompatibility with consumables/accesso ries/other devices 与 消耗品/附彳/其它器械 不相容/9sharp edges or points 锐边、锐角/E.5 Inappropriate, i

37、nadequate or over-complicated user interface (man/machine communication)/、止确、/、充分或过于复杂的用户介面(人/机交流)1Jt送或判断错送工/./No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 12 of 16 / FRND-SOP-002-01-03第 12 页共 16 页Risk

38、Management Analysis EvaluationReportMistakes and judgement errors-2r重叠而认知检索错误Lapses and cognitive recall errors/3Attentional failure 缺乏 注意力/4违反或偏离说明书、 程序等 Violation orabbreviation of instructions, procedures, etc.,/5复杂或混淆的控制系统 Complex or confusing control system/6含糊的或不清晰的医 疗器械状态Ambiguous or unclear

39、device state/7设置、测量或其它信 息的含糊或不清晰的 显示 Ambiguous or unclear presentation of settings, measurements or other information/8结果的错误显示Mispresentation of results/9视觉、听觉或触觉的 不充分 Insufficient visibility, audibility or tactility/10 !动作控制或实际状态 “言息显示的图象不清 :Poor mapping of controls to action, or ；of displayed1 inf

40、ormation to actual s state/No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 13 of 16 / FRND-SOP-002-01-03第 13 页共 16 页Risk Management Analysis EvaluationReport11写顼荐凌备布区祈” 式或图象成问题Controversial modes or mappin

41、gs as compared to existing equipmentT/"/"/E.6. Hazards arising from functional failure, maintenance and ageing功能性失效，维护、老化的危害和形成因素1错误的数据转换 Erroneous data transfer/2维护（包括维修后功 能检查技术参数不 足）的技术参数不足 或缺乏 Lack of , or inadequate specification for maintenance including inadequate specification of po

42、st maintenance functional checks/3不适当的维护Inadequate maintenance/4缺之决7E器械寿命 的因素决定Lack ofadequate determination of end of device life/5缺少电气/机械完整 性 Loss of electrical / mechanical integrity/6不值当的包装（污染和/或器械损坏）InadequateL.packaging（contam.i.n./No.序 号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure

43、证明 EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLFRND-SOP-002-01-03 Page 14 of 16 / FRND-SOP-002-01-03第 14 页共 16 页Risk Management Analysis EvaluationReportation and /or deterioration of the device )7,重复使用或不正确 的重复使用 re-use and / or Improper re-use/8由于重复使用造成 的功能恶化(如液/ 气路的逐渐闭塞、 流阻、电导率的变 化)Deterioration in function (e.g.gradual occlusion of fluid/gas path, or change in resistance to flow, electrical conductivity) as a result of repeated use./E.7 Production and post-pro