醫(yī)療器械質(zhì)量體系QR-QP-17-02 風(fēng)險(xiǎn)管理報(bào)告

1、 DOCPROPERTY 文件編號(hào) * MERGEFORMAT 錯(cuò)誤！未知的文檔屬性名稱（ DOCPROPERTY 版本 * MERGEFORMAT 錯(cuò)誤！未知的文檔屬性名稱）第 Document name:Risk management reportWritten: Auditor: Approved: Date:Date:Date:Revision RecordVer.Revision descriptionReviserDateTable of Contents TOC o 1-3 h z HYPERLINK l _Toc375898757 Table of Contents PAGER

2、EF _Toc375898757 h 2 HYPERLINK l _Toc375898758 Chapter1 Summary PAGEREF _Toc375898758 h 3 HYPERLINK l _Toc375898759 Chapter2 Risk Analysis Participants PAGEREF _Toc375898759 h 4 HYPERLINK l _Toc375898760 Chapter3 General Introduction PAGEREF _Toc375898760 h 5 HYPERLINK l _Toc375898761 3.1Category PA

3、GEREF _Toc375898761 h 5 HYPERLINK l _Toc375898762 3.2Product Overview PAGEREF _Toc375898762 h 5 HYPERLINK l _Toc375898763 3.3Intended Use PAGEREF _Toc375898763 h 5 HYPERLINK l _Toc375898764 3.4Composition PAGEREF _Toc375898764 h 5 HYPERLINK l _Toc375898765 3.5Relative standard PAGEREF _Toc375898765

4、h 5 HYPERLINK l _Toc375898766 Chapter4 Judgment of Characteristics Rate to Safety PAGEREF _Toc375898766 h 6 HYPERLINK l _Toc375898767 Chapter5 Summarization of the Risk Management PAGEREF _Toc375898767 h 10 HYPERLINK l _Toc375898768 Chapter6 Information of Production and Post-Production PAGEREF _Toc

5、375898768 h 12 HYPERLINK l _Toc375898769 Chapter7 Completeness Evaluation of Risk PAGEREF _Toc375898769 h 13 HYPERLINK l _Toc375898770 Chapter8 Evaluation of Residual Risk PAGEREF _Toc375898770 h 14 HYPERLINK l _Toc375898771 Chapter9 Information updating and risk management after manufacturing PAGER

6、EF _Toc375898771 h 15 HYPERLINK l _Toc375898772 Appendix A. Analysis method PAGEREF _Toc375898772 h 16 HYPERLINK l _Toc375898773 A.1Harm analysis method PAGEREF _Toc375898773 h 16 HYPERLINK l _Toc375898774 A.2Risk estimate method PAGEREF _Toc375898774 h 16 HYPERLINK l _Toc375898775 Appendix B. Analy

7、sis Method PAGEREF _Toc375898775 h 17 HYPERLINK l _Toc375898776 B.1. Estimation of the severity of each hazard PAGEREF _Toc375898776 h 17 HYPERLINK l _Toc375898777 B.2. Estimation of the likelihood of each hazard PAGEREF _Toc375898777 h 18 HYPERLINK l _Toc375898778 B.3. Estimation of the acceptabili

8、ty of each risk PAGEREF _Toc375898778 h 19 HYPERLINK l _Toc375898779 Appendix C Abbreviations used PAGEREF _Toc375898779 h 20 HYPERLINK l _Toc375898780 Appendix D Contents of Tables PAGEREF _Toc375898780 h 21SummaryStandard informationStandardISO14971: 2007NameMedical devices - Application of risk m

9、anagement to medical devicesTest product informationNameModelConclusionFail itemRemarkRisk Analysis ParticipantsMemberDepartmentPositionResponsibilitySignatureDirectorResearch and development departmentTechnology managerBe responsible for planning, approval and application of risk management report.

10、-MemberResearch and development departmentManagerAnticipate the activities of planning, writing, evaluation and application of risk management report.Research and development departmentEngineerProvide information and experiences from the viewpoint of technology;Anticipate the activities of risk anal

11、ysis and review;Review the activities of risk management；Provide risk control methods in the viewpoint of technology.Manufacture departmentManagerProvide information and experiences from the viewpoint of manufacturing;Anticipate the activities of risk analysis and review;Review the activities of ris

12、k management;Provide risk control methods in the viewpoint of manufacturing.Market departmentManagerProvide information and experiences from the viewpoint of product control, sale and after sale service;Anticipate the activities of risk analysis and review;Review the activities of risk management;Pr

13、ovide risk control methods in the viewpoint of product control, sale and after sale service.Quality departmentQuality directorAnticipate the activities of risk analysis and review;Verification the effect of risk management methods.Quality departmentTest operator(When necessary) test product.General

14、IntroductionCategoryThis document is established according to standard ISO14971:2007-the risk management for medical devices. The goal is to systematically carry out the effective management of the various risk processes for the companys R&D and manufacture of XXXXX The document is the instructive d

15、irection for design, confirmation, production and sales, and for CE authentication, FDA authentication and SFDA authentication constituent.Product OverviewIntended UseCompositionRelative standardStandard TypeNumberNameNoteRisk ManagementISO14971:2007Medical devices - Application of risk management t

16、o medical devicesCENUSABio-compatibilityEN ISO10993-1:2009Biological evaluation of medical devices - Part1: Evaluation and testingCENSafetyIEC 60601-1:2005Medical electrical equipment - Part1: General requirements for basic safety and essential performanceCENEN 12470-4:2000+ A1:2009Clinical thermome

17、ters - Part 4: Performance of electrical thermometers for continuous measurementCENEMCEN 60601-1-2:2007Medical equipment - Part1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and testsCENUsabilityIEC60601-1-6:2006Medical electrical equipment Part

18、1-6:General requirements for basic safety and essential performance Collateral Standard: UsabilityCENLabelEN 980:2008Graphical symbols for use in the labeling of medical devicesCENJudgment of Characteristics Rate to SafetyTable SEQ 表 * ARABIC 1 Qualitative and quantitative analysis of the characteri

19、sticsNoSafety-related characteristics that could have impact on safetyYes/NoSafety-related characteristics identification1What is the intended use and how is the medical device to be used?2Is the medical device intended to be implanted?3Is the medical device intended to contact the patient or other

20、persons?4What materials or components are incorporated in the medical device or are used with, or are in contact with, the medical device?5Is energy delivered to or extracted from the patient?6Are substances delivered to or extracted from the patient?7Are biological materials processed by the medica

21、l device for subsequent re-use, transfusion or transplantation?8Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?9Is the medical device intended to be routinely cleaned or disinfected by the user?10Is the medical device

22、 intended to modify the patient environment?11Are measurements taken?12Is the medical device interpretative?13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?14Are there unwanted outputs of energy or substances?15Is the medica

23、l device susceptible to environmental influences?16Does the medical device influence the environment?17Are there essential consumables or accessories associated with the medical device?18Is maintenance or calibration necessary?19Does the medical device contain software?20Does the medical device have

24、 a restricted shelf-life?21Are there any delayed or long-term use effects?e.g., ergonomics and accumulative effects.22To what mechanical forces will the medical device be subjected?23What determines the lifetime of the medical device?24Is the medical device intended for single use?25Is safe decommis

25、sioning or disposal of the medical device necessary?26Does installation or use of the medical device require special training?27How will information for safe use be provided?28Will new manufacturing processes need to be established or introduced?29Is successful application of the medical device crit

26、ically dependent on human factors such as the user interface?29.1Can the user interface design features contribute to use error?29.2Is the medical device used in an environment where distractions can cause use error?29.3Does the medical device have connecting parts or accessories?29.4Does the medica

27、l device have a control interface?29.5Does the medical device display information?29.6Is the medical device controlled by a menu?29.7Will the medical device be used by persons with special needs?29.8Can the user interface be used to initiate user actions?30Does the medical device use an alarm system

28、?31In what way(s) might the medical device be deliberately misused?32Does the medical device hold data critical to patient care?33Is the medical device intended to be mobile or portable?34Does the use of the medical device depend on essential performance?Summarization of the Risk ManagementTable SEQ

29、 表 * ARABIC 2 Summarization of the Risk ManagementItemPotential HazardsS(F/B)L（F/B）R（F/B）Risk Reduction MeasureVerificationCompanion new hazardALOR1Energy hazards1.12Biological hazards2.13Environmental hazards3.14.Incorrect outputs of energy and materials (NA)5.Hazards related to the use of the medi

30、cal device5.16Hazards arising from inadequate, inappropriate or over-complex user interfaces (human/machine communication)6.17Hazards arising from functional lack, maintenance failure and ageing7.18Inaccurate output data8.1Information of Production and Post-ProductionItemInformation of Production an

31、d Post-ProductionS(F/B)L（F/B）R（F/B）MeasureVerificationCompanion new hazardALORCompleteness Evaluation of RiskAll known or foreseeable hazards have been analyzed.Evaluation of Residual RiskAfter the above analysis and carrying out corresponding risk control measures, the residual risks of the potenti

32、al hazards associated with the use of the device according to the intended use are acceptable. The device has passed the tests required by the harmonized standards, which also proves that risks associated with the device are acceptable.The risk control measures have not introduced any new hazards. A

33、fter all risk control measures have been implemented and verified, there are no ALARP or N/ACC risks, so the risk/benefit analysis is not necessary.Information updating and risk management after manufacturingWe will collect and update the information from producing client complaining, similarity des

34、ign and so on, and then according the “medical device risk management procedure review and manage the information ItemUpdating informationS（F/BL（F/B）R（F/B）Control measurevalidationNHALORAppendix A. Analysis methodHarm analysis methodReasonable may foresee situationThe harm involves objectHarm initia

35、l reasonConsideration questionWhen analysis the harms, must consider reasonable may foresee situation, including: Under regular service condition; Under un-regular service conditionsIf is suitable, the harm analysis should include: Regarding patients harm; Regarding operators harm; Regarding service

36、mans harm; Regarding nearby personnels harm; Regarding environment harm.If is suitable, the harm initial reason should include: Human factor including man-machine engineering limit; Hardware breakdown; Software breakdown; Comprehensive mistake; Environmental condition.If is suitable, considered the

37、question includes: System part compatibility, including hardware and software; User interface, including instruction language, warning and error message; In user interface and instruction for use language translation accuracy; Prevented the human intends or has no intention behavior data protection

38、measure; Risk/Profiting criterion; Third party software.Risk estimate methodThe risk estimate of out body diagnoses instrument - - Analysis result confidence level; - - Specious inspection; - - Comparison usability and use; - - Is suitable for the medical laboratory quality assurance measure/Method;

39、 - - Flaw/Wrong detect ability; - - Service condition (for example emergency case); - - Specialist/Laymans use;- - The method provides informationAppendix B. Analysis MethodB.1. Estimation of the severity of each hazardTable SEQ 表 * ARABIC 3 Estimating severity of each hazardLevelSeverityInjury to h

40、umanHazard to diagnostic or treatment informationHazard to the equipmentHazard to environment4catastrophicDeath, severe physical functional disorder or mental derangement and all kinds of serious injury requiring cares. Serious destroy of environment3Critical Physical functional disorder or mental d

41、erangement, which leads to difficulty of normal life or requires hospitalization.Radiation exposure exceeding the limits stipulated by ICRP (1990).Improper treatment or hospitalization caused by misdiagnosis. Explosive breakdown. Energy emission or dropping with fatal power.Building catches fire. Co

42、ntamination of hazardous material2Marginal Temporary damage to body structure as a result of accident, which does not endanger the life but requires medical treatment. Equipment catches fire.Equipment is damaged and cannot be used again. Part of the building or other equipment catches fire.1Negligib

43、le Slight injury, burn or pain, which requires simple medical care. No mark will be left.Incorrect measurement data. Misjudgment caused by abnormal image, incorrect labeling, incorrect filing and lost data for diagnostic radiation exposure. Equipment catches fire or is damaged partially. Equipment c

44、an be used after repair.Unwanted movement of gantry, table, or detector.B.2. Estimation of the likelihood of each hazardTable SEQ 表 * ARABIC 4 Estimating acceptability of each riskLevelLikelihoodAccident rate (year/device)description6Frequent1.E-02It is a high frequent single fault condition and imm

45、ediately becomes dangerous by carelessness or malfunction.5Probable1.E-021.E-03Reliable component or circuit is single fault condition and becomes dangerous.Failure becomes dangerous by carelessness and malfunction.4Occasional1.E-031.E-04Two or three factors including operations of users occur at th

46、e same time and it becomes dangerous.3Remote1.E-041.E-05Two or three factors not including operation of users occur at the same time and it becomes dangerous.2Improbable1.E-051.E-06More than three factors independent of each other strongly occur at the same time and it becomes dangerous.1Incredible1.E-06M