ISO 14971 2007 Annex E Risk Management Report

1、RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 1 of 14Written By:Reviewed By:REV. ECN HistoryDateAPPROVALSAPPROVALNAMEFUNCTIONSIGNATUREDATEDirector of EngineeringOperations ManagerProject EngineerPRODUCTS:Product NameModel No.Engineering No.RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 2

2、of 14Table of ContentsTABLE-E.1 ENERGY HAZARDS.4ELECTROMAGNETIC ENERGY.4RADIATION ENERGY.4MECHANICAL ENERGY.4TABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDS.5BIOLOGICAL.5CHEMICAL.5BIOCOMPATABILITY.6TABLE-E.1 OPERATIONAL HAZARDS.6FUNCTION.6USE ERROR.7TABLE-E.1 INFOMATION HAZARDS.7LABELING.7OPERATATING INST

3、RUCTIONS.8WARNINGS.8TABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCES.9INCOMPLETE REQUIREMENTS:.9MANUFACTURING PROCESSES .9TRANSPORT AND STORAGE.10ENVIROMANTAL FACTORS .10CLEANING, DISENFECTING, AND STERIALIZATION.10DISPOSAL AND SCRAPPING.11FORMULATION .11HUMAN FACTORS .12FAILURE MODES.13Conclusion:.14T

4、o be completed per instructions SOP-XX-XXRisk Management, current revision, in conjunction with standard ISO 14971 and MDD 93/42/EEC Note: ALL Boxes in matrix must have an entry whether applicable or not. (Use N/A for boxes which are not applicable, The ACTION TAKEN Box must be filled out for an exp

5、lanation “Why it is not Applicable”)RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 3 of 14PROBABILITY OF OCCURRENCEPROBABILITY RANGEDESCRIPTIONFREQUENT 10-3OCCURRING OFTEN OR REPEATEDLYPROBABLE 10-3 and 10-4REASONABLY LIKELY TO OCCUROCCASIONAL 10-4 and 10-5IRREGULAR OCCURRENCE, INFREQUENTREMOTE

6、 10-5 and 10-6NOT LIKELY TO OCCURIMPROBABLE 10-6 UNLIKELY TO EVER OCCURSEVERITYDESCRIPTIONCATASTROPHICRESULTS IN PATIENT DEATHCRITICALRESULTS IN PERMANENT IMPAIRMENT OR LIFE-THREATENING INJURYSERIOUSRESULTS IN INJURY OR IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTIONMINORLOW RISK FAILURE NOT

7、EXPECTED TO CONTRIBUTE TO AN INJURYNEGLIGIBLEINSIGNIFICANT FAILURE NOT SERIOUS ENOUGH TO CONTRIBUTE TO AN INJURYSEVERITY CATEGORIESPROBABILITY OFOCCURRENCENEGLIGIBLEMINORSERIOUSCRITICALCATASTROPHICFREQUENT147531PROBABLE169752OCCASIONAL1812964REMOTE191513118IMPROBABLE2017151310HAZARD RISK INDEXACCEPT

8、ANCE CRITERIA1 TO 5UNACCEPTABLE6 TO 9UNDESIRABLE. WRITTEN & REVIEWED DECISION TO PROCEED10 TO 16ACCEPTABLE UPON COMPLETION OF QUALITY ASSURANCE/REGULATORY REVIEW17 TO 20ACCEPTABLE WITHOUT REVIEWRISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 4 of 14Examples of hazards, foreseeable sequences

9、of events and hazardous situations from EN ISO 14971:2007 Annex ETABLE-E.1 ENERGY HAZARDSELECTROMAGNETIC ENERGYHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENLine VoltageYes NoDesign LabelEnclosure Leakage currentYes NoDesign LabelEarth Leakage currentY

10、es NoDesign LabelPatient Leakage currentYes NoDesign LabelElectric FieldsYes NoDesign LabelMagnetic FieldsYes NoDesign LabelRADIATION ENERGYHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENIonizing radiationYes NoDesign LabelNon-ionizing radiationYes NoDe

11、sign LabelMECHANICAL ENERGYHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENGravity - FallingYes NoDesign LabelGravity suspended massesYes NoDesign LabelVibrationYes NoDesign LabelStored EnergyYes NoDesign LabelMoving PartsYes Design RISK MANAGEMENT REPOR

12、T NO. RM-(PROJECT #)-00X Sheet 5 of 14 No LabelTorsion, shear and tensile forceYes NoDesign LabelMoving and positioning of patientYes NoDesign LabelAcoustic energy - ultrasonic energyYes NoDesign LabelAcoustic energy - infrasound energyYes NoDesign LabelAcoustic energy - soundYes NoDesign LabelHigh

13、pressure fluid injectionYes NoDesign LabelTABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDSBIOLOGICALHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENBacteriaYes NoDesign LabelVirusesYes NoDesign LabelOther agents (e.g. prions)Yes NoDesign LabelRe- or cross-infec

14、tionYes NoDesign LabelCHEMICAL Exposure of airway, tissues, environment or property e.g. to foreign materialsHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENAcids or alkalisYes NoDesign LabelresiduesYes NoDesign LabelcontaminantsYes NoDesign LabelAddicti

15、ves or processing aidsYes NoDesign LabelCleaning, Yes Design RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 6 of 14disinfecting or testing agents No LabelDegradation productsYes NoDesign LabelMedical gassesYes NoDesign LabelAnesthetic productsYes NoDesign LabelBIOCOMPATABILITY, Toxicity of chem

16、ical constituents, e.g.HAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENAllergenicity/ irritancyYes NoDesign LabelPyrogenicity (induce fever)Yes NoDesign LabelTABLE-E.1 OPERATIONAL HAZARDSFUNCTIONHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF F

17、AILURERESPONSERISKINDEXACTION TAKENIncorrect or inappropriate output or functionalityYes NoDesign LabelIncorrect measurementYes NoDesign LabelErroneous data transferYes NoDesign LabelLoss or deterioration of functionYes NoDesign LabelUSE ERRORHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF

18、 FAILURERESPONSERISKINDEXACTION TAKENAttentional failureYes NoDesign LabelMemory failureYesDesign RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 7 of 14 No LabelRule-based failureYes NoDesign LabelKnowledge- based failureYes NoDesign LabelRoutine ViolationYes NoDesign LabelTABLE-E.1 INFOMATION

19、HAZARDSLABELINGHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENIncomplete instructions for useYes NoDesign LabelInadequate description of performance characteristicsYes NoDesign LabelInadequate specification of accessories to be used with the medical dev

20、iceYes NoDesign LabelInadequate disclosure of limitationsYes NoDesign LabelOPERATATING INSTRUCTIONSHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENInadequate specification of accessories to be used with the medical deviceYes NoDesign LabelInadequate YesD

21、esign RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 8 of 14specification of pre-use checks No LabelOver-complicated operating instructionsYes NoDesign LabelWARNINGSHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENWarnings of side effectsYes NoDesign

22、 LabelWarnings of hazards likely with re-use of single-use medical devicesYes NoDesign LabelSPECIFICATION OF SERVICE AND MAINTENANCEHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENInadequate specification of when service and maintenance is requiredYes No

23、Design LabelTABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCESINCOMPLETE REQUIREMENTS, Inadequate Specification of:HAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENDesign parametersYes NoDesign LabelOperating YesDesign RISK MANAGEMENT REPORT NO. RM-(PROJECT #)

24、-00X Sheet 9 of 14parameters No LabelPerformance requirementsYes NoDesign LabelIn-service requirements (e.g. maintenance, reprocessing)Yes NoDesign LabelEnd of lifeYes NoDesign LabelMANUFACTURING PROCESSES, Insufficient control of:HAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESP

25、ONSERISKINDEXACTION TAKENChanges to manufacturing processYes NoDesign LabelMaterials / materials compatibility informationYes NoDesign LabelManufacturing processesYes NoDesign LabelsubcontractorsYes NoDesign LabelTRANSPORT AND STORAGEHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURER

26、ESPONSERISKINDEXACTION TAKENInadequate packagingYes NoDesign LabelContamination or deteriorationYes NoDesign LabelInappropriate environmental conditionsYes NoDesign LabelRISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 10 of 14ENVIROMANTAL FACTORSHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFF

27、ECTS OF FAILURERESPONSERISKINDEXACTION TAKENPhysical (e.g. heat, pressure, time)Yes NoDesign LabelChemical (e.g. corrosions, degradation, contamination)Yes NoDesign LabelElectromagnetic fields (e.g. susceptibility to electromagnetic disturbance)Yes NoDesign LabelInadequate supply of powerYes NoDesig

28、n LabelInadequate supply of coolantYes NoDesign LabelCLEANING, DISENFECTING, AND STERIALIZATIONHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENLack of, or inadequate specification for, validated procedures for cleaning, disinfecting and sterilization.Yes

29、 NoDesign LabelInadequate conduct for cleaning, disinfecting and sterilizationYes NoDesign LabelDISPOSAL AND SCRAPPINGHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENNo, or Yes Design RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 11 of 14inadequate

30、 information provided. No LabelUse errorYes NoDesign LabelFORMULATIONHAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENBiodegrationYes NoDesign LabelBiocompatibilityYes NoDesign LabelNo Information or inadequate specification providedYes NoDesign LabelInad

31、equate warnings of hazards associated with incorrect formulationsYes NoDesign LabelUse errorYes NoDesign LabelHUMAN FACTORS, Potential for use errors triggered by design flaws, such as:HAZARDAPPLICABLEPOTENTIALFAILURECAUSE OFFAILUREEFFECTS OF FAILURERESPONSERISKINDEXACTION TAKENConfusing or missing

32、instructions for useYes NoDesign LabelComplex or confusing control systemYes NoDesign LabelAmbiguous or unclear device stateYes NoDesign LabelAmbiguous or unclear Yes NoDesign LabelRISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 12 of 14presentation of settings, measurements or other information

33、Misrepresentation of resultsYes NoDesign LabelInsufficient visibility, audibility of tactilityYes NoDesign LabelPoor mapping of controls to actions, or of displayed information to actual stateYes NoDesign LabelControversial modes or mapping as compared to existing equipmentYes NoDesign LabelUse by unskilled/untrained personnelYes NoDesign LabelInsufficient warnings of side effectsYes NoDesign LabelInadequate warnings of hazards associated with re-use of single-use medical devicesYes NoDesign LabelIncorrect measurement and other metrological aspects. Yes NoDesign LabelIncompatibility Yes