Risk management report (Example -1)

SPS Risk Management ReportDocument Reference NoFM:KF-043AIssued DateApr 3, 2011Revised dateEdited byApproved by Mr. Hu sanhong Mr Zhu HongweiTable of Content1.Preface2.Risk management evaluation personnel information3.1. Policy3.2. Criteria for risk acceptability 4. Risk analysis - 4.1. Risk analysis procedure - 4.2. Intended use/ purpose - 4.3. Identify hazards - 4.4. Estimation of risk of each hazard 5. Risk evaluation 6. Risk control - 6.1. Risk reduction - 6.2. Risk control option analysis - 6.3. Implementation of risk control measure- 6.4. Residual risk evaluation - 6.5. Risk/benefit analysis - 6.6. Other generated hazards - 6.7. Completeness of risk evaluation 7. Overall residual risk evaluation 8. Post-Production Information9. Risk Management Conclusion1. PrefaceThis document is Risk management report of Switching PowerSupply In the report all possible harm and its cause have been assessed, each harm severity degree and occurrence probability have been evaluated. Well have harm decrease measure when a certain harm level is inacceptable. Meanwhile, all the remaining harm after taking harm measure have been assessed, all the remaining harm level have been changed to be acceptable. This report is applicable to design & development of Switching PowerSupply and products small-scale production phase. The Switching PowerSupply is composed of open frame and inner electronic circuit. Reference standards:ItemDescriptionSafetyANSI/AAMI ES60601-1:2005EMCIEC 60601-1-2: 2004+A1: 2005Quality SystemISO 13485:2003 Risk ManagementISO 14971:2007 2. Risk management evaluation personnel informationMembers that take part in risk identification, risk evaluation, risk assessment and risk control. NameTitleResponsibility Zhu Hong WeiGeneral ManagerApprove product risk acceptable and risk management report. Estimate the harm extentTina ZouMarketing managerResponsible for implement of risk management whole process, evaluate the probability of hardware malfunction from technical issue Hu SanhongR&D SupervisorEvaluate the risk of production, Evaluate the risk of operatorYang MengQA managerEvaluate the risk of inspection3.1 Policy Risk management activities at Switching Power Supply are based on the ISO 14971:2007 Application of risk management to medical devices.The policy is based on Safety standard ANSI/AAMI ES60601-1:2005 and EMC standard IEC 60601-1-2: 2004+A1: 2005, at the same time after risk management process which prescribed by this report thatwillsupplymaximum benefit and minimum harm to operators and patients; all the estimates of the risks, results of this risk evaluation, risk control option and The effectiveness of the risk control measures had been verified and the results of the verification were mentioned and recorded in the risk management file , All residual risk that remains after the risk control measure(s) are applied and evaluated using the criteria that defined in the risk management plan .All of the Risk shall be within acceptable region.3.2 Criteria for acceptability The severity of a hazard is classified in a number of classes. NoSeverity Level1negligibleInconvenience or temporary discomfort2minorResult in temporary injury or impairment not requiring professional medical intervention, 3SeriousResult in injury or impairment requiring professional medical intervention, 4CriticalResult in permanent impairment or life-threatening injury, 5CatastrophicResult in patient deathThe probability of occurrence of a hazard will be different for the different causes. The probability is classified in a number of classes using 5 classes:NoProbability Level1improbable 10-62Remote 10-5 and 10-63occasional 10-4 - 10-54probable 10-3 - 10-45frequent10-3The acceptance criteria are as the table following:SeverityProbability 1 negligible2 minor3 Serious4 Critical5 Catastrophic5 frequentNACCNACCNACCNACCNACC4 probableNACCNACCNACCNACCNACC3 occasionalACCACCNACCNACCNACC2 RemoteACCACCACCNACCNACC1 improbableACCACCACCACCACCNACC = not acceptable regionACC = acceptable region4. Risk analysis 4.1 Risk analysis procedure The risk management process will be conducted follow the process below and company Risk Management procedure PRKF002.- 4.2. Intended use/ purpose 4.2.1 Intended use: TheSwitching PowerSupply (SPS) are intended to supply home applications or IT equipment and office equipment or medical device withsafe extra low voltage. The SPS is an appliance inlet type (or directly plugged in a socket outlet) while thedeviceto be supplied is connected with a cord and plug from the SPS. The power supply will be build-in end product which will be used by operators or patients.4.2.2 Technical Characteristics Model: SMPS-D2, SMPS-D2-LARGE, W60RA58-290020, W60RA65-290020Input: 100-240 V ac, 50-60 Hz, 1.5 A max. , Class II, IPX0 Output: 29Vdc, 2A l Operating temperature: 0 30l Operating relative humidity: 20% 95%l Storage and transportation temperature: 0 60l storage and transportation relative humidity: 20% 95%l Do not operate near fire or in high temperature ambient;l Do not use this SPS in a dusty ambient;l Only operate the SPS in dry rooms indoors. l Do not expose to water or other conductive liquid electric shock hazard.4.2.3 Lifetime The SPS was conceived for an intense and professional use, its longevity is guaranteed for 50000hrs at 25, which is based on the lifetime of the internal transformer4.2.4 Device appearance 4.2.5 Indication for Use:Please refer to the Use Manual. - 4.3. Identify hazards HazardsHazardous situationHarm R1Single Fault Condition for ME EquipmentDevice abnormal working, heating, fire, insulation breakdown, touch hazard voltage,May lead burn, electric shock R2Improper use components Cause component fault , unit doesnt working or abnormal working,May lead burn, electric shock or cannot workR3combination(s) of simultaneous component faultsunit doesnt working or abnormal working,May lead burn, electric shock or cannot workR4unfavorable working conditionsCause abnormal workingMay lead Temperature is too high or cannot workR5High Humidity usedinsulation breakdown, May lead electric shockR6lack of identification Improper useMay lead electric shockR7inadequacy protective packagingthe unit damagedMay lead cannot workingR8Inadequacy accompanying documents Improper useMay lead electric shockR9Inadequacy mechanical strength and resistance to heat of insulation materialInsulation breakdownMay lead electric shock,R10Fixing of components is not securelycircuit may be short or openedMay lead cannot workingR11Using of mains fuses is Inadequacy The fuse can not interrupt the maximum fault currentMay lead cannot workingR12skin contact with over 10 % of the head surfaceover heatMay lead burn,- 4.4. Estimation of risk of each hazard HazardsHazardous situationHarm Probability Severity R1Single Fault Condition for ME EquipmentDevice abnormal working, heating, fire, insulation breakdown, touch hazard voltage,May lead burn, electric shock occasionalCriticalR2Improper use components Cause component fault , unit doesnt working or abnormal working,May lead burn, electric shock or cannot workRemoteCritical R3combination(s) of simultaneous component faultsunit doesnt working or abnormal working,May lead burn, electric shock or cannot workimprobableCriticalR4unfavorable working conditionsCause abnormal workingMay lead Temperature is too high or cannot workoccasionalminorR5High Humidity usedinsulation breakdown, May lead electric shockRemoteSeriousR6lack of identification Improper useMay lead electric shockRemoteSeriousR7inadequacy protective packagingthe unit damagedMay lead cannot workingRemoteminorR8Inadequacy accompanying documents Improper useMay lead cannot workingRemoteminorR9Inadequacy mechanical strength and resistance to heat of insulation materialInsulation breakdownMay lead electric shock,RemoteSeriousR10Fixing of components is not securelycircuit may be short or openedMay lead cannot working, electric shockRemoteSeriousR11Using of mains fuses is Inadequacy The fuse can not interrupt the maximum fault currentMay lead burnRemoteCriticalR12skin contact with over 10 % of the head surfaceover heatMay lead burnimprobableSerious5. Risk evaluation HazardsHazardous situationHarm Probability Severity VerdictR1Single Fault Condition for ME EquipmentDevice abnormal working, heating, fire, insulation breakdown, touch hazard voltage,May lead burn, electric shock occasionalCriticalNACCR2Improper use components Cause component fault , unit doesnt working or abnormal working,May lead burn, electric shock or cannot workRemoteCritical NACCR3combination(s) of simultaneous component faultsunit doesnt working or abnormal working,May lead burn, electric shock or cannot workimprobableCriticalACCR4unfavorable working conditionsCause abnormal workingMay lead Temperature is too high or cannot workoccasionalminorACCR5High Humidity usedinsulation breakdown, May lead electric shockRemoteSeriousACCR6lack of identification Improper useMay lead electric shockRemoteSeriousACCR7inadequacy protective packagingthe unit damagedMay lead cannot workingRemoteminorACCR8Inadequacy accompanying documents Improper useMay lead cannot workingRemoteminorACCR9Inadequacy mechanical strength and resistance to heat of insulation materialInsulation breakdownMay lead electric shock,RemoteSeriousACCR10Fixing of components is not securelycircuit may be short or openedMay lead cannot working, electric shockRemoteSeriousACCR11Using of mains fuses is Inadequacy The fuse can not interrupt the maximum fault currentMay lead burnRemoteCriticalNACCR12skin contact with over 10 % of the head surfaceover heatMay lead burnimprobableSeriousACCSeverityProbability 1 negligible2 minor3 Serious4 Critical5 Catastrophic5 frequent4 probable3 occasionalR4R12 RemoteR7,R8R5,R6,R9,R10R2,R111 improbableR12R36. Risk control - 6.1. Risk reduction When risk reduction is required, risk control activities, as described in 6.2 to 6.7, shall be performed.- 6.2. Risk control option analysis HazardRisk Control OptionPre-Control ProbabilityPer-Mitigation SeverityProbabilitySeverityR1Single Fault Condition for ME EquipmentThe device have been designed protected by NTC, thermal link and main fuse; and manufactured that it remains safety at single fault condition according to ANSI/AAMI ES60601-1:2005.occasionalCriticalimprobableCritical R2Improper use components Improve producing and QC, The device have been designed protected by NTC, thermal link and main fuse; and manufactured that it remains safety at single fault condition according to ANSI/AAMI ES60601-1:2005.RemoteCritical improbableCritical R11Using of mains fuses is Inadequacy Improve producing and QC,RemoteCriticalimprobableCritical - 6.3. Implementation of risk control measure HazardRisk control optionImplementer of risk control Verifier of risk controlRisk control option validation of resultR1Single Fault Condition for ME EquipmentThe device have been designed protected by NTC, thermal link and main fuse; and manufactured that it remains safety at single fault condition according to ANSI/AAMI ES60601-1:2005.Tina ZouHu SanhongACCR2Improper use components Improve producing and QC, The device have been designed protected by NTC, thermal link and main fuse; and manufactured that it remains safety at single fault condition according to ANSI/AAMI ES60601-1:2005.Tina ZouHu SanhongACCR11Using of mains fuses is Inadequacy Improve producing and QC,Tina ZouHu SanhongACC- 6.4. Residual risk evaluationAfter the risk reduction, the residual risk situation is as following: SeverityProbability 1 negligible2 minor3 Serious4 Critical5 Catastrophic5 frequent4 probable3 occasionalR42 RemoteR7,R8R5,R6,R9,R101 improbableR12R3,R1, R2,R11All residual risk that remains after the risk control measure(s) are applied and evaluated using the criteria that defined in the risk management plan.All the risk is in acceptable area. - 6.5. Risk/benefit analysis In this risk analysis the presents state of the device has been evaluated, R1, R2 and R11 are under control. All the risk is in ACC area. Therefore, the overall risk is very low in this device. However, the benefit is obviously to its intended use. We think the Benefit is much bigger than the risk.- 6.6. Other generated hazards-HazardRisk control optionOther generated hazardsOther risk control optionR2Improper use components Improve producing and QC, The device have been designed protected by NTC, thermal link and main fuse; and manufactured that it remains safety at single fault condition according to ANSI/AAMI ES60601-1:2005.May be increased risk that employees dont understand the Improve measuresTo strengthen the training of employeesR11Using of mains fuses is Inadequacy Improve producing and QC,May be increased risk that employees dont understand the Improve measuresTo strengthen the training of employees- 6.7. Completeness of risk evaluation The risk(s) from all identified hazardous situations have been considered. The results of this activity shall be recorded in the risk management file.7. Overall residual risk evaluation Integrated with all the risk evaluation, all the risk is in acceptable area. SeverityProbability 1 negligible2 minor3 Serious4 Critical5 Catastrophic5 frequent4 probable3 occasionalR42 RemoteR7,R8R5,R6,R9,R101 improbableR12R3,R1, R2,R118. Post-production informationCompany has established and maintains a systematic procedure, Vigilance System, Procedure SOPYW004, and Corrective Action Procedure, PRPG0050, to review information gained about the medical device or similar devices in the post-production phase. The information shall be evaluated for possible relevance to safety, especially the following:a) if previously unrecognized hazards are present;b) if the estimated risk(s) arising from a hazard is no longer acceptable;c) if the original assessment is otherwise invalidated.If any of the above conditions is satisfied, the results of the evaluation shall be fed back as an input to the