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1、Risk Management for Medical Devices,Safe and Effective Products Paul McDaniel ASQ CQM/OE Executive VP Operations and QA Sicel Technologies,Overview,Product Life Cycle Model Role Process Hints In-depth discussion of a Risk Management Analytical Tool: FMEA,Risk Management Defined (a practitioners defi
2、nition),Risk: probability of harm occurring AND the severity of harm Risk Management: Use of relevant information to identify possible harmful events, to assess the events acceptability in the eyes of the at risk population (probability*severity), and exert effective controls of the risk,Risk Analys
3、is -Intended use and Id of Char related to safety of the device -Id hazards -Est risk for each hazardous situation,Risk evaluation,Risk Control -Option analysis -Implement controls -Residual risk evaluation -Risk/benefit analysis -Risks arising from control measures -Completeness of risk control,Ris
4、k Assessment,Evaluation of overall residual risk acceptability,Risk Management Report,Production and post-production information,Risk Management,Adapted from ISO 14971:2007 Figure 1,Product Life Cycle Model Role,Understand the Regulatory Model A product life cycle has many phases Information/Product
5、s/Design at the start of a phase is input; possibly input requirements Information/Products/Design at the end of each phase is output Outputs must be verified against inputs The model assumes verification at each phase end,Product Life Cycle Model Role,The Current State of the Risk Management Standa
6、rd Assumes the Regulatory model You may follow the described process and be confused unless you recognize the phase boundaries How can I determine the answer to “is risk acceptable” if Im just defining design inputs The planned mitigation is acceptable, detail design may introduce new information, s
7、tay alert in the next phase!,Risk Management by Phase,Design Input (Hazard Analysis/Fault Tree) Focus on generating product “shall not do” or “shall comply with standard.” type of specification requirements Detailed Design (Fault Tree/FMEA) Look to your product architecture and add architecture inte
8、rface risks to your analyses Further on, examine higher risk areas and product failure risks in detail,Risk Management by Phase,Design Verification/Validation Watch for occurrence of anticipated but “intended to be” mitigated risks Risk Control failure Assess impact of V&V findings for new risks nee
9、ding analyses We didnt imagine that would happen: Risk? Listen to any customer feedback for risk acceptability “Those safety lock outs are too confusing to work with, can we disable them?”,Risk Management by Phase,Commercial Distribution/Disposal Vigilance Reporting is a Risk Analysis Update Opportu
10、nity NEW for 2007! Production feedback into the Risk Analysis Am I seeing higher rates of occurrence? Are new failure modes presenting themselves that we havent analyzed? Are we having control failures or excessive cause failures,Risk Analysis in Production,Non-conforming material and Material Revie
11、w Board Processes? Can they effectively consider risks on each occurrence? Control charts, acceptance data Are risk controls part of acceptance testing? Frequency of occurrence suggesting anything “Risk of failure was ranked as remote yet weve had three catastrophic hot-pot test failures this month!
12、”,Risk Analysis in Production,Comment period,Process Considerations,Define the scope of your analysis What systems, what interfaces, who as user. The records produced will be subject to second guessing if harm occurs: dont allow hindsight to change the rules Document your information sources! When y
13、ou made your risk acceptability decision, what information was available and used? We can only be diligent, not psychic,Analysis Scope,Intended Use: Use for which the product, process or service is intended according to the specifications, instructions, and information supplied by the manufacturer E
14、ssential Performance: Performance necessary to achieve freedom from unacceptable risk Note: is most easily understood by considering whether its absence or degradation would result in an unacceptable risk You must have these two clearly in front of the analysis team.,Process Considerations,Use a Ris
15、k Source List as a Reminder ISO 14971 has such lists Add your Industrys Experience If a harmful event has been reported, it has higher mitigation priority than hypothetical risks flag real occurrences in your analyses Rely on accepted standards If there is a “test” standard, understand the underlyin
16、g reason for the tests,Process Considerations,Sources of harm should suggest action electricity is not harmful, electrocution is A hazard exists A sequence of events leads to a hazardous situation (normal or fault conditions) The hazardous situation has a probability (P1) Harm occurs from the situation A probability of harm exists (P2) A severity of outcome can be assigned (S) Risk = S, P1 x P2,Process Considerations,While defining the system inputs, what harmful things can oc
