Risk Assessment Risk Scoring Parameters Severity choose most

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Risk Assessment Risk Scoring Parameters Severity (choose most severe) Risk Ranking Likelihood 3 Highly

Risk Assessment Risk Scoring Parameters Severity (choose most severe) Risk Ranking Likelihood 3 Highly Likely > 50% 2 Somewhat Likely 20% - 50% 1 Rare 0 - 20% Score level to Change Color: Likelihood Severity RPN Red 3 3 7 Yellow 2 2 4 Green 1 1 1 Product Project Injury Complete product failure, does not function Complete project Severe injury, failure potential death Meets some customer needs and specifications, product performs with less functionality than desired Moderate impact Treatment to budget required schedule Performance of product is not impacted No impact to project budget or Minor or no injury schedule

Risk Assessment Risk Item Summary Likelihood (1 -3) Severity (1 -3) RPN Total Number

Risk Assessment Risk Item Summary Likelihood (1 -3) Severity (1 -3) RPN Total Number of 3's 2 3 62 Likelihood Severity Level Risk Priority Number Description/Comment Sensors Desired sensor accuracy not within budget 2 2 4 DAQ Dedicated DAQ system not within budget 3 3 9 Temperature Control Method for keeping constant temperature (98 deg F) not within budget 2 2 4 Controlling the flow restriction (resistance) using DAQ Resistance Automation not within budget 3 2 6 Compliance Specified compliance values not achieved 2 2 4 Specified resistance values not achieved 2 2 4 Temperature Human body temperature is not maintained 2 2 4 Viscosity variation does not simulate human blood properties 1 2 2 Cost Physiological Resistance Simulation

Risk Assessment Likelihood Severity Level Risk Priority Number Biocompatibility Not all necessary components are

Risk Assessment Likelihood Severity Level Risk Priority Number Biocompatibility Not all necessary components are biocompatible 2 2 4 Durability Valves, sensors, tubing degrade over time 1 2 2 Inaccurate measurements Pressure and flow measurements are inaccurate 1 2 2 DAQ Error Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly 2 3 6 Robustness System is not robust - variations in functionality and system output 2 2 4 Leak System or components leak causing error in measurement and/or contamination 2 2 4 Resistance Automation Flow restriction is not automated or does not function properly 1 3 3 Risk Item Materials Description/Comment Measurement Design