1Today: What is risk identification Example problem Tools and Methods2‘Risk’ - Any issue that could arise during a project or section of a project Commercial Technical User Experience Intellectual Property Manufacture Regulatory Health & Safety Etc...3Each ‘Risk’ has a severity rating based on how easily the risk could be overcomeif it occurs. The severity ratings are calculated by scoring risk against:– Impact - effect of risk on project outcome– Likelihood - probability of risk being realised– Scale - effort required to mitigate risk (this could also be used for associatedcost)– Uncertainty - degree of familiarity with identified risk4The Risk profileLikelihoodImpact51 515Scales Used For Scoring Risk (adapted to each project)1 2 3 4 5Negligible Minor benefit lostMajor benefit lost /cost target missed /phase repeatedCommercial viabilityof product marginalImpactProject failsExtremely unlikely Unlikely 50 / 50 likelihood LikelyLikelihoodExtremely likely< 1 week 1 week 1-3 weeks 1 MonthScale> 1 MonthWe have done itbeforeWe have donesimilar before orothers have solvedthis beforeOthers have solvedsimilar beforeNot solved beforebut it is clear how toapproach itUncertaintyResearch projectneeded beforeproblem can betackled6When to evaluate risk At the brainstorm phase– Selection criteria At the concept selection– Critical Path At technical review– Areas for further analysis Prior to manufacturing– Assembly– Process restrictions7You have been given the task to Designed the next generation Auto Injector8Methods to identify risk Module Part by part Function User Based9What are the next steps Make sure scores makes sense Identify risks that need mitigation Determine mitigation plan– How can you best reduce the likelihood that a problem will occur10Ways to reduce risk Research– Existing solutions– Similar mechanism– Talking with Manufacturers Modeling– Calculations– FEA Prototyping– Quick and dirty and Cheap11Prototyping Looks like Works like Made like Feels like (user studies) Dangers– Not representative of final system– Works good enough team not willing to iterate– Prototype to costly in time and money– Not considering how it will be made later (manufacturing tolerances /
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