VIEWS: 2 PAGES: 3 POSTED ON: 3/4/2012
MSD Project Risk Assessment Template Imp Like Se ort liho ver anc ID Risk Item Effect Cause od ity e Action to Minimize Risk Owner Describe the risk briefly What is the effect on any What are the possible L*S What action(s) will you take (and by Who is or all of the project cause(s) of this risk? when) to prevent, reduce the impact responsible deliverables if the cause of, or transfer the risk of this for following actually happens? occurring? through on mitigation? Battery doesn't last Design for reliability and redundancy long enough 1 Power loss Fatal system failure 2 3 P*R Reliable battery TBD Battery failure Backup battery Short-circuit External Signals Shielding Wireless 2 Signal interference Unable to 2 3 R*A Filters TBD Communication Failure communicate Selecting proper frequencies through body tissue Inappropriate Harm to patient (esp shielding/enclosing strong enough and material Design for reliability and redundancy 3 Possible shock reaches heart) 2 3 P*R Ground TBD Static buildup Follow Biomedical Industry Standards Damage Hardware Short-circuit Harm to the patient’s Materials not Use safe materials 4 Materials Used Not Safe 2 3 P*R TBD body, may reject system accepted by body Follow Biomedical Industry Standards Sensor failure Design for reliability and redundancy Don’t know of any 5 Warning system fails Hardware/Software 2 3 P*R TBD possible dangers Follow Biomedical Industry Standards failure Poor UI Design Difficult to adjust 6 UI is hard to use Lack of customer 2 1 R Customer feedback TBD system feedback System cannot turn off Design for reliability and redundancy Wireless/Manual in case of emergency, Overall System 7 2 3 P*R Follow Biomedical Industry Standards TBD overrides failure posing grave danger to Failure patient Signal interference Wireless cannot Power loss Design for reliability and redundancy 8 Cannot adjust system 2 3 P*R TBD communicate to UI Overall wireless failure Imp Like Se ort ID Risk Item Effect Cause liho ver Action to Minimize Risk Owner anc od ity e Communications Cannot adjust system module/Hardware Testing and Research failure 9 RF Range is too small 1 3 P*R TBD Wireless communication Reduced power Reliable and redundant power failure Critical Research Failure Design Failure Customer Feedback Unable to meet size 10 Customer Needs failure Customer Needs too 3 2 P*R TBD constraints/pump specs severe Design Processes Wireless Communication Design for reliability and redundancy 11 Failure Cannot adjust system (Many) 2 3 P*R TBD (umbrella risk) Cannot accurately adjust Hardware Damage 12 Sensor Failure system, may be Software/Interface 1 3 P*R Testing TBD dangerous failure Cannot adjust system Chip damage 13 Microcontroller Failure Electrical Behavior 2 3 P*R Select hardy microcontroller TBD Wireless Anomalies Communication failure Software Bugs Software testing and reliability 14 Software Failure Overall System Failure Microcontroller 2 3 P*R TBD processes failure Reservoir corrosion Select appropriate material Removal of entire 15 System Leak 2 3 P*R TBD system Tubing/attachments leaking Check sealing before installation Short-Circuit generating high Implement protection circuit and use 16 Possible Burn to Tissue Harm to patient amount of heat, not 2 3 P*R TBD heat dissipating material dissipating heat from system properly Likelihood scale Severity scale 1 - This cause is unlikely to happen 1 - The impact on the project is very minor. We will still meet deliverables on time and within budget, but it will cause extra work 2 - This cause could conceivably happen 2 - The impact on the project is noticeable. We will deliver reduced functionality, go over budget, or fail to meet some of our Engineering Specifications. 3 - This cause is very likely to happen 3 - The impact on the project is severe. We will not be able to deliver, or what we deliver will not meet the customer's needs. “Importance Score” (Likelihood x Severity) – use this to guide your preference for a risk management strategy Prevent Action will be taken to prevent the cause(s) from occurring in the first place. Reduce Action will be taken to reduce the likelihood of the cause and/or the severity of the effect on the project, should the cause occur Transfer Action will be taken to transfer the risk to something else. Insurance is an example of this. You purchase an insurance policy that contractually binds an insurance company to pay for your loss in the event of accident. This transfers the financial consequences of the accident to someone else. Your car is still a wreck, of course. Accept Low importance risks may not justify any action at all. If they happen, you simply accept the consequences.
"Risk Management (DOC download)"