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Risk Management (DOC download)


									MSD Project Risk Assessment Template

                                                                                      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
                                                             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
                                                             External Signals
2    Signal interference                                     Unable to                2      3     R*A   Filters                                 TBD
                                 Communication Failure
                                                             communicate                                 Selecting proper frequencies
                                                             through body tissue
                                 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
                                 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
                                                             Poor UI Design
                                 Difficult to adjust
6    UI is hard to use                                       Lack of customer         2      1     R     Customer feedback                       TBD
                                 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
                                                             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
                                                                                            Like   Se
ID   Risk Item                         Effect                      Cause                    liho   ver          Action to Minimize Risk                  Owner
                                                                                            od     ity
                                       Cannot adjust system        module/Hardware
                                                                                                                Testing and Research
9    RF Range is too small                                                                  1      3     P*R                                             TBD
                                       Wireless communication      Reduced power
                                                                                                                Reliable and redundant power
                                       failure                     Critical Research
                                                                   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
                                       Communication failure
                                                                   Software Bugs
                                                                                                                Software testing and reliability
14   Software Failure                  Overall System Failure      Microcontroller          2      3     P*R                                             TBD
                                                                   Reservoir corrosion                          Select appropriate material
                                       Removal of entire
15   System Leak                                                                            2      3     P*R                                             TBD
                                       system                      Tubing/attachments
                                                                   leaking                                      Check sealing before installation
                                                                   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.

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