Risk Management Software
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Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about. I need something that will facilitate generating the Risk Assessment Records, scoring the severity and occurrence, calculating the action required (BAR, ALARP, intolerable), tracking the risk mitigation, and re-scoring. It would be great if it also took a database of hazards as inputs. As far as I can tell, EVERYONE that develops software for medical devices (and probably other "safety critical" software as well) goes through this, but I am surprised that I cannot find a package that helps. We do it with Excel and it's a little tedious. I'm interested in all packages, large, small, expensive, free. Any input is appreciated! Stuart
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Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about. I need something that will facilitate generating the Risk Assessment Records, scoring the severity and occurrence, calculating the action required (BAR, ALARP, intolerable), tracking the risk mitigation, and re-scoring. It would be great if it also took a database of hazards as inputs. As far as I can tell, EVERYONE that develops software for medical devices (and probably other "safety critical" software as well) goes through this, but I am surprised that I cannot find a package that helps. We do it with Excel and it's a little tedious. I'm interested in all packages, large, small, expensive, free. Any input is appreciated! Stuart
This software does machinery safety. It may not be suitable but worth a look. www.laidler.co.uk/software.html
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Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about. I need something that will facilitate generating the Risk Assessment Records, scoring the severity and occurrence, calculating the action required (BAR, ALARP, intolerable), tracking the risk mitigation, and re-scoring. It would be great if it also took a database of hazards as inputs. As far as I can tell, EVERYONE that develops software for medical devices (and probably other "safety critical" software as well) goes through this, but I am surprised that I cannot find a package that helps. We do it with Excel and it's a little tedious. I'm interested in all packages, large, small, expensive, free. Any input is appreciated! Stuart
Failure Modes and Effects Analysis (FMEA)[^] is the standard approach for medical devices. I've always used Word+Visio for the documentation and have never investigated software packages for this purpose. A quick search on 'FMEA' did come up with a few commercial products and Excel templates though. Risk analysis will be tedious (actually, painful for most) no matter what tools you use.
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Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about. I need something that will facilitate generating the Risk Assessment Records, scoring the severity and occurrence, calculating the action required (BAR, ALARP, intolerable), tracking the risk mitigation, and re-scoring. It would be great if it also took a database of hazards as inputs. As far as I can tell, EVERYONE that develops software for medical devices (and probably other "safety critical" software as well) goes through this, but I am surprised that I cannot find a package that helps. We do it with Excel and it's a little tedious. I'm interested in all packages, large, small, expensive, free. Any input is appreciated! Stuart
Stuart Rubin wrote:
Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about.
The DoD has its own methods, a chart you fill out. At least the Army does. It started about a year ago and is very straight forward compared to prior methods. One side is possible outcome (worst case) and the other is chance of that outcome. You match the two in x,y and you have your risk analysis value. I don't have the chart here, but there is no software, and you have to fill out the official form (though luckily not in blood with your first born attached). :) theoretically we are supposed to be doing the same form in our head for all actions at home or at work.
_________________________ Asu no koto o ieba, tenjo de nezumi ga warau. Talk about things of tomorrow and the mice in the ceiling laugh. (Japanese Proverb)
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Stuart Rubin wrote:
Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about.
The DoD has its own methods, a chart you fill out. At least the Army does. It started about a year ago and is very straight forward compared to prior methods. One side is possible outcome (worst case) and the other is chance of that outcome. You match the two in x,y and you have your risk analysis value. I don't have the chart here, but there is no software, and you have to fill out the official form (though luckily not in blood with your first born attached). :) theoretically we are supposed to be doing the same form in our head for all actions at home or at work.
_________________________ Asu no koto o ieba, tenjo de nezumi ga warau. Talk about things of tomorrow and the mice in the ceiling laugh. (Japanese Proverb)
El Corazon wrote:
theoretically we are supposed to be doing the same form in our head for all actions at home or at work.
... in practice your client refuses to allow you to bill them for doing so and as a result you aren't?
Otherwise [Microsoft is] toast in the long term no matter how much money they've got. They would be already if the Linux community didn't have it's head so firmly up it's own command line buffer that it looks like taking 15 years to find the desktop. -- Matthew Faithfull
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Stuart Rubin wrote:
Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about.
The DoD has its own methods, a chart you fill out. At least the Army does. It started about a year ago and is very straight forward compared to prior methods. One side is possible outcome (worst case) and the other is chance of that outcome. You match the two in x,y and you have your risk analysis value. I don't have the chart here, but there is no software, and you have to fill out the official form (though luckily not in blood with your first born attached). :) theoretically we are supposed to be doing the same form in our head for all actions at home or at work.
_________________________ Asu no koto o ieba, tenjo de nezumi ga warau. Talk about things of tomorrow and the mice in the ceiling laugh. (Japanese Proverb)
Corazon, that "form" sounds like one piece of the puzzle. We (and I think most people in Medical Devices) score severities as a function of outcome (i.e. technician gets irradiated, patient has pain, etc.) and the probability (incredible, remote, etc.) which leads you to the severity (it's acceptable, it's as good as can be, it's intolerable). The trick then is to organize your requirements (which are generated in part as mitigations of the risks), the risk assessment, mitigations, and re-assessments in a methodical manner. In theory, it's pretty straight forward, but in practice, when you have multiple people working on multiple inter-dependent devices (each with software) some of which are from third-parties, it gets very complex. So, if anyone is reading this and uses a software tool to help, please speak up! Thanks. Stuart
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Can anyone recommend a good tool for Risk Management? If you develop medical, FAA, DOD, nuclear, or other "highly regulated" software, you'll know what I'm talking about. I need something that will facilitate generating the Risk Assessment Records, scoring the severity and occurrence, calculating the action required (BAR, ALARP, intolerable), tracking the risk mitigation, and re-scoring. It would be great if it also took a database of hazards as inputs. As far as I can tell, EVERYONE that develops software for medical devices (and probably other "safety critical" software as well) goes through this, but I am surprised that I cannot find a package that helps. We do it with Excel and it's a little tedious. I'm interested in all packages, large, small, expensive, free. Any input is appreciated! Stuart
We just purchaged the Relex Reliability Studio Team Edition[^] that does Reliability / FMEA or FMECA / FRACAS / Fault Tree / Human Factors Risk Analysis / Reliability Block Diagram ... the FAA is really into MTBF numbers now...
Steve
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El Corazon wrote:
theoretically we are supposed to be doing the same form in our head for all actions at home or at work.
... in practice your client refuses to allow you to bill them for doing so and as a result you aren't?
Otherwise [Microsoft is] toast in the long term no matter how much money they've got. They would be already if the Linux community didn't have it's head so firmly up it's own command line buffer that it looks like taking 15 years to find the desktop. -- Matthew Faithfull
dan neely wrote:
... in practice your client refuses to allow you to bill them for doing so and as a result you aren't?
no, I have always been low risk, per se. But if I followed the form to the letter, and always chose a path of lowest risk, I would not be working there. I would not be driving on roads in NM, and I would never leave the house. You can't judge every action as a least-risk choice, because some paths you must take, so you choose the least risky while still taking that path. It is risky working for the DoD, so if I chose the least risky choice always, I would have to change jobs. Driving in NM is risky, and it is safer to lock yourself in a house than to leave it. The new rules make the old risk analysis look much harder, but in application you can't just always "choose the safest route" by selecting the lowest score of all your choices. You do the best you can, with the choices you must make.
_________________________ Asu no koto o ieba, tenjo de nezumi ga warau. Talk about things of tomorrow and the mice in the ceiling laugh. (Japanese Proverb)