Bottom up approach versus system level

racglobal

Involved In Discussions
#1
Hello everyone,

How does a product development team know whether to take a bottom-up approach or a top-down approach when doing a hazard analysis? Is it recommended that a team perform both types of analysis? Is there a specific approach recommended for hardware devices containing software? For example, an electromedical device used for imaging (for diagnostic or therapeutic purpose). ISO 14971 may be limited as a risk management tool. I was wondering if people have experiences with anything other than ISO 14971.

Thanks.
 
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#2
Best to do both, but that is not always possible. ISO 14971 references IEC 61025 for fault tree analysis and 60812 for FMEA. Why do you believe ISO 14971 is limited? If you have a medical device, you are pretty much required to follow this standard. ISO 14971 is flexible in the way that it can be implemented. There are many different ways you can determine and document the hazardous situations associated with your device.
 

Tidge

Trusted Information Resource
#3
Hello everyone,

How does a product development team know whether to take a bottom-up approach or a top-down approach when doing a hazard analysis? Is it recommended that a team perform both types of analysis? Is there a specific approach recommended for hardware devices containing software? For example, an electromedical device used for imaging (for diagnostic or therapeutic purpose).
In my experience, the risk management story is best told "top down" but that a 'bottom up' process is useful to get developers thinking (albeit in a post-hoc manner) about the reasons for some of their design choices. "Top down" tends to drive a more comprehensive analysis of risk controls, especially when the use cases are incorporated at the beginning of the process. "Bottom up" approaches have a tendency to feel like "solutions in search of problems", which will miss risks for which developers did not establish controls.

From the brief description of your product, you probably want your risk analysis to clearly explore (among other things) the risks around the device being used for "direct diagnosis" and/or "providing decisive information" even if you haven't classified your device as such. It is not uncommon for some devices to walk the line between presenting "indicative" and "decisive" information.

For extra bonus work (and what development team doesn't want to do more risk management activities?), you can mirror/parallel your risk management process (whatever approach is taken) to address cybersecurity risks and their controls. A mature risk control process that includes cybersecurity will have the ability to establish links between the two areas of risk.
 
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