Thanks to everyone who participated in the “5 Keys to Improving Visibility into Risk” webinar. The webinar recording is now available if you weren’t able to attend or if you would like to watch it again. Additionally, the questions and answers from the webinar follow the video.
Questions & AnswersHow should I address concerns internally that improving risk identification and visibility will provide fodder to litigants in the event of a lawsuit?
Lawsuits are a reality of life. Unfortunately when something goes wrong, some people want to place the blame somewhere beside themselves—even if every reasonable safety precaution was taken by the manufacturer (including written instructions, which are often not read). My take on this issue is each of us, as a trustee of our company’s intellectual property, should document all of the “reasonable” precautions we take in manufacturing our product. Courts look for negligence. For me, documenting and managing potential risks, and being able to show that I’m doing so, is better than not being able to produce anything showing the safety of those products or, worse, hiding data. Managing and documenting a sound Risk Management process will help more than it could hurt in any potential litigation. After all, being able to show how you eliminated, mitigated, and chose to accept a potential risk will always look better than having no plan at all. Remember that data is not just something to hit you over the head. The numbers and data can’t be changed and can actually prove your side in a potential litigation.
Shouldn't risk mitigations also feed into the Product Requirements specification on the schema diagram that was shown?
Yes. Part of a sound risk management strategy is not simply identifying the risk but also mitigating that risk. Often, adding additional requirements are a way in which a risk might be mitigated. In addition, analysis of Product Requirements may in and of itself identify additional risks based on the feature set being implemented.
How hard is it to integrate TestTrack with Safety Assurance Case development tools?
Each integration is different, and the difficulty depends on the tool being integrated with TestTrack and exactly what the integration needs to accomplish. However, TestTrack has a robust API
that enables nearly unlimited integration possibilities. If you have a specific integration need, contact our Sales team
and they can provide more information about integration services.
Are the Severity field values you showed configurable, to enable organizations to match TestTrack with their risk processes and procedures?
Yes, all TestTrack field names, labels, and values are configurable.
Can RPN factors be tailored to include other factors, such as Detectability of Hazard should the risk be realized?
Yes, the RPN score field was using TestTrack’s calculated fields. To learn more about calculated fields, browse related blog posts
Are dFMEAs and pFMEAs linked or are they both their own risks?
dFMEAs and pFMEAs are their own type of risk. You would do a dFMEA on your designs and a pFMEA on your processes. While they are similar, they each address different types of risks to a system.
Are there Word templates or some other capability to get reports to external clients?
Yes, you can save any of the reports that TestTrack generates as HTML or PDF files and email those to clients. You can also provide limited access to external clients, enabling them to run reports in real-time without accessing other parts of the system.