Perhaps the question we should ask first is:
WHY MANAGE RISKS IN JIRA?
A growing number of software product companies in the world are already using Atlassian tools and enjoying the seamless integration between project and document management with easy tracking and monitoring of their work.
More and more companies are ready to abandon standalone tools for product development and start using one tech stack across their organization that all the employees are used to. Including your Quality Management department. Hopefully.
One of the integral parts of Quality Management for Safety-Critical Products is Risk Management, i.e. making sure that the product you are developing and looking forward to release carries no unacceptable risks when placed in the hands of their users.
HOW TO MANAGE PRODUCT RISKS IN JIRA?
SoftComply has developed two risk management apps on Jira: the SoftComply Risk Manager & the SoftComply Risk Manager PLUS.
On Jira Cloud, the SoftComply Risk Manager is your best choice. With the SoftComply Risk Manager app, you are able to customize your risk model/matrix and the risk table to fit your risk management process. There are embedded risk guidance templates that help you get started with FMEA or Hazard Analysis but you can also start building up your own template and use this in your next risk projects. It is easy to pull the risk data with the matrices and the table from Jira to Confluence so that you can build risk reports there for your risk management file – you can use the free Confluence extension for that.
If you are looking for a more complex risk management app for your high risk product and use Jira Server or Data Center, best try out the SoftComply Risk Manager Plus. Risk Manager Plus extends the functionality of the Risk Manager by providing an additional risk parameter to Severity and Probability/Occurrence – that is Detectability. You can choose to calculate risks into risk classes or RPNs (Risk Prioritization Numbers) as needed. In addition to Risk Management Plan and Report, there are also Risk Matrix and Risk Table reports that you can use to export them easily into different formats.
The following table illustrates the similarities and differences between the SoftComply Risk Manager vs Risk Manager Plus. Note that all the features have been described in greater detail below the table.
Embedded Risk Management Guidance
Both the Risk Manager and the Risk Manager Plus have embedded risk management guidance within the app which can help you set up your very first risk management project. For example, if you are a medical device developer, you will need to follow ISO 14971 Hazard Analysis as a minimum. You can choose the Hazard Analysis template when you start your first risk project that will provide you the required data fields in your risk project to start with. You can further customize the project configuration and re-use that configuration in your future risk projects.
Embedded Risk Management Guidance for Creating New Risk Projects
RISK CALCULATION & VISUALIZATION
In the SoftComply Risk Manager you will have 2 risk parameters for your Risk Class calculation – Severity and Probability. You can customize the number of the Severity/Impact and Probability/Occurrence levels in your risk projects as you need.
SoftComply Risk Manager – 2 risk parameters
In the SoftComply Risk Manager PLUS, you can have 3 risk parameters – Severity/Impact, Probability/Occurrence and Detectability. With these 3 parameters you can easily manage a more complex product FMEA.
SoftComply Risk Manager PLUS – 3 risk parameters
Risk Class calculation – both SoftComply Risk Manager apps support Risk Class calculation and visualization of them in Risk Matrices – the Initial and Residual Risk Matrices.
Risk Visualization in Initial and Residual Risk Matrices
Risk Prioritization Numbers – in the SoftComply Risk Manager Plus you can choose to calculate risks also in RPNs and visualize them in Risk Levels in addition to the Risk Matrices. RPNs are often used in FMEAs, particularly in FMEAs with Detectability parameter.
Risk Visualization in Risk Prioritization Numbers and Risk Levels
Integrated Risk Reports
Both SoftComply Risk Manager apps have integrated risk reports based on the requirements of ISO 14971. The Risk Management Plan pulls in your Risk Matrices configuration and the Risk Management Report pulls in the Initial and Residual Risk Matrices with the risk counts. You can export both of these reports to Word to add additional information about your product there.
Risk Reports in Confluence Cloud
The SoftComply Risk Manager Cloud has a free extension in Confluence that supports adding Risk Matrices and Risk Table to your Confluence pages. Using this extension will help build risk reports in real time with the data you want to visualize for risk approvals or just risk tracking.