- Install the SoftComply Risk Manager (from hereon, Risk Manager) from the Atlassian Marketplace to your Jira instance. This step may require Jira administration permission.
- After the successful installation, open the “Risk Manager” drop-down menu and create a new risk management project from the top navigation bar (see next step).
- The creation of the new risk management consists of the following three steps:
3.1. Fill in the name of the project, the project key and the project lead;
3.2. Select a suitable risk matrix from the matrix templates (the matrix can be customized later, if necessary);
3.3. Select a suitable risk management table template and click “Submit”.
Success! You have just created a new risk management project and you can now start managing risks in your projects.
Here is a short video tutorial guiding you through these steps – SoftComply Risk Manager Quick Start Guide:
1. If you have managed your risks in Excel before, you can import these risks to your newly created risk management project in the Risk Manager by using Jira’s own import options. Please follow our importing instructions to successfully import all your risks to the Risk Manager.
2. Before adding new risks, check or customize your risk matrix/model according to your severity and probability levels, and assign the risk class values in the matrix cells based on your risk acceptability levels.
3. You can navigate between the table, matrix/model and reports view by using the left panel options: “Risk Management” (the table), “Risk Matrix”/“Risk Model” (initial and residual risk matrices) and “Reports” (Risk Management Plan and Risk Management Report).
4. Enter your product risks and the related information in the risk management table by filling in the table cells or by copying (“clone” in the floating menu) the already existing risks.
5. Link mitigation actions and verification actions by starting to type the Jira issue number or summary into the corresponding cells, and then selecting the correct issue.
6. Customize the table (add, move, remove, hide, edit columns) according to your needs by hovering over the table headers and selecting the options required.
7. Filter, sort and/or export the table content as needed.
Risk Manager is built to keep your data safe and secure. Each action is secured by a specific permission/project role. Before making any changes to a risk project, please review the setup of your risk project security/permissions. You can find required permissions explained in greater detail at Risk Manager Security.
To manage risks you first need to create a special type of project in Jira. This can be done only by using the “New Risk Management project” menu item either from the Risk Manager drop-down menu in the Server version or under the Apps drop-down menu by selecting the Risk Manager and clicking “Create a new Risk Project” button in the Cloud version.
The SoftComply Risk Manager knows whether it is a risk management project or another type of project you have created to your Jira instance. Only risk management projects can have access to the features of the SoftComply Risk Manager. In other words, in order to manage your product risks you first need to create a new risk management project.
After starting the risk management project from the Risk Manager wizard → Create “New Risk Management Project”, follow these steps:
1. The first step requires you to enter the project name, the project key and the project lead. These fields are Jira standard fields that are always required when creating a new project.
Regarding the “Inherit Permission, Notification and Issue Security Level Scheme from the following Risk Project” checkbox in the Cloud version of the SoftComply Risk Manager: If you have a specific project configuration set up in an earlier project, you can inherit those schemes by checking the checkbox and selecting the suitable earlier project. It can make your Jira administrator’s life much easier and you can use the same configuration in your next risk management projects as well! You can inherit only permission, notification and issue security schemes but not the entire configurations. There are some restrictions in Jira Cloud, thus you cannot inherit workflow schemes, screen schemes or anything else that is not listed as inheritable.
If you do not choose to inherit any configuration, the default ones will be used. After project creation you should configure your project according to your needs by following Jira administration guide.
2. The second step in the wizard is the selection of a risk matrix layout. There are several of the most frequently used matrix layouts to choose from, as a starting point. You can, if you need to, customize your risk matrix after you have finished the project creation. But to accelerate your risk management project setup, choose a matrix layout that is as close to your needs as possible to minimize customization effort later on.
3. Last step of creating a new risk management project is the selection of a risk management table template. Various templates are proposed with different table layouts (columns). You can customize the table layout after finishing your project creation. During customization you can Add/Remove columns, Hide, Move and Edit column names (all columns).
You can also enable the sample data to be included in your new risk project for demo purposes that you can remove later on. This option is disabled by default.
Finally, there is an option to “Enable strict Harm and Severity mapping”. This feature is related to the requirement of ISO 14971 for medical device risk management where one harm is always having the same Severity throughout one risk project (the mapping is enabled by default). In case you update the Severity of a risk, the SoftComply Risk Manager app will check all the risks in the risk project that have the same Harm and it will then update their Severity as well to keep the risk data consistent. In case you would like to use the SoftComply Risk Manager to manage other types of risks (e.g. project risks, cybersecurity risks, etc) where you’d like to have different Severity levels for risks that have the same Harm, then you can disable this mapping when you create the new risk project. Note that this feature can only be changed when creating the risk project and cannot be modified later.
Be aware that the mandatory columns of Risk Summary, Harm, Severity (Initial and Residual) or Probability (Initial and Residual) cannot be deleted from the risk management table. You will be able to create several different types of new columns including Select, MultiSelect, Issue Link, and other types of columns. It is best to choose a table template that is closest to your needs and configure the rest of the table as you work on the risk assessment.
To configure risk matrices, go to the “Risk Model” view in the Server version of the Risk Manager or the “Risk Matrix” view in the Cloud version of the Risk Manager. In order to modify risk model you need Risk Manager Administrator project role (server/data center) or Project Administration permission (cloud). Please read more about permissions at Risk Manager Security.
Risk matrices are fully configurable. You can:
a) Add/Remove Severity Levels and their descriptions;
b) Add/Remove Probability Levels and their descriptions;
c) Add/Remove Risk Class values;
d) Change Risk Class values in the matrix.
Take a look at the short video tutorial below for Risk Matrix customization options:
To access the previously mentioned actions just hover over severity, probability or risk class fields and you will see the floating menu with action buttons. Be aware that if you remove a severity or a probability value, the risks that had the value assigned to them will automatically get the value of “unassigned”. Be sure to re-evaluate those risks later on.
Better yet, configure your matrix first before you start adding risks in the risk management table!
Configuring the risk table is the most important part of setting up your risk management project properly. Since each person responsible for risk management has their own way to approach risk management, it is best to use the risk terminology that is accepted and used in your company. The predefined templates are also a good option to start with if you have not yet created your own tailored approach. The columns/terms that are used in the Hazard Analysis template and in the FMEA template are from ISO 14971 and IEC 60812, respectively. We recommend to use one of our out-of-the-box templates, especially when you are working in a medical domain.
Below is a short video tutorial on SoftComply Risk Manager table customization options:
In order to change the table layout you have the following options:
1. Rename the column names and descriptions.
This applies to all columns;
2. Add/Remove new columns.
You can create various different types of columns. In the Server version of the Risk Manager, you can create the following types: Textarea, Number, Date, Select, Multi Select, User, Version, Issue Link, Custom Field, and Component. In the Cloud version of the Risk Manager, you can create Textarea, Select, Multi Select, Jira Issue Field, Issue Link and Text type columns.
Note!: You cannot delete the mandatory columns of Risk Summary, Harm, Severity (Initial and Residual) or Probability (Initial and Residual);
3. Hide columns.
All columns can be hidden to give a better overview of the table according to your needs.
4. Change the column order.
You can change the order of the columns in your risk management table by clicking on the right/left arrows in the floating menu that appear when you hover over the column header.
5. Resize the column width.
You can easily resize the width of each column by dragging the triangles on the headers of each column to expand or decrease the column width.
6. Sort the data by a column of your own choosing.
Users can disable automatic sorting of data (default setting) and choose a column to sort the data in the table themselves – sort the data.
You can access those actions by clicking on the menu that opens while hovering over the table header:
The SoftComply Risk Manager is a tool to make risk management process easy to implement in your organization. Risk management is done by simply managing your risks in a table. Adding, removing, and linking risks to provide full traceability is now easier than ever!
The main tool for working on your risks is the risk management table. In the following sections you will learn how to get most out of its features.
There are three ways in which you can add new risks to the risk table:
1. Manually add risks by selecting “+ Add Risk” from the Header of the Risk Table view; or
2. Clone risks from previous row; or
3. Import risks from another system or project.
To manually add new risks click on “+ Add Risk” button above the table. This creates a top row to the risk table with empty values. Fill in the necessary values and click “Confirm” on the floating menu or press “Enter” on keyboard to save the risk.
Note! In order to add new risks the only mandatory field is “Hazard”. All other fields can be left empty if you are not yet sure what to enter there.
Risk Cloning is a useful feature if you have more than one risk with the same Hazard, Hazardous Situation, or other. Often one Hazard can occur in different Hazardous Situations and can thereafter cause different Harms. It is therefore quite convenient to copy all the values up to a certain point (certain cell in the row) for similar risks and fill in the rest of the fields that may be different.
In order to do this, use the “Clone” feature. You can access the “Clone” feature from the floating menu. Be aware that it is important to select the “Clone” feature from the correct cell – the cell where you choose the “Clone” feature will be the last of the copied cells in the new risk management row that is created!
To edit a risk in the table, you have two options:
1. First, by clicking a row that you would like to edit, makes the risk editable. Another click somewhere else in a table saves the changes you made and makes another risk (row) editable. If you have finished making changes, select “Confirm” on the floating menu;
2. Second, by selecting “Edit” action from the floating menu.
You can also use keyboard shortcuts in the risk management table: to edit a risk, click on the cell you wish to edit. To save entered text in a cell, press “Enter”; to delete entered text in a cell that you added, press “Escape”. For saving a selected “Severity” or “Probability”, double-click “Enter” after selecting the desired level.
To delete or remove a risk from the table, select the correct risk from the table by hovering on it with a cursor. Then click on the “Delete” button of the floating menu. The risk itself will not be deleted! It will be changed from “Open” status of Jira issue workflow to the “Done” state. This provides you with an option to undo the delete action by opening the Jira issue view and manually changing the issue status back to “Open”.
In addition to manually entering risks to a table, you can also import risks from another system. If you have not yet added any risks to your project, then quick links to risk/issue import are available. If you choose to import risks from other systems (e.g. csv file, excel, other issue management systems) follow the instructions for this that Jira provides. You can also follow our detailed guidelines to import your existing risks to the SoftComply Risk Manager.
Assignment of risk classes (e.g. High, Medium, Low, TBD) is done automatically according to the risk matrix configuration after you have defined the values of severity and probability of the risk under assessment. The risk class of each risk under investigation will be assigned automatically based on the value of severity and probability of that risk. Risk classes are defined in the risk matrix. Risk class cannot be assigned automatically to risks in the risk table before you have defined the risk classes by setting the values of severity and probability in the risk matrix/model view. Until that time, the value of a risk class will remain “TBD” (To Be Determined).
According to the risk management process described in ISO14971, each risk has two values of risk class assigned: initial risk class, and the final (residual) risk class after the mitigation has been completed. This is why there are two values of severity and probability and two values of risk class columns on the risk management table corresponding to the initial and the residual risks.
The first column of the risk management table is called “Risk” and it provides a visual indicator of the initial and residual risk class values. E.g. if your initial risk class was High and you mitigated it to Low, then you should see a Red dot and a Green dot. This field provides a quick visualization of the risk mitigation results. The uncoloured dot depicts a risk to which a risk class has not yet been assigned.
Risk mitigation can be done by assigning mitigation actions to your risks. The mitigation actions can be activities or procedures that mitigate the risk and lower the risk class. There are 2 columns that describe mitigation actions:
1. Mitigation Action (free text field), and
2. Mitigation Links (link to another (external) issue/software item).
Mitigation actions can be defined either by entering a description to the column “Mitigation Action” or by linking another issue to the risk in the columns “Mitigation Links”. Mitigation actions can be issues from other projects and you can link requirements or other development issues to the risk under mitigation. To link issues, start typing either an Issue key or Summary of the issue you would like to link to. The autocomplete text field will suggest you the issues it finds based on the text that you entered.
NB!: The recommended use of mitigation actions is as follows:
1. There should be at least 2 separate projects: one for the risk management and another where you manage your product development issues like development tasks, requirements and alike that might be used for risk mitigation.
2. Link the mitigation action from the development project to your risk via “Mitigation Links” column.
If you have no mitigation action defined yet, but you would like to create it during risk management project, then use “+” button in the Mitigation Links column. This will open a “Create new issue” popup window in Jira and you can create a new mitigation action to any project you have access to.
After creating an issue by using this feature, the SoftComply Risk Manager automatically adds a link between the issue you created and the risk you were processing at that moment. Thus, you can add new risk mitigation actions and move on with your risk management without having to leave your risk project view.
NB!: In the risk management table you can see the mitigation action issue key, issue summary and issue status. This provides you with an easy way to assess at a glance if actions are done, in progress, or still on the to do list.
Verifying mitigation actions is similar to mitigating risks with regard to the features of the SoftComply Risk Manager. There is always an option to add verification actions manually as a free text to column called “Verification Action” and linking the verification actions to the risk mitigation action (to verify that the risk mitigation action works as intended).
Linking verification actions (e.g. testing activities from another Jira project) is similar to linking mitigation actions. It is best to start by typing the issue key or summary to autocomplete the text field and then pick the issue from the drop-down list of suggested issues.
By clicking on a “+” button on the right side of the “Verification Action” column, it is possible to create a new verification action in the risk management project. The created verification action will then automatically be linked to the risk.
NB!: In the risk management table you can see the verification action issue key, the issue summary and the issue status. This provides you with an easy way to assess if the verification actions are done, in progress, or still on the to do list.
After mitigating risks, the final risk assessment should be conducted by assigning final severity and probability values. Thereafter, the final risk class will be assigned and it is possible to see the residual risks. To see the initial and the residual risks click on the “Risk Matrix”/”Risk Model” icon on the left menu and open the Risk Matrix view.
In this view there are two risk matrices: the initial and the residual one. The matrices can be exported or printed by selecting the suitable action from the top-right corner of the page. It is possible to export the matrices to PDF, DOCX and PNG format. After exporting the matrices, you can save the file as a snapshot of that moment in time.
It is also easy to visualize the effectiveness of your risk mitigation actions by looking at the first column of your risk management table. The coloured dots depict the values of the initial and the residual risk class of each risk. In a perfect world you wish to see primarily green dots on the right of the small arrow.
The SoftComply Risk Manager provides two report templates (Risk Management Plan and Risk Management Report) in addition to the export feature for both the risk management table and the matrices.
The Risk Management Plan is based on the requirements of ISO 14971 giving an overview of all the planned activities of risk management. The Risk Management Report is a document that describes the results of the Risk Management activities. Both reports can be accessed either from the Risk Manager drop down menu or from the “Reports” section of Jira sidebar.
Both the Risk Management Plan and the Risk Management Report include guidelines on how to fill in your project specific data. The Risk Management Plan automatically includes the data that you defined at the start of your risk management project, including the risk classes and their acceptance criteria; risk matrix configuration; the severity; and the probability values. The Risk Management Report automatically includes the initial and the residual risk matrices.
The SoftComply Risk Manager security and permission related configuration is explained at Risk Manager Security.
The risk management table has 3 columns for links to other issues:
1. Mitigation Links;
2. Verification Links;
The “Mitigation Links” and the “Verification Links” columns can be used to assign a link of an issue (mitigation action or verification action) to each risk or to create a link to a new issue (new mitigation action or new verification action).
The “Traceability” column provides an overview of all the links that are connected to a risk, including the links to other risks that the mitigation action(s) may have introduced.
You can also create new Issue Link type columns in the risk management table for additional relationships you may want to describe between risks and other issues.
The “Traceability” column then provides an overview of all the links between a risk and other issues including the “Mitigation Links” and the “Verification Links”.
In the “Traceability” column you can see all the links related to one risk, including the following Risk Manager link types:
a. “is mitigated by” – link type describes connection between a mitigation action and a risk, e.g. risk is mitigated by some software development project issue;
b. “is verified by” – link type describes connection between a verification action and a mitigation action, e.g. a mitigation action is verified by some verification action or test case;
c. “is caused by” – link type describes that this Hazard has been caused by another issue, e.g. some mitigation actions can cause new hazards to appear in the project;
d. all other available Jira link types that can be used as needed, e.g. link types like “is blocked” , “duplicate” , etc.
You can create a new mitigation action or a verification issue while describing a new risk. To do that, just use “+” button on the right edge of the “Mitigation Links” or the “Verification Links” column in edit mode.
Clicking the “+” button will open a “Create new issue” window. After submitting the new issue, the link between issue and risk will be automatically added and it will be visible in the table as well. This feature supports managing risks and posting new issues to other projects at the same time from the risk project.
The content of the risk management table can be filtered to allow an overview of any particular set of data. Each column that allows filtering has a small filter icon just below the column title.
If the filter is applied, a corresponding icon becomes visible. To remove the filter, just click on the remove filter icon.
NB!: If you apply filters and then export the risk management table content, only the visible content will be exported. In case you want to export the entire table content, remove all the filters first.
The risk management table can be customized as follows:
1. Rename column titles that were assigned by the template;
2. Add or remove columns (Note!: You cannot delete the mandatory columns of Risk Summary, Harm, Severity (Initial and Residual) or Probability (Initial and Residual));
3. Hide any column;
4. Sort the data in the table.
All actions that were described above can be performed by hovering the cursor over the table header and selecting the required action from the floating menu.
Users can add the following types of new columns to the Risk Management Table in the Server version of the Risk Manager:
- Multi Select,
- Issue Link,
- Custom Field, and
Users can add the following types of new columns to the Risk Management Table in the Cloud version of the Risk Manager:
- Jira issue field (e.g. due date, assignee, reporter, description, etc)
- Multi Select,
- Issue Link.
Textarea stands for longer than 225-character texts that you may want to add as description to your risks. To save the text you are writing in the textarea cells, please use the confirm button from the floating menu as the keyboard “Enter” will not work in this field type.
Numbers can be used for additional data and calculations you may want to add to your risk data. Only numbers can be entered to this field and you will be able to use “Enter” on your keyboard to save the number.
Date can be used to describe the time risk was entered, mitigated, verified or approved. You can then sort your risks based on these dates if needed.
Select column type enables listing several options users can select from when adding information into the table. You will only be able to choose one option at a time. For example, you may want to add the type of risk based on which subsystem it is affecting, e.g. Software or Hardware, etc.
Multi select column type supports listing several options users can select from and here you can choose several options at once. For example, you may want to add the various components that the risk is affecting, e.g. interface, calculator, algorithm, etc.
User column type enables adding any person from your organization (has to be Jira user) to any risk, e.g. a person who created the risk, a person who reviewed the risk or assigned mitigation action, etc.
Version column type allows you to link your risks to a specific software or project release (i.e. Jira fixVersion field). Jira fixVersions field is used to track time-based milestones in a project and organize releases.
Issue Link column type allows you to add new link type columns to the Risk Management Table. You can also map any existing link type to the Risk Management Table similarily to the already provided Mitigation and Verification link columns. For example, you may want to use a link type “Is Blocked by” in the new link type column to illustrate that some development tasks are blocked by certain risks. You can now have all these links visible in the Risk Management Table as well as traceable since they are also visible in the Traceability column of the table.
Custom field column type allows mapping an existing Jira custom field to the Risk Management Table. For example, if you have a “Responsible” field (type User picker) in Jira customfields already and it is used in various projects, then you do not have to create it again. You can simply select this existing field and map it to the Risk Management Table. Having fewer custom fields in your system will increase your Jira performance and support a more flexible Jira configuration.
Component column allows you to link your risks to a specific Jira Component (Jira project specific components on Component field). According to Atlassian, Jira project components are generic containers for issues. Components can have Component Leads: people who are automatically assigned issues with that component. Components add more structure to projects, breaking it into features, teams, modules, subprojects, and more.
In order to map a Component, you have to choose “Jira issue field” type for your new column and select “Component” as the Jira Issue Field as shown in the figure below:
The risk management matrix can be customized as follows:
1. Edit Severity or Probability values.
1.1. Add a new value;
1.2. Edit the existing value name and description;
1.3. Remove a value.
2. Add or Remove Risk Classes
2.1. Add a new Risk Class;
2.2. Edit the name of a Risk Class;
2.3. Remove a Risk Class.
3. Assign risk classes to specific Severity-Probability combination in the Risk Matrix
3.1. Each cell in the Risk Matrix must have a Risk Class value assigned to it.
All the listed actions can be found in the floating menus that appear if the cursor is hovered over the Severity or Probability values in the matrix.
In order to demonstrate a compliant risk management process, you may have to report the risks as required by regulations. The following risk reports are provided by the SoftComply Risk Manager:
1. Risk Management Plan, and
2. Risk Management Report.
Reports can be accessed from the top navigation bar menu item “Risk Manager” → “Risk Management Plan” or “Risk Management Report”. They are also available from the “Reports” section of Jira left sidebar.
Both reports are pre-filled templates with guidelines and available data configuration or risk project data contained in them. You can export these reports and edit their content as needed in your organization.
NB!: The blue coloured text provides the guidelines and should be removed from the final version of your document. The square brackets [ ] display the suggested content that you should input. The red coloured text provides you with additional information in the case where you want to comply with IEC 62304 requirements.
NB!: Reports are project specific.
To import existing risks into the SoftComply Risk Manager, please follow the importing guidelines.
In the SoftComply Risk Manager each row of the risk table is a separate issue in the project. Thus, if you import new risks by using Jira import features, this constraint should be considered.
During import, please note one important aspect – the Summary field in Jira is mandatory. If you enter a new risk manually to the risk management table, then the ‘Summary’ field will be the same as the ‘Hazard’. If you choose to import, you can import any value to the ‘Summary’ field, but it will not be displayed in the table. In order to successfully import your data to the table, please import ‘Hazard’ value to the ‘Summary’ field and also to the ‘Hazard’ field.
The risk management table is sorted automatically by default. The sorting algorithm starts from the “Hazard” column, which it sorts alphabetically. Next, each hazard value is sorted alphabetically based on the “Hazardous Situation”. Thereafter, each “Hazardous Situation” is sorted by the “Harm” and so on. This provides an easy to read structure to the risk management table. Identical content in subsequent rows is displayed in light grey, indicating grouped items. This approach hides repetitive information and emphasizes the unique information. In order to limit the number of rows in the table, you can always use filtering.
User-enabled Sorting of the Data in the Risk Management Table
User can also disable the automatic sorting in case they wish to sort the data by a column of their own choosing instead. User-enabled sorting is a project specific feature, i.e. user will have to enable it in each risk project.
To enable sorting, please go to project settings in the bottom left corner of your screen and you will find “Risk Manager” at the bottom of the sidebar that opens up a Risk Manager Settings page.
To enable sorting by a column of user’s choice, please check the “Enable Sorting” button:
After saving this setting, the user will be able to choose a column of their own liking that will be used for sorting the data in the Risk Management table.
By clicking the arrow pointing upwards, the data will be sorted in ascending order in the chosen column while clicking on the arrow pointing downwards, sorts the data in descending order in the chosen column.
Linking Harm with the Severity of the Harm is a feature of the SoftComply Risk Manager app that is enabled by default when you select the Hazard Analysis and/or FMEA template in the New Risk Project Creation wizard.
This feature is related to the requirement of ISO 14971 for medical device risk management where one harm is always having the same Severity throughout one risk project.
In case you update the Severity of a risk, the SoftComply Risk Manager app will check all the risks in the risk project that have the same Harm and it will then update their Severity value to keep the risk data consistent.
This features is enabled by default when you create a risk project – on the last screen of the New Risk Project Creation wizard there is an option to “Enable strict Harm and Severity mapping”.
In case you would like to use the SoftComply Risk Manager to manage other types of risks (e.g. project risks, cybersecurity risks, etc) where you’d like to have different Severity levels for risks that have the same Harm, then you can disable this mapping when you create a new risk project. Note that this feature can only be changed when creating the risk project and cannot be modified later.
Each market sector has its own rules and best practices for risk management. The SoftComply Risk Manager is based on the ISO 14971 – risk management standard for Medical Devices.
Regardless of the sector you are in, the approach described in ISO 14971 can be applied to most safety critical domain. In addition, the SoftComply Risk Manager provides many customization possibilities to enable users to modify the risk management table to other safety critical domains and risk assessment approaches.
Typically there are two approaches to risk management: “bottom-up” and “top-down”, generally referred to as “xFMEA”/”xFMECA” and “Hazard Analysis”, respectively. They are intended to be complementary, not exclusive.
Using both approaches increases the probability that you will capture all potential risks associated to your system. It is important to remember that the different approaches need to be aligned and consistent, e.g. the same harm should have the same severity level, etc.
“FMEA” stands for Failure Mode and Effects Analysis. The “x” is a placeholder that is replaced by a letter that indicates the area of the product the FMEA is applied to, e.g. DFMEA for Design, PFMEA for Process (manufacturing process), HFMEA for Human Factors, etc.
The “bottom-up” approach refers to the fact that typically on the left side of the table, where the analysis starts, you list components and sub-components of your system, what their function is and how they can fail.
Example: your system contains a bolt; its function is to keep two components together. The “failure mode” of this bolt is that it fails to keep these two components together; the two components can become loose or even fall apart. The effect will depend on the actual purpose of your device. The cause could be that the bolt is under designed or that it is not tightened, or other causes. Risk mitigation actions could be to use a safety factor when you design your bolt and/or to define a minimum tightening torque during assembly.
Hazard Analysis is a “top-down” approach, meaning that you start (on the left side of the table) with high level, system wide hazards that can be posed by your device. ISO 14971 provides a list of example Hazards that you can use as a starting point. You can also perform a functional analysis of your device and determine how it can fail to provide its functions.
Example: pick “Heat”. The Hazard is that some surfaces of your device can overheat (or in case they can get too cold then freezing is the hazard). One Hazardous Situation is that someone can get in contact with these surfaces, resulting in burns (harm) of different severity. Potential causes could be that some internal electrical or mechanical components overheat. Risk mitigation actions will depend on the actual architecture of the system.
We recommend having separate projects for software development and risk management. If necessary there can be a separate project also for verification activities and testing.
The following set up allows your risk management table to be used to group mitigation actions from the development project(s) and verification actions from the verification projects. Different actions that link to risks provide the necessary division and flexibility in the projects and in the reporting that you may need later. If you prefer to group all issues from different projects together, use JIRA Agile boards or queries.
For tracking the changes in risk management overtime, you may want to take a snapshot of risks at any given time and store that snapshot before continuing with managing or mitigating the risks.
There are different ways you can achieve this. The quickest and easiest way is to export the entire risk management table in pdf format and store it as a snapshot of the status of risks in a certain moment of time.
Another option is to manually do the risk versioning but that requires additional effort. You can learn more about it here.
It is also possible to get a full audit trail of the Risk project and its risks from Jira by exporting issues and their Activity Logs. Follow the Jira documentation to do this.
It is possible to import new risks to risk projects from other systems. If you have not yet added any issue to your project, then quick links to risk/issue import are available. If you choose to import risks from other systems (e.g. csv file, excel, other issue management systems), please follow the instructions outlined here.