- Please click on the 'Settings' module in the sidebar, and click on 'Processes' in the menu on the top of the screen. Please note, 'Processes' are only available to the QMS Manager System Role/Group and users with Administrator or Project Manager rights.
- Click on ’+ Create New Process’ in the top-right corner of the Processes page to create a new Process.
- In the ’Create process’ window, type in the name of the new Process, and optionally add a description to it, and select the process category (ISO 13485, ISO 14971, or ISO 9001). Defining process categories can be useful to group processes per area they refer to.
If this process is QMS related then choose QMS Type. Available types are Capa, Nonconformity, Change, Training, and Complaint Management. If your process doesn't fit any of these types, just choose General QMS. All processes with QMS type Capa will be presented on the CAPA Control table (for more, check this link - "Process tab" subtitle).
Note: Business process can be followed up from the Project Management module, in a project where they have been started in a section Started processes.
QMS Processes can be followed up from the QMS Module, in a project where they have been started in a section Processes.
Add at least 2 tags.
Click on the 'Create'.
- The next page is the Process Editor itself. It consists of the chart editor in the center and the toolbar on the left side. Click on the ’Start’ element in the chart editor. Chart elements are highlighted in red when selected.
- Select "Start", and click on 'Add Trigger' in the toolbar on the left.
- In the ’Select an Action’ window, click ’Create Issue', ‘Start process', or 'Attachment Approval'.
- In our example, we are going to create a Task type Issue as the first step of our custom Process.
- In the ’Create New Task’ window, fill out the data fields and click Save.
- The new step of our Process is displayed in the chart editor as a new chart element.
You can adjust the position and also the size of the chart element on the background of the chart editor.
- Click on the input (the 'circle' on the top of the element) of the chart element to view additional information about the chart element in the toolbar on the left, such as Name of selected item, Actions, and Properties sections.
Item indicators (item name), Actions, and Properties are displayed in the toolbar on the left.
To rename the chart element, click on the text field in the 'Selected item' section of the toolbar on the left.
Type in a new subject and press Enter on your keyboard.
Let's rename our element to 'Create Work Instructions'.
Click on the pink rectangle ("Create Work instruction - task") -
In the 'Properties' section, you can edit the data fields of the chart element by clicking on ’Edit Properties’.
When you are done updating the data fields, click Update.
Let's update the Priority of our element to 'High'.
To add a Note to the chart, with the properties of the chart element, click on 'Add Note with Properties'.
- By clicking on the chart element itself, you can also add Trigger to it. A Trigger is a condition of an Issue, which automatically triggers another step in the Process. To add a Trigger to a chart element, please click first on the element in the chart editor. The selected element is then displayed in the toolbar on the left side. Click on ’Add Trigger’ in the toolbar.
- In the ’Add Trigger’ window, please fill out the ’Condition name’ and status.
Triggers are displayed as arrows connecting chart elements, so the Condition name will be displayed as a title next to these arrows. In our example, we are going to give an expressive name to the condition for better transparency of the chart. So let’s name it ’Closed’. It means that when the Task is set to Closed Status, it triggers the next step so the next Issue will be created automatically.
- In the ’Select an Action’ window, you can choose what action the Trigger will take. There are various options: you can finish the Process, you can create a new Issue, start the process or create the Join task. We are going to create another Issue. This means that the Trigger will automatically create another Issue as the next step of the Process.
Note: Using the ‘Create Join Task’ option, issues in a process workflow can be connected when it’s necessary that fulfill these issues initiate the next step in a workflow.
- In the next window, please select an Issue Type. We are going to create a ’QMS Decision’.
- Please fill out the data fields and click Save. We are going to name it 'Approve Work Instructions'.
We are going to select the QMS Manager Group to be assigned to the QMS Decision.
It is important to note that default attachments can be added to new process steps.
By clicking on 'Add attachment', you can copy and attach documents from another folder on the Storage to the folder of the Issue. Then, the document will be used and updated inside the Issue folder. When the Issue is created in the next Process step, a new folder will be created in the Storage with the name of the Issue. An attachment is added automatically from the selected folder to the Issue folder, where the document will be used and updated.
By clicking on the 'Inherit Attachment', you can copy and attach the attachments of another Issue from the Process. When the Issue is created in the next Process step, a new folder will be created in the Storage with the name of the Issue. The whole content of the selected folder will be forwarded to the Issue folder, where the attachments will be used and updated. It is ideal to be used when documents need to be sent to multiple Process steps (e.g. approved, reviewed, or processed by different people in the company).
By clicking on 'Add form template', you can add a form template built using the Form Editor Tool as an attachment. Then, the document will be used and updated from the Issue details page and stored there.
- 'Approve Work Instructions' is displayed in the chart editor as a red diamond-shaped chart element (QMS Decision type Issue). Move it to the QMS section of the chart editor (to the right side of the chart). Diamond-shaped chart elements represent QMS Decisions and Decisions, and rectangle-shaped chart elements represent any other Issue types. Red-colored chart elements represent QMS Decisions and QMS Events, blue chart elements are Decisions, and green chart elements represent any other Issue type.
Please note, that you can adjust the position of the Triggers in the chart to make them more visible.
- Let’s say, if the QMS Decision has been approved, the process will be finished.
To trigger this, please click on the chart element, and click on the ’Add Trigger button in the toolbar on the left side.
- Please define the required conditions for the Trigger. We are going to select ’Status’ and ’Approved’ as required conditions. Click Next.
- In the 'Select An Action' window, we are going to select ’End’ as Action.
- The Trigger is now displayed in the chart. It means, that if the Status of the QMS Decision is updated to 'Approved', the Process is finished automatically.
Now, we have a full path from the Start to the End of the Process.
But what if the QMS Decision is going to be declined instead? We need to define that situation too, to have a proper Process. In this case, we want to jump back to the first step of the Process ('Create Work Instructions') and set it to ’Reopen’ Status. Let’s add a Trigger for that case.
- Click on the 'Approve Work Instructions' chart element, and click on ’Add Trigger’ in the toolbar.
- Fill out the data fields in the next window. We are going to name the Trigger ’Declined’, and select the ’Declined’ Status as a condition.
- In the ’Select an Action’ window, select ’Update Issue’ to update an existing chart element.
- In the ’Select an Element’ window, please select the chart element you want to update. We are going to update ’Create Work Instructions’.
- In the next window, add the data fields of the Issue you want to update. In the ’Conditions’ section, define which new values you want to enter into the data fields.
In our example, we want to jump back to the first step of the Process, and to set its Status to 'Reopened'. Add ’Status’ and select ’Reopened’, then click Update.
- The Trigger is now displayed as an arrow from the second chart element to the first in the chart editor.
- To add sub-tasks to parent elements, click on the 'Add Sub-task' button in the toolbar on the left side. This option allows the user to create sub-tasks of a parent task. The user cannot close the parent task until all sub-tasks are closed.
- Select the Issue type (task) you want to create. Please fill out the data fields in the 'Create issue' window. Click Create.
Our custom Process is now complete. Click ‘Save’ in the top-right corner of Process Editor.
The pop-up window will appear with the information, so you need to click the 'ok' button.
The new Process is now available in the ‘Process’ list and it is ready to be used after is being approved through the appropriate approval workflow.
Process attachment approver step
In processes, there is a step (action) type, called ‘Attachment approval’. This step will inherit attachments from the selected previous steps and starts approval for them.
When this action is selected, the user has to pick an approval workflow that will be used to start approval on the inherited attachments. The step itself is a Decision type issue.
The user has to select the steps to inherit attachments.
The user can select specific steps to inherit from, but they can select all of them if it is needed.
When the process gets to this step, the Decision type issue will be created and approval will be started to all inherited files.
The user can't finish the decision until all files are approved/declined.
