Process Editor

Processes are a powerful option for QMS Events and Business processes.

QMS Processes essentially are a series of predefined QMS events as defined by the ISO Standard, in particular for ISO 13485 and FDA’s QSR (Quality System of Regulations, sections related to medical devices) or ISO 9001.

The Processes are only available to PTOs and Managers. The Processes are not available in private projects.

The Processes must be approved and set as active before they can be started.

Go to the 'Settings' and choose 'Processes' in the menu on the top of the screen. There is a list of all Processes available in your company, including default and custom Processes. You can view and edit any of them. The Process Editor is split into the chart editor and the toolbar.

Process editor

Chart Editor

The chart editor has the following parts:

Background – it helps the user to organize the steps of the process. It is split into the Project part and the QMS part (project-related and QMS-related Process steps). The background can be resized to fit all the elements of the chart.

 

Chart elements consist of a trigger and an action.
"Trigger" is an operation that will trigger the next action. The trigger can be changing the issue status to "Closed" (or a different status). That will trigger the next action. Action is the step that can be: Create Issue, Attachment Approval, Start Process, Create Join Step or End (to finish process).

  • Create Issue – to create a new issue (Bug, Task, Feature, Meeting, To Do, QMS Event, QMS Decision, Decision, Custom Form),
  • Start Process – to start already created process,
  • Attachment approval – choose the workflow, and Create Decision (Decision is a task where you have to put an attachment that needs to go to approval). Attachment automatically goes on “Pending” status. When all attachments are Approved or Declined (just not Pending status), you can close the task Decision.
  • Create Join Step - You collect more than one task. This is a "station" where the remaining tasks are awaited to continue with the next one.
  • Connect to Join Task – If you already created a Join Task, now you can connect your task with the Join task.
  • Update Issue – involves modifying an existing task. You select the issue you want to change and specify which field needs updating (typically the status field).
  • Recreate Element – means generating a new task based on an existing one. This is particularly useful when modifying an existing process and needing to align or link the steps within that process.
    *Decision cannot be updated but can be recreated.

Issue type:

Most of the issues that you can use in the process are issues available to use separately in the system. There are a few types that can be used only in Process like QMS Event and QMS Decision. Some are explained below: 

  • Decision – This issue is Decision type, without QMS, you can find it in the Project module/issues. Click edit and choose your Decision. If you choose this issue and then choose QMS type from dropdown menu, that issue will appear on both: the Project and QMS modules.
  • QMS Decision – This issue is a QMS Issue and you can find it in QMS module/issues – click Yes or No (approve or decline)
  • QMS Event – that is just a notification that the process is finished. Click Finish to approve that you got the message.

The various shapes and colors represent different Issue types.

Red diamond-shaped elements represent QMS Decisions and QMS Events.

The blue diamonds are Decisions.

The blue semicircle represent Join Step.

Join step

The green rectangles represent any other Issue type.


 

Triggers - the trigger of the next Process step. It could be an Issue update.


 

Start/End - these elements represent the entry point and the endpoint of the process. A Process needs to have at least one route from the start to the end (connected by Triggers).

 

Toolbar

The toolbar will show information about the action and the trigger. It depends on what you select on the chart.

If you select the circle, that is an Action:

Action

Information that you can change is the name of the selected item. If you want to change an issue, choose the "Edit Properties" button. To add a Note with Properties next to the step in the chart view, click "Add Note With Properties"

To change the properties of an action and/or triggers, or to add Sub-task, select rectangle:

Triger and action change

The toolbar will now show more information about the action and trigger.