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.
A business process is a collection of linked tasks which find their end in the delivery of a service or product to a client. A business process has also been defined as a set of activities and tasks that, once completed, will accomplish an organizational goal.
These ISO defined and business processes show the various events, in sequence, that need to be completed to meet the requirements of the ISO Standards or the organization.
As one event in the process is closed, the next is automatically triggered and initiated and this continues until the Process is complete.
The Processes are only available to PTOs and Managers. The Processes are not available in private projects.
The Processes must be approved before they could be used in Project Management Module by an adequate person through appropriate approval workflow.
There are default Processes to ease your work in the beginning. Since every company has its own way of functioning, therefore we created a way to create custom Processes. The Process Editor serves that purpose perfectly. With this feature, you can create custom Processes tailored to the needs of your company.
Please 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.
They are selected by either the project manager or the user and simply dropped into the project at the appropriate point.
In this section, the user has complete overview of all business process that have been started in a certain project.
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 - the various shapes and colors represent different Issues types. Red diamond-shaped elements represent QMS Decisions and QMS Events. The blue diamonds are Decisions, and 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).
The toolbar has the following parts:
- Selected item - it displays the name of the selected element from the chart. You can rename the file on the left side if necessary. Click on the tiny circle on the top of the element to view it.
- Actions – it displays the actual input action that created the selected element, such as 'Create Issue', or 'Update Issue' etc.
- Properties - displays all details about the selected element.
- Triggers - displays the condition that is required to be met to trigger the next step of the Process. Triggers can also be edited or deleted.