In this guide we will dive into the Quality Event process.
Quality Event is a process to manage negative quality incidents and their follow-up investigation and resolution actions.
Please note that this process is based on Simploud’s best practices which were developed from years of experience, however, we can simply update it to align with your business needs.
We recommend working with this guide while having the system open this way you can learn faster and experience it yourself!
Creating a Quality Event
Follow along the instructions and let’s learn how to use the Controlled Document object!
Click on the Quality Event process tab or search the process name from the 9 dots on the left.
Create a New Quality Event record.
Fill in the Title and Type.
Quality Event Workflow
Before we start learning how the process works, it is important to understand that each process has its own flow called “Workflow”.
What is a Workflow?
Each record has its own workflow which displays the record’s current state. In some phases, the record’s owner can assign either a specific user or a group of users, as participants that need to complete certain tasks upon the record. By completing these tasks (using workflow buttons), those participants allow the workflow to move on to the next status. These tasks are also known as “Workflow Tasks” discussed during section: Tasks.
This is the Out of the Box flow of the Quality Event that we will go over:
Identify the Quality Event that occurred.
The Reviewer checks the Quality Event record.
Investigate the event.
In this status a CAPA (Corrective and Preventive Action) is created as a related item (explanation below). The CAPA allows us to think of actions to prevent the event from occurring in the future.
Approve the CAPA plan.
Close the Quality Event record.
Cancel the Quality Event record.
These are all the statuses the record can go through.
These are the workflow buttons that will allow us to move the record between statuses.
The Details tab presents all the fields captured on the record.
There are certain field types such as: text, date, number, picklist (drop- down) and checkbox.
You can see that all the fields here explain the event that happened in order to document all the details in the record.
The fields are presented in the page layout int the Details tab.
Make a change in one of the fields (e.g. Responsible Department). Click Save.
Captures the record’s changes as required by Part 11.
Scroll down and see the change you made captured in the Audit Trail.
Who made the change?
When the changed occurred?
What changed? – old and new value
Files- you can upload a file to the record.
Participants- each status can contain a Participant that is responsible. From here you can define the users.
Tasks- create tasks related to the record (will be explained in the future).
Related Items- You can connect other processes to your record.
*In Quality Event we usually connect CAPA (Corrective and Preventive Action) as a related item.
Prints- allows us to print the record information. We can create several prints for a record.
Attach a File
Quality Review Stage
The Quality Review status is managed by only one participant called Quality Reviewer.
For this reason we will not choose the Quality Reviewer from the Participant component but the field will pop up when clicking on the Submit button.
- You can also add yourself as a reviewer (to maintain flexibility).
Electronic Signature and Comment
- Each button can have an electronic signature or required comment in order to move to the next status.
- You can define a signature for any button (usually we set the login to be the first name of the user).
Let’s move to the Investigation status and see how the electronic signature works:
If an investigation is needed, the event needs to be investigated by an investigator participant.
Move to the CAPA Plan status, provide a summary for the investigation stage.
Creating CAPA as a Related Item
CAPA Plan Approver Participant
To move to this status we need to pick a CAPA Plan Approver Participant.
Because this status allows selecting more than one approver, we will select the approver/s from the participant component.
You can see that the status won’t allow to move before choosing the participant.
CAPA Plan Approval
Great! You finished handling your first Quality Event record.