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Quality Events

Introduction

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!

QE
  • 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.

  • Click Save.

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:

For more information about CAPA:
QE
  • 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.

Fields

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.

Audit Trail

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

Right Component

Quality Event
  • 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

Follow along the video and attach a file to the record.

Quality Review Stage

Each status can be managed by one or several users.
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).
 
The record moved to the Review status.
 

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:

Investigation Stage

You can choose whether an investigation is needed or you can skip on this status and move directly to the CAPA Plan status.
If an investigation is needed, the event needs to be investigated by an investigator participant.
Click on Investigation Required and choose the user who will be the investigator.
Sign with your nickname in order to move to the next status.

Move to the CAPA Plan status, provide a summary for the investigation stage.

CAPA Plan

Creating CAPA as a Related Item

In this status, the record owner needs to connect a CAPA record to the Quality Event record.
The CAPA is connected in order to correct the current quality event that occurred and to prevent for other similar events to happen in the future.
You can connect a linked CAPA that already exists or create a new one.
Follow along and connect a new CAPA to the record.

CAPA Plan Approver Participant

Now let’s move to the CAPA Plan Approval status. 
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

The CAPA Plan Approver approves the record and the Quality Event will move to the Closed status.

Great! You finished handling your first Quality Event record.

We recommend learning more about the CAPA process:
Previous Training Management
Next CAPAs
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