Quality Events

The AODocs for Life Sciences Grow package lets you manage CAPAs, Quality Events and Audits. Use the Grow package to enrich and expand your quality management system with automated workflows and processes. Learn more about the AODocs for Life Sciences packages.

There are three types of Quality Event: 

  • Audit Findings
  • Customer Complaints
  • Incidents

They all follow the same workflow.

This article explains how to create Quality Events. You can also find information about the Quality Event workflow and properties.

How do Quality Events integrate with other AODocs for Life Sciences processes?
Create a Quality Event
          New Event
          Investigation
          Investigation review
          Pending CAPA
          CAPA closed
          Event resolved
The Quality Event workflow
Quality Event properties

How do Quality Events integrate with other AODocs for Life Sciences processes?

Customer Complaints and Incidents must be initiated as standalone documents. Audit Findings must be initiated from Audits.

Important: Don’t initiate Customer Complaints or Incidents from Audits. Don’t initiate Audit Findings as standalone documents.

Quality Events are also often related to CAPAs. You can initiate a CAPA from the Investigation and Investigation review states in the Quality Event workflow. Learn more: CAPA: Corrective Action or Preventative Action.


Create a Quality Event

Below is a description of how to create an Audit Finding. Each section corresponds to a different state in the workflow, corresponding to the lifecycle of a Quality Event. Learn more: The Quality Event Workflow.

Most properties are optional throughout the workflow. You can fill in optional properties at any point. A few properties are mandatory during particular workflow states. You can consult the full list of Quality Event properties.

New Event

1. To create a standalone Quality Event (Customer Complaint or Incident): as a member of the Collaborators group, on your library homepage, press New and select a Quality Event type in the drop-down menu:

  • Customer Complaint
  • Incident

Learn more from AODocs: Create documents from a template.

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To create an Audit Finding: with your Audit in the In progress workflow state, scroll down to Related items and create a related Audit Finding. Learn more from AODocs: Create new related items.

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An unsaved Quality Event opens in the New Event workflow state.

The mandatory property Event Type is filled in automatically with the type of Quality Event you selected: Customer Complaint, Incident or Audit Finding. In our example, we created an Audit Finding as a related item from an Audit.

2. Fill in the other property that is mandatory in this workflow state: Event Title.

Learn more from AODocs: Edit custom properties.

3. If required, fill in the Event Date property. Otherwise, leave it blank and it will be filled in with the current date when you save your Quality Event.

4. Save your Quality Event document.

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Note: Customer Complaints and Incidents don’t have to have a related item. Audit Findings must be related to an Audit.

When you save your Quality Event document:

  • it transitions to the Investigation workflow state
  • the Event # property is filled in automatically with a reference number used to populate the title of your Quality Event, along with the Event Title property
  • the Document Owner property is filled in automatically with the email address of the person who created the Quality Event – learn more: Quality Event properties
  • the Event Date property is filled in with the current date unless you defined a different date in the document creation phase
  • in the case of Audit Findings initiated from Audits, the following properties are filled in automatically using property values from the Audit: 
      • Audit ID
      • Audit Team (composed of the Audit Team and Lead Auditor from the Audit)

Tip: Refresh your page if you can’t see all the property values.

Investigation

Your Quality Event is now in the Investigation workflow state. Learn more: The Quality Event Workflow.

While your Quality Event document is in the Investigation workflow state, take the required actions to investigate the issue.

 

Assign Investigators and Reviewers

As a document owner, you may want to assign investigators who report back to you with their analysis. It is also recommended to assign reviewers in preparation of the Investigation review workflow state.

To do this:

1. Press the Edit button.

2. Fill in the Investigators property with one or more investigators.

3. Fill in the Reviewers property with one or more reviewers.

4. Save your Quality Event document.

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Carry out the investigation

During the Investigation workflow state:

  • document owners and investigators have edit access to Quality Events and can add attachments and related items (effective Documents) if required
  • all members of the Audit team property in Audit Findings have read access to the Quality Event document

If Documents with attachments are added as related items, anyone with edit access can copy the attachments from the Documents into the Quality Event. To do this, open the custom action menu and select Copy related document attachments

Note: All attachments from all related Documents are copied. If you run the copy command again, all documents from all documents are copied again, which may create duplicates. 

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Transition the Quality Event

1. When the investigation is complete, as a document owner, press Investigation and select:

Note: Only document owners have access to the workflow button. Investigators can’t transition Quality Events from the Investigation workflow state.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.

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Investigation review

Your Quality Event is now in the Investigation review workflow state. Learn more: The Quality Event Workflow.

Notes:
– At least one reviewer must be defined to transition the Quality Event from the Investigation review workflow state.
– During the investigation review, reviewers can add attachments and related items (effective Documents) if required. In addition, anyone with edit access can copy the attachments from related Documents into the Quality Event

1. As a reviewer, press Investigation review and select:

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.

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Pending CAPA

Your Quality Event is in the Pending CAPA workflow state if you selected Create CAPA in the Investigation or Investigation review workflow state. Learn more: The Quality Event Workflow.

Important: When a Quality Event is in the Pending CAPA workflow state, library administrators can’t force the workflow to a different state. Learn more: Force workflow actions.

1. Scroll down to the Related items section of your Quality Event. You can see that a new CAPA has been created with the same name as your Quality Event. Learn more: CAPA: Corrective Action or Preventative Action.

Note: Your Quality Event can have only one related CAPA. You can’t add another CAPA as a related item.

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In addition, changes are made to these properties in your Quality Event:

  • CAPA Status: switches to Open
  • Escalated to CAPA: filled in with the current date
  • CAPA ID: filled in automatically

Note: CAPA ID is a hidden property, so only library administrators can see it. Learn more: Quality Event properties.

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2. Open your newly created CAPA, which is in the the Routing state. Process your CAPA through to the Closed workflow state. Learn more: The CAPA workflow.

The value of the CAPA Status property in your Quality Event switches to Closed.

Your Quality Event transitions to the CAPA closed workflow state and then immediately to the Event resolved workflow state.

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CAPA closed

Your Quality Event transitions to the CAPA closed workflow state when you close the CAPA that you created in the Investigation or Investigation review workflow state. Learn more: The Quality Event Workflow.

The Quality Event transitions immediately to the Event resolved state.

Event resolved

Your Quality Event is now in the Event resolved workflow state. Learn more: The Quality Event Workflow. The workflow for your Quality Event is complete.


The Quality Event workflow

The workflow below shows the states involved in creating a Quality Event.
Learn more about the properties that need to be filled in at each state.

Quality_Event_workflow.png


Quality Event properties

Below is a list of the properties available throughout the process of creating a Quality Event.

Section Property Description Mandatory at which state in the CAPA workflow?
Top level of list of properties Event #

Incremental reference number that is automatically generated and filled in. It’s used to populate the title of your Quality Event (along with the value of Event Title) when you save it.

Note: If you change its value, it is overwritten with the automatically generated value.

N/A
  Event Title

Fill in a value manually.

Populates the title of your Quality Event document when you save it (along with the value of Event #).

New event
  Event Type Filled in automatically with the type of Quality Event you selected when you created your new Quality Event or related item. N/A
  Severity

You can select from:

  • 1. Minor
  • 2. Medium
  • 3. Major
  • 4. Critical
Always optional
  Event Date

Filled in automatically with the date on which the Quality Event was created.

If required, you can enter a different date manually.

N/A
  CAPA Status

Filled in automatically with one of these values:

  • Not required: you haven’t initiated a CAPA from your Quality Event
  • Open: you initiated a CAPA from your Quality Event and it isn’t yet closed
  • Closed: you initiated a CAPA from your Quality Event and it’s closed

Learn more: CAPA: Corrective Action or Preventative Action.

N/A
  Escalated to CAPA If you initiated a CAPA from the Quality Event (during the Investigation or Investigation review workflow state), this property is filled in automatically with the date you initiated the CAPA. N/A
  Date Closed

If you initiated a CAPA from the Audit Finding (during the Investigation or Investigation review workflow state), this property is filled in automatically with the date you closed the CAPA.

Learn more: Pending CAPA

N/A
  Audit ID

Filled in automatically if you initiate an Audit Finding from an Audit. This property is hidden, so only library administrators can see it. It is also read-only.

Learn more from AODocs: Configure custom property settings.

N/A
  CAPA ID

If you initiated a CAPA from the Quality Event (during the Investigation or Investigation review workflow state), this property is filled in automatically.
This property is hidden, so only library administrators can see it. It is also read-only. 

Learn more from AODocs: Configure custom property settings.

N/A
Personnel Document Owner

Owner of the process.
You can define one or more people.

Filled in automatically with the email of the person who created the Quality Event.

If you enter a different name during the Quality Event creation phase, it is replaced with your name when you save your Quality Event. However, you can choose a different name or add other names once the Quality Event has been created.

Mandatory throughout the process (you can’t save a Quality Event without the Document Owner property filled in)
  Investigators

Fill in manually with one or more people.

Investigators perform an analysis during the Investigation workflow state. They can attach their report to the Quality Event, but they can’t transition the Quality Event to the Investigation review workflow state. A document owner sends the Quality Event for review when they have gathered information from the investigators.

Always optional
  Reviewers

Fill in manually with one or more people.

Reviewers perform the investigation review.

Note: The workflow button becomes available during Investigation workflow state only if at least one reviewer is defined.

Always optional

 

  Audit Team

Filled in automatically when you initiate an Audit Finding from an Audit. It is populated with the values of the Audit Team and Lead Auditor properties from the Audit related to your Audit Finding. This property is read-only.

Note: This property is empty in Customer Complaints and Incidents.

N/A
Summary Event Details Manually enter a description of the event. Always optional
  Impact Analysis Manually enter details of any impact analysis that was carried out. Always optional
  Resolution Manually enter details of how the event was resolved. Always optional

 

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