The Complaint Intake object allows organizations to intake and triage potential product quality complaints for specific products and their respective batches before an associated Complaint record is created automatically. Vault QMS users can continue to create Complaint records directly, but this feature helps streamline the process of receiving, triaging, and creating complaints.
This feature includes a new Promote to Complaint action for the Complaint Intake object, which allows Vault to create one (1) or more Complaints related to the source Complaint Intake record. When this action executes, Vault copies custom and standard fields from the Complaint Intake to the resulting Complaint records created from this action, including product information and attachments on the Complaint Intake record. The Promote to Complaint action can only be run once per Complaint Intake record; attempting to execute the action multiple times will result in a system error.
To support the Promote to Complaint automation, the objects below are included in the standard Vault QMS data model. These objects support the creation of related standalone Complaint or Quality Event Complaint records.
- Complaint Intake: Represents a potential complaint to be triaged. If necessary, one (1) or more Complaint records can be created and related to the source Complaint Intake record. The number of Complaint records created depends on how an Admin configures the Promote to Complaint action.
- Reported Product: Represents the product associated with a Complaint Intake record. Each Complaint Intake record can have one (1) or more Reported Product records.
- Reported Product Batch: Represents the product batch associated with a Reported Product record. Each Reported Product record can have one (1) or more Reported Product Batch records.
While your Vault may process complaints using either a standalone Complaint object or a Quality Event of a Complaint object type, in this article, these are collectively referred to as Complaints.
Creating Complaint Records With Complaint Intake
Vault can create a Complaint Intake record via an integrated third-party system, such as a manufacturer’s website, or Vault users can create a Complaint Intake record manually. Once a Complaint Intake record is initiated, users can complete a configurable Complaint Intake Assessment process to determine if Vault should automatically generate one (1) or more Complaint records.
The number of Complaint records Vault creates from a Complaint Intake depends on the number of Reported Products and Reported Product Batches and whether an Admin configures the Promote to Complaint action to split by batch.
As outlined in the examples below, if Vault receives a Complaint Intake record that includes one (1) Reported Product and no Reported Product Batches, the Promote to Complaint action creates one (1) Complaint record with the appropriate Product listed. If Vault receives a Complaint Intake record that includes two (2) Reported Products and no Reported Product Batches, the Promote to Complaint action results in the creation of two (2) Complaint records with the appropriate Products listed:
| Complaint Intake Record Received | Complaint Records Created |
|---|---|
| CI-00001 Reported Product: Amoxicillin Tablet 100mg |
COMPLAINT-00001 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 100mg |
| CI-00002 Reported Product: Amoxicillin Tablet 100mg Reported Product: Amoxicillin Tablet 200mg |
COMPLAINT-000002 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 100mg COMPLAINT-000003 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 200mg |
If Vault receives a Complaint Intake record with one (1) Reported Product and two (2) Reported Product Batches and an Admin has configured the action to split by batch, Vault creates two (2) Complaint records, each with the associated Product and Batch records, for example:
| Complaint Intake Record Received | Complaint Records Created |
|---|---|
| CI-00003 Reported Product: Amoxicillin Tablet 250mg Reported Product Batch: Amox 250mg Tab Batch 001 Reported Product Batch: Amox 250mg Tab Batch 002 |
COMPLAINT-000004 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 250mg Batch: Amox 250mg Tab Batch 001 COMPLAINT-000005 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 250mg Batch: Amox 250mg Tab Batch 002 |
If Vault receives a Complaint Intake record with one (1) Reported Product and two (2) Reported Product Batches and an Admin has not configured the action to split by batch, Vault creates one (1) Complaint record with the associated Product and Batch records, for example:
| Complaint Intake Record Received | Complaint Records Created |
|---|---|
| CI-00004 Reported Product: Amoxicillin Tablet 300mg Reported Product Batch: Amox 300mg Tab Batch 111 Reported Product Batch: Amox 300mg Tab Batch 222 |
COMPLAINT-000006 Product: Amoxicillin Tablet Product Variant: Amoxicillin Tablet 300mg Batch: Amox 300mg Tab Batch 111 Batch: Amox 300mg Tab Batch 222 |
Related Permissions
To create and manage Complaint Intake records, users require Read, Create, and Edit permissions for the Complaint Intake or Quality Event Complaint Intake, Reported Product, and Reported Product Batch objects.