Configuring Complaint Intake & Promote to Complaint (QMS)

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. QMS users can continue to create Complaint records directly, but this feature helps streamline the process of receiving, triaging, and creating complaints.

This article explains the Admin setup required to configure the Complaint Intake object and its associated Promote to Complaint action. Once setup is complete, QMS users can create Complaint Intake records and trigger Vault to automatically create a Complaint record from the source Complaint Intake record.

Configuration Overview

Complete the following steps in your Vault to configure this feature:

  • Configure the Complaint Intake object.
  • Configure the Complaint or Quality Event Complaint object.
  • Configure the Reported Product object.
  • Configure the Complaint Contact object.
  • Optional: Configure the Complaint Intake Follow-Up object.
  • Configure the Promote to Complaint action as a user action, entry action, or workflow action on the Complaint Intake object lifecycle.

Configuring Complaint Intake Object

To allow users to utilize Complaint Intake effectively, we recommend the following configuration steps:

  • Activate the MedTech Complaint Intake object type.
  • Activate object fields belonging to the MedTech Complaint Intake object type. In order to create Medtech Complaint records from MedTech Complaint Intake records, ensure all fields required for the Medtech Complaint object type are active on the MedTech Complaint Intake object type.
  • Create a layout for the MedTech Complaint Intake object type and configure it to fit your organization’s business requirements.
  • Configure the Complaint Intake object layouts to display all Complaint or Quality Event Complaint records created from a Complaint Intake record.
  • Configure the Complaint Intake object layouts to display all child Reported Products associated with the Complaint Intake record.
  • Add the special Email Body section or Email Body field to the Complaint Intake object type page layout. The section and field display up to 32,000 characters. If the email content exceeds 32,000 characters, a message displays within the Email Body section in Vault and on downloaded PDFs, while the Email Body field displays a truncated version of the email text in Vault. Users can view and download the full email in the record’s Attachments section.
  • Optional: Add a Complaint Contacts related object section to the layout for all applicable object types. This step is required if your organization uses External Notifications for Complaint Intake records.
  • Optional: If required for your processes, add the following application sections to the layout for the appropriate object type:
    • Complaint Intake Follow-Ups: Allows users to manually record follow-up requests for the Complaint Intake.
    • Follow-Up Attachments: Displays attachments on all related Complaint Intake Follow-Up records.
  • Optional: Create a custom Complaint Intake object tab for users to quickly access and manage Complaint Intake records.
  • Optional: If your process requires translation, configure Quality Automated Language Translations for the Complaint Intake object. When configured, Vault automatically translates field data on a Complaint Intake record at the appropriate step in your organization’s complaint intake process.
  • Configure Quality Teams for the Complaint Intake object.

Configuring Complaint or Quality Event Complaint Object

Make the following changes to the Complaint object or the Complaint object type of Quality Event object:

  • Recommended: Ensure that the Complaint Intake field is displayed on the Complaint object or Quality Event Complaint object layouts.
  • If required for your process, add the following application sections to the layout for the appropriate Complaint object type. To use these sections, the Complaint object must have the Complaint Intake object reference field populated.
    • Complaint Contacts: Displays all Complaint Contacts from the related Complaint Intake record and lets users create new Complaint Contacts.
    • Complaint Intake Follow-Ups: Displays follow-up requests for the related Complaint Intake and lets users create new Complaint Intake Follow-Ups.
    • Follow-Up Attachments: Displays attachments on all Complaint Intake Follow-Up records from the related Complaint Intake record.
  • Optional: If your process requires translation, configure Quality Automated Language Translations for the Complaint object or Quality Event Complaint object. When configured, Vault automatically translates field data on a Complaint record at the appropriate step in your organization’s complaint intake process.

Configuring Reported Product Object

If required for your processes, you can allow users to exclude Reported Products from promoted complaints when the Promote to Complaint action runs. To configure, activate the Do Not Promote Yes/No field on the Reported Product object and add it to the object layout.

Configuring Complaint Contact Object

To configure the Complaint Contact object:

  • Enable the Replicate sharing settings from parent object setting for the Complaint Intake field to allow for role inheritance from the parent Complaint Intake. If the Complaint Intake lifecycle uses custom roles, you must configure a lifecycle for the Complaint Contact object and add the custom roles to the lifecycle.
  • Activate the Email Contact object type to support the creation of Complaint Contacts upon ingestion of a Complaint Intake Follow-Up Email.
  • Optional: To simplify the creation of Complaint Contacts, you can configure Action Triggers to populate Complaint Contact records with values from a selected Master Complaint Contact record.

Configuring Complaint Intake Follow-Up Object

You can optionally use the Complaint Intake Follow-Up object to capture requests for more information about a Complaint Intake. To configure the Complaint Intake Follow-Up object and associated processes, see Configuring Complaint Intake Follow-Up.

Configuring Promote to Complaint Action

The Promote to Complaint action allows Vault to create one or more Complaints related to the source Complaint Intake record. When this action executes, Vault copies active 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. Vault copies fields with matching names, for instance, from Awareness Date (awareness_date__v) on the Complaint Intake object to Awareness Date (awareness_date__v) on the Complaint object. If fields with otherwise identical names but different namespaces exist on the Complaint Intake and Complaint objects (for instance, awareness_date__v and awareness_date__c), Vault may prioritize the last created field rather than the field with a matching namespace.

To configure the Promote to Complaint action: 

  • Configure the Promote to Complaint action on a Complaint Intake object lifecycle state as a user or entry action or a Complaint Intake workflow step. All required fields on the Complaint or Quality Event Complaint object must also be populated on the Complaint Intake and Reported Product records prior to executing the Promote to Complaint action.
  • Select the Object Type of the Complaint record to be created.
  • Optional: Select the Split by Batch checkbox. This setting allows Vault to create multiple Complaints from a single source Complaint Intake and group them by related products and batches. This checkbox is turned off by default.
  • Optional: Select the Copy Attachments checkbox. This setting ensures that Vault copies any supported attachments associated with the Complaint Intake record to all created Complaint or Quality Event Complaint records. This checkbox is turned on by default but is unavailable if the configured Complaint or Quality Event Complaint object does not allow attachments.