Configuring Recurrence Check (QMS)

The Vault QMS Recurrence Check feature is an intelligent and streamlined interface for users to determine whether an event, such as a Quality Event or Complaint is a recurrence of another event. With this feature configured, Vault can simplify a complex manual process with a simple user or entry action where text search terms are automatically suggested by Vault. When executed, the user is shown a set of potential records along with their similarity score in a side-by-side comparison user interface. When the analysis is complete, Vault stores the results and automatically links recurrent events by creating applicable related event records, depending on your configuration. If configured, Vault may also provide insights following recurrence check completion to advise next steps according to your organization’s processes.

The Recurrence Check feature supports standard and custom object types on the Complaint object and all object types on the Quality Event object, as well as the Change Control, Change Plan, Deviation, Finding, Lab Investigation, Continuous Improvement, Nonconformance, and MedTech CAPA objects.

The configuration steps for those objects and object types is described below, and the objects are collectively referred to as the “supported object” in this article.

Configuration Overview

Complete the following steps to enable the Recurrence Check feature:

Configuring the Run Quality Record Check User Action for Recurrence

In order for users to have access to recurrence check functionality at the appropriate stage in the supported object’s lifecycle, you must make the Run Quality Record Check user action available in that lifecycle state:

  1. Navigate to Admin > Configuration > Object Lifecycles and click into the supported object lifecycle.
  2. In the States section, click into the lifecycle state in which you want users to run their recurrence check. For example, select the Closed state to allow users to check for recurrence after the Quality Event has been finalized.
  3. In the User Actions section, click Edit.
  4. Click Create Rule.
  5. If configuring the action for a Quality Event object type, select Perform with Conditions, and select Quality Event Type > equals > [object type].
  6. Select Run Quality Record Check from the Allow the following actions drop-down.
  7. Select an appropriate Quality Record Check from the Available Quality Record Checks drop-down. See below for Quality Record Check configuration instructions.
  8. Select the Allow user to override discovered match terms checkbox to allow modification of search terms in a pop-up dialog after the user performs the action.
  9. Add an Action Label for the action.
  10. Click Save.

Configuring the Run Quality Record Check Entry Action for Recurrence

In order for the recurrence check functionality to execute at the appropriate stage in the supported object’s lifecycle, you must make the Run Quality Record Check entry action available in that lifecycle state:

  1. Navigate to Admin > Configuration > Object Lifecycles and click into the supported object lifecycle.
  2. In the States section, click into the lifecycle state in which you want the recurrence check to be executed as an entry action. For example, select the Define Team state to allow Vault to check for recurrence after the Quality Event has been created.
  3. In the Entry Actions section, click Edit.
  4. Click Create Entry Action.
  5. Choose whether the entry action rule will Always apply or should only Perform with conditions. See details for defining conditions.
  6. If configuring the action for a Quality Event object type, select Perform with Conditions, and select Quality Event Type > equals > [object type].
  7. Select Run Quality Record Check from the Allow the following actions drop-down.
  8. Select an appropriate Quality Record Check from the Available Quality Record Checks drop-down. See below for Quality Record Check configuration instructions.
  9. Select the Allow user to override discovered match terms checkbox to allow a user to modify search terms upon initiating a refresh. Vault ignores this setting initially when executing the entry action.
  10. Select a role from the Inherit Owner from Following Lifecycle Role dropdown. The user(s) assigned this role will become the owner of the Record Check Result once the entry action is executed. You cannot select Viewers as a role to inherit ownership of the Record Check Result.
  11. Click Save.

Creating Quality Record Checks for Recurrence

You can create Quality Record Check configurations for each scenario in which users will need to check for recurrences. For example, if your quality system requires that a newly completed Deviation be checked against older Deviations for recurrence for either six months or one year, depending on the affected process, you can create two Quality Record Check configurations appropriately, both available to users as a separate user action.

To create Quality Record Check configurations for recurrence:

  1. Navigate to Admin > Configuration > Quality Record Checks.
  2. Click Create.
  3. Enter a Label.
  4. In the Date comparison field drop-down, select a date field from the supported object from which to base your timeframe.
  5. In the Date comparison timeframe drop-downs, select a number and time period unit. For example, to include records up to one year previous to the value in the date field selected above, select 1 and Years.
  6. In the Fields on object that must match field, select one or more fields on the object that must match exactly between the records to be included in the recurrence check. For example, if your processes require you to check for recurrences only affecting the same facility, select the Owning Facility field to exclude records for other facilities.
  7. Optional: If you want to limit the check to evaluate object records with a certain lifecycle state, select those states in the Lifecycle states to include drop-down.
  8. In the Fields on object to compare in text search field, select text fields on which to run the recurrence check. When a user performs the action on a record, these are the fields for which Vault provides a percentage match score. If you are configuring a Complaint or MedTech Complaint recurrence check, this field is optional, however, you must populate this field and select the Enable Comparison Settings checkbox to make the Comparison Settings section visible.
  9. Optional: In the Related Object Match Criteria section, select fields on objects referenced by supported object records with which to further limit the records included in the check. For example, if your originating Deviation has Root Cause Category values of Materials, Labelling, and Tooling, you can define match criteria to only include Deviation records where the Root Cause Category on related Root Cause records includes at least one of those categories. Vault displays these criteria to the user when they perform the recurrence check action.
  10. Optional: In the Quality Record Check Insight section, select the Gather Record Check Insights checkbox to enable insights for this particular check. Select an existing Quality Record Check Insight Configuration from the drop-down if you’ve previously configured a Recurrence Check Insights page.
  11. Fill in the Comparison Settings section. This section is visible and required if you are creating a Quality Record Check for a Complaint or MedTech Complaint and the Enable Comparison Settings checkbox is enabled.
  12. Click Save.

Comparison Settings

Perform these additional steps to configure Comparison Settings for a Quality Record Check:

  1. In the Comparison Settings section, define three tiers of match similarity to assist users in analyzing potential recurrences. If you select the Display checkbox, when a user performs the recurrence check user action, Vault displays the tier as a category at the top of the page.
  2. Select a % minimum similarity score from the drop-down for each tier.
  3. Optional: For each tier, selecting the Relationship type required checkbox requires users to provide a relationship type when analyzing each record of that tier. For example, you might require that users select a relationship only for the most likely matches. If you select this option, you can further require users to provide a justification by selecting the Justification required checkbox.
  4. In the Quality Relationship Automation drop-down, select the relationship configuration applicable to your recurrence check, then select the Relationship types applicable to the Deviation being checked.
  5. Optional: In the Fields to Display section, you can choose fields from the Deviation record to display in the recurrence check interface to assist the user in their analysis. These fields are not included in the match calculation.

Configuring the Generate Document From Report Action for Recurrence

The Generate Document From Report action allows a user to create a document containing recurrence check information directly from a Record Check Result record. The newly generated document is linked from a document reference field on the originating Record Check Result record. In order for users to have access to this function, you must create an appropriate report and make the Generate Document From Report action available to users in the Record Check Result object lifecycle.

Creating a Report for Recurrence Checks

When configuring the Generate Document From Report action, you must select a report type and report view. While you can select any report in your Vault, it is most useful to select a report type which matches Record Check Result details to supported object details for records that have been identified as duplicates in the recurrence check. The report view can further filter the resulting report to records of the appropriate object type.

Configuring the Recurrence Check Insights Page

You can configure the Recurrence Check Insights page to help users make data-driven decisions following a recurrence check of a Deviation, Quality Event, Complaint, or Nonconformance record. You can create multiple configurations for each object and object type your organization requires. Once active, Vault automatically navigates to this page after a user completes a recurrence check.

To configure the Recurrence Check Insights page:

  1. Navigate to Admin > Configuration > Quality Record Check Insights and click Create.
  2. Populate the Label, Description, Status, and Object fields. The following objects are available for retrieving insights: Deviation, Quality Event, Complaint, or Nonconformance.
  3. Select an Object Type from the drop-down.
  4. In the Related Records to Summarize section, click + Add Related Record Summary. You can add up to three (3) related objects to summarize.
  5. Select a Related Object.
  6. Select up to two (2) fields to group by.
  7. Select an Inbound Reference Field. Repeat steps 5-7 for each related object to summarize.
  8. In the Field Suggestions section, select up to three (3) fields from the Field Values to Summarize drop-down. You can only select fields with a type of Object, Picklist, or Boolean.
  9. In the Field Suggestion Tiers section, provide a Minimum Similarity Score (%) for each tier.
  10. In the Fields to Display section, you can choose fields from the source record to display on the Recurrence Check Insights page to assist the user in their analysis.
  11. Click Save.

To enable the insights configuration for use:

  1. Navigate to Admin > Configuration > Quality Record Checks and select the desired Quality Record Check.
  2. Click Edit.
  3. In the Quality Record Check Insight section, select the Gather Record Check Insights checkbox to enable insights for this particular check. Select the Quality Record Check Insight Configuration you just created from the drop-down.
  4. Click Save.

Recurrence Check Limitations

By default, there is a maximum number of records that Vault can include in a recurrence check, which differs by object type:

  • Quality Event object types: Deviations, Change Controls, Proactive Initiatives, External Findings, Internal Findings, Lab Investigations, Nonconformances, and custom object types: 100
  • Quality Event object types: Complaints and MedTech Complaints: 200
  • Complaint object: 200
  • Change Control, Change Plan, Deviation, Finding, Lab Investigation, and Continuous Improvement objects: 100

You must have the following permissions to configure or use Quality Record Checks:

Type Permission Controls
Security Profile Admin: Quality Record Check: Read, Create, Edit, Delete Ability to see, create, and manage Quality Record Check configurations
Security Profile Admin: Quality Relationship Automation: Read Ability to select Quality Relationship Automation values within Quality Record Check configurations
Security Profile Object: Quality Event: [object type]: Read, Edit Ability to view records of this object type in the recurrence check interface and edit fields from the Recurrence Check Insights page
Security Profile Object: Complaint: Read, Edit Ability to view records of this object in the recurrence check interface and edit fields from the Recurrence Check Insights page
Security Profile Object: Change Control: Read Ability to view records of this object in the recurrence check interface
Security Profile Object: Change Plan: Read Ability to view records of this object in the recurrence check interface
Security Profile Object: Deviation: Read, Edit Ability to view records of this object in the recurrence check interface and edit fields from the Recurrence Check Insights page
Security Profile Object: Finding: Read Ability to view records of this object in the recurrence check interface
Security Profile Object: Lab Investigation: Read Ability to view records of this object in the recurrence check interface
Security Profile Object: Continuous Improvement: Read Ability to view records of this object in the recurrence check interface
Security Profile Object: Record Check Result: [object type]: Read, Edit Ability to view and edit Record Check Results and records of this object type
Security Profile Object: Record Check Match Record: [object type]: Read, Edit Ability to view and edit Record Check Match records of this object type
Security Profile Object: Related Record - Summary Data: Read Ability to view data for related records on the Summaries tab of the Recurrence Check Insights page
Security Profile Object: Related Record - Field Summary: Read Ability to view data for related records on the Field Suggestions tab of the Recurrence Check Insights page