Many organizations use Effectiveness Checks, a standard component in QMS Vaults, to track the evaluation of controlled changes in their quality processes. If Effectiveness Checks are a part of your QMS processes, you may wish to automate Effectiveness Check record creation to avoid manual steps and ensure that such checks start when necessary.

Using this feature, you can configure the Create Effectiveness Check record entry action on the QMS application’s Quality Event, CAPA Action, Complaint, Change Control, Change Plan, Deviation, Finding, Lab Investigation, or Continuous Improvement object records to automate the creation and processing of Effectiveness Check records when their related record or, for example, CAPA Action records, enter the chosen state. This entry action is not available to other object lifecycles.

Optional further configuration can automate much of the effectiveness check process, including creation and task assignment, alleviating the need for constant reporting and manual checking to determine the timing and assignment of Effectiveness Checks.

Preparing the Effectiveness Check Object

Before incorporating the Create Effectiveness Check entry action into your object lifecycles, you must ensure that your Effectiveness Check object is ready.

Effectiveness Check Object Types

Depending on the configuration of your Vault, the Effectiveness Check object may have multiple object types. For example, you may have a “QE Effectiveness Check” Effectiveness Check object type for Quality Events, and a “CAPA Effectiveness Check” Effectiveness Check object type for CAPA Action Items. For each Effectiveness Check object type that you wish to create automatically, ensure that their configurations have been properly prepared for use with the entry action.

Required Fields in Effectiveness Checks

An important part of configuration is to consider your use of Long Text and Object Reference fields on the Effectiveness Check object (or object type). The entry action cannot set these types of field values. The entry action will fail if the Effectiveness Check object requires a field to be populated unless it has been defaulted via field defaulting rules, or set using the Effectiveness Check Lifecycle’s Create Record record action’s Set Field action. To populate a field which your process requires, but cannot be set via Field Defaults or the Create Record record action, you can start a workflow on the Effectiveness Check as part of the Create Record record action. Alternatively, if you’re using Quality Teams, you can assign a task to request these field values as part of the Team Completeness destination state entry actions. For example, any Object (User) fields on the Effectiveness Check object (or object type) should be set via a field default rule or configured to be not required, or else the Create Effectiveness Check entry action will fail.

Configuring the Create Effectiveness Check Entry Action

To configure automatic Effectiveness Check record creation:

  1. Navigate to Admin > Configuration > Object Lifecycles and click into your desired lifecycle, such as Quality Event.
  2. In the States section, click into the lifecycle state in which you want to automatically create an Effectiveness Check record, typically a state just after a change has been completed.
  3. In the Entry Actions section, click Edit.
  4. Add the Create Effectiveness Check entry action to the lifecycle state.
  5. Optional: To prevent unnecessary Effectiveness Check record creation, it is recommended that you use the Perform with conditions option in this entry action, selecting the Require Effectiveness Check field (or analogous field, as per your configuration), and defining a condition using equals, and Yes/No per your process.
  6. If you have configured object types for the Effectiveness Check object, select the appropriate type in the Effectiveness Object Type drop-down. The list in the drop-down only includes Effectiveness Check object types with a reference to this lifecycle’s target object. This field will not appear if you have not configured object types for the Effectiveness Check object.
  7. In the Reference field on new Record drop-down, select the field in the Effectiveness Check which will link any newly created record back to the triggering record. For example, the Quality Event.
  8. Click Save.

This entry action will now create an Effectiveness Check when the selected object record enters the selected state. Additional configuration is necessary if you wish to transfer data from the triggering record, to automatically start a workflow for data entry upon creation of the Effectiveness Check record, or to schedule a job for the effectiveness check workflow to start at a later date. See the example configuration below and determine how these configuration options work best for your processes.

Example Effectiveness Check Configuration

In a QMS Vault in which you want to automate much of the effectiveness check process, the following configurations help reduce the amount of manual work involved. Using all of these configurations together can create a cohesive automated effectiveness check process for your Quality Events, CAPA Action Items, or Complaints. Note that different Quality Event, CAPA Action Item, or Complaint object and lifecycle configurations may require different steps than those described below. You should evaluate and configure automation to fit your specific process needs.

Effectiveness Check Object Record Event Actions

Using the Update Record Field record event action, populate values on the newly created Effectiveness Check record according to your needs. For example, you can optionally set the precondition to check if the reference field chosen during configuration of the entry action is not blank, then set the following record field updates:

  • Set the Title field of the Effectiveness Check record to match or be created from the Title field (or other text field of your choice) of the related object.
  • Set the record’s Due Date field value based on values from the parent-process record, such as setting the Due Date based on the parent record’s Action Completed Date plus 120 days.
  • Set the record’s Effectiveness Check Start Date field value based on values from the parent-process record, such as setting the Due Date based on the parent record’s Action Completed Date plus 90 days. This field setting is intended to be used with Job automation to ensure that your Effectiveness Check workflow begins, in this example, 30 days before the due date.

Furthermore, you can use event actions to start a workflow and prompt a user (either the record owner, or a Quality Team member in the appropriate role) to populate fields upon creation of the record, and to change the Effectiveness Check record to a state designating that it is waiting for automation, such as a “Waiting for Start Date” state. This is useful for setting fields on the Effectiveness Check which cannot be set using an Update Record Field event action, such as a User field, Object Reference field, or a Long Text field. Having the record in a special waiting-for-automation state allows you to configure jobs to only auto-start workflows on Effectiveness Check records which have had all of their set-up completed.

Automating the Effectiveness Check Workflow Start

Using Vault’s jobs functionality, you can automate the start of the Effectiveness Check activity at the appropriate time. To create such a job:

  1. Update the Effectiveness Check lifecycle to include an “Effectiveness Check Auto-Start” state. This is the state that begins the review of the effectiveness check, and the workflow should transition the record immediately out of it into your configuration process states.
  2. Navigate to Admin > Operations > Job Definitions.
  3. Click Create.
  4. Configure a job that checks the age of the Effectiveness Check record and, if appropriate, changes the Effectiveness Check’s state to the “Effectiveness Check Auto-Start” state so that your effectiveness check workflow work can automatically start:
    • Type: Date Based Object Operation
    • Action: State Change
    • Object: Effectiveness Check
    • Change State To: Effectiveness Check Auto-Start
    • Additional Conditions: Enter appropriate constraints which indicate that an Effectiveness Check record has all requisite data to be started, such as Lifecycle State equals Waiting for Start Date, or Description is not blank
    • Trigger Date: Effectiveness Check Start Date, is on or before, job run date