Vault QMS supports management of the Quality Management Review (QMR) process, which is an evaluation of the effectiveness and suitability of a quality system. It is a collaborative effort to determine whether the system needs adjustments to meet quality requirements. The QMR object captures meeting notes, meeting attendees, and post-meeting action items.
While the QMR process, as well as object and action labels, may differ between organizations, the examples in this article assume a typical configuration. The procedure in your Vault may differ, depending on the configuration determined by your Admin.
How QMR Management Works
QMR management in Vault QMS centers around the QMR object, one or more Management Review Templates, and actions available on the associated object records. When you create a QMR object record from a template, Vault transfers data to that record based on the configuration of the chosen template.
The QMR process typically includes meetings in which minutes are captured, tasks assigned, and documents produced, which Vault stores in data fields, QMR Task records, and QMR Item records respectively. When you create a QMR record from a Management Review Template, Vault also creates any QMR Items which were included on the template.
You can use actions available on QMR Item records to create related documents, and add meeting minutes in text fields on the QMR record.
Example QMR Process Overview
When performed in Vault QMS, a typical QMR process includes some or all of the following components:
- Create a Management Review Template
- Create a QMR object record
- Conduct meetings and record meeting notes and minutes in the QMR record
- Add or generate documents for QMR Items
- Finalize the QMR record
Creating Management Review Templates for QMRs
To create a Management Review Template for use in a typical QMR process:
- Navigate to Admin > Business Admin > Management Review Templates or to a custom object tab.
- Click Create.
- Fill in a Name and any other fields which all QMRs in your process will require. When you create a QMR record from this template, Vault transfers field data such as Country, Owning Facility, and QMR Scope to the resulting record, along with any other fields configured by your Admin to transfer data.
- Click Save.
- In the Management Review Template Item section, click Create to make a related Management Review Template Item object for each expected item in your QMR process.
- If applicable, select a Document.
- Click Save.
While you can create a QMR record manually, use the following steps to create a QMR from a template:
- Navigate to a Management Review Template record of the QMR object type, either in Admin > Business Admin or in a custom object tab.
- Perform the Create Record From Template action on the record. When you perform this action, Vault creates the QMR record, gives it a system-managed record name, and transfers data and QMR Item related records from the template to the new record.
- On the resulting QMR record, add any additional information, such as meeting minutes or agenda, to the appropriate text fields.
Creating QMR Tasks
During the course of the QMR process, you may need to track tasks which participants should complete before or after the review:
- In the QMR Tasks section of the QMR record, click Create.
- In the drop-down, select either Pre-Meeting Action Item or Post-Meeting Action Item.
- Fill in any additional details, such as a task assignee or due date.
- If you are tracking a previously-completed task, select a value of Yes for the Complete field and add a Completed On date and time. You can also perform the Complete action on the QMR Task record, which automatically populates the date and time.
Generating QMR Item Documents
QMR processes typically include gathering existing Vault documents, such as presentations, and documents generated in the course of the review. Some documents may be automatically generated when you create the QMR record from the template. Others, such as documents created from reports, formatted outputs, or document templates, can be created by performing the appropriate action on the QMR Item record:
- Navigate to the QMR Item section of the QMR object record details page.
- Perform the document generation action on the QMR Item record. For example, perform the Generate Document from Report action to attach a PDF version of the report to the QMR Item record.
When you perform this action, Vault populates a document reference field on the QMR Item record with a link to the generated document. The availability and labels of document generation actions depend on the configuration of your Vault, as determined by an Admin.
Adding QMR Presentation
During the QMR process, participants typically produce a presentation relevant to the review. You can attach this item to the QMR record in the QMR Presentation field:
- Add the presentation to Vault as a document.
- From the QMR record details page, perform the Edit action.
- Select the presentation document in the QMR Presentation field.
- Click Save.
Finalizing a QMR
Review and finalize the QMR record per your organization’s processes.
Your security profile requires the following permissions to work with QMRs:
|Document Types created by Quality Document Generation Actions||Create Document||Ability to create documents for QMR Items|
|Security Profile||Object: Management Review Template: Create, Read, Edit, Delete||Ability to create, view, edit, and delete Management Review Templates for use as the basis of QMR record creation|
|Security Profile||Object: Management Review Template Item: Create, Read, Edit, Delete||Ability to create, view, edit, and delete Management Review Template Items for use as the basis of QMR Item record creation|
|Security Profile||Object: QMR: Create, Read, Edit, Delete||Ability to view, create, edit, and delete QMR records during the QMR process|
|Security Profile||Object: QMR Item: Create, Read, Edit, Delete||Ability to create, view, edit, and delete QMR Item records during the QMR process|
|Security Profile||Object: QMR Task: Create, Read, Edit, Delete||Ability to create, view, edit, and delete QMR Task records during the QMR process|