In Veeva Quality Basics: QMS you can create and manage audit programs, which are a schedule of audits to happen over a period of time, such as a year or a quarter. When you create an audit program, you define the proposed external and internal audits that are planned during that time period. A benefit of using audit programs is that audits will be automatically generated for you on the specified dates.

Creating an Audit Program

To create an audit program:

  1. Navigate to QMS > Audits & Supplier Management > Audit Programs and click Create.
  2. Provide a Name for the audit program, as well as the Planned Start and End Date.
  3. Click Save.

Creating a Proposed Audit

Once the audit program has been created, you can start adding proposed audits.
To add a proposed audit to an audit program:

  1. Navigate to the audit program record.
  2. Open the Proposed Audits section and click Create.
  3. Select the Proposed Audit Type: Internal or External. Your audit program can contain a mix of types.
  4. Click Continue.
  5. Fill out the required proposed audit information. Note that -
    • For external audits, Auditee is the supplier being audited
    • Owning Organization can be either your organization or another supplier, if the audit will be outsourced and conducted by a third party
    • For internal audits, there is an extra field - Audited Department. Provide either the Auditee or the Audited Department.
    • When part of an audit program, audits will be created automatically 14 days prior to the Planned Start Date to allow time to prepare materials and get ready for the audit.
  6. Click Save.
  7. Click Manage Team.
  8. Specify the Audit Owner.
    The audit owner is responsible for entering the audit details into the system. For in-house audits, this will most likely be the lead auditor. For outsourced audits, the audit owner is the person who will be entering the provided audit report information.
  9. Optionally, specify the Audit QA Approver(s). QA Approver is optional at the proposed audit level. The audit owner will be required to provide the QA Approver(s) on the audit itself.
  10. Click Save.
  11. Repeat to add additional proposed audits to the program.

Unplanned Audits

During the timeline of your audit program, an unplanned audit may occur. You have the choice to create and manage it outside of the program or within it. If you want to add an unplanned audit to a program, you can add it in the Unplanned Audits section.

Sending an Audit Program for Approval

Once you have planned out your audit program,added the proposed audits for the specified time range, and added the team to each proposed audit, the audit program will need to be approved.

To send an audit program for approval:

  1. Navigate to the audit program record and click Manage Team.
  2. Add one or more QA Approvers.
  3. Click Save.
  4. Select Send for Approval from the Workflow menu.
  5. Click Start.
    The QA Approvers will receive a task to approve the audit program.

Creating an Audit Outside of a Program

To create an audit outside of a program:

  1. Navigate to QMS > Audits & Supplier Management > External Audits or Internal Audits and click Create.
  2. Provide the required information for the audit and click Save.
  3. Click Manage Team.
  4. Specify the Audit Owner and QA Approver(s). Optionally, you can select one or more Co-Auditors. These are other users who may contribute to the audit report.
  5. Click Save.
  6. Start the audit workflow. If the audit is being conducted in-house, select Send for Preparation from the Workflow menu.
    The Audit Owner will receive a task to complete the audit preparation.