QMS Audits allows you to create and manage Audit Programs, which are a schedule of audits to happen over a period of time, such as a quarter or a year. Audits can be internal or external, outsourced or not. You can create and manage Audit within an Audit Program or independently.
Audit Program
- Schedule of audits over a period of time
Proposed Audit
- Can be either external or internal
- Used to generate audits on specified dates
External Audit
- Your organization is auditing a supplier
Internal Audit
- Your organization is auditing itself, for example, a mock inspection or audit of a particular department
Outsourced Audit
- Can be either external or internal
- Owning organization is a supplier acting on behalf of your organization
Audit Process
- Creating Audit Programs & Audits: Create an Audit Program and associated Proposed Audits. Or, create an Audit outside of a program.
- Initiating & Preparing an Audit: Initiate and prepare an audit.
- Creating Findings: After the audit is conducted, record Audit Findings.
- Completing an Audit Report: Complete the Audit Report and send it for approval.
- Issuing Audit Report: After the audit report is approved, issue the report to the supplier. This step applies to external audits only.
- Responding to Findings: Finding Owner responds to Audit Findings, including issuing CAPAs and Effectiveness Checks for internal Audits.
- Completing Audits & Audit Programs: Complete Audits and Audit Programs.
About QMS Audit Teams
When you create an Audit Program or Audit, you are prompted to select the team members responsible. Records created from an Audit Finding, such as CAPA Actions and Effectiveness Checks, also require you to select the responsible team members.
When you first create a record that requires a team, a team required icon () is displayed in the left panel and the Team section heading. After adding and saving the team members, the icon is removed and the record can progress to its next lifecycle stage.
The following team roles are available, but not all roles are required for all records:
- Owner: The Owner assigned to a record is responsible for managing and performing the main actions or tasks associated with the record. For example, the Owner of an Audit is responsible for, for example, preparing the audit report and creating findings.
- QA Approver: The QA Approver assigned to a record is responsible for performing the final quality review and approval. The QA Approver is typically a member of the Quality team. For example, the QA Approver is responsible for confirming that the outcome details in an Effectiveness Check were performed according to the Results information documented in the Effectiveness Check record.
When defining a team, you can select multiple QA Approvers. If you select multiple users for these roles, all selected users must select the Approve verdict for the record to be considered approved. If at least one approver selects the Reject verdict, the record is rejected and returned to the Owner.