The purpose of quality system audits is to verify whether or not the processes have been implemented properly and the specified requirements are met.
In this blog post, I am explaining the roles and responsibilities of each participant during a Quality Management System (QMS) audit.
Audit Client's Roles
An audit client is an organization or person requesting an audit. Typical roles of an audit client include:
- Initiates audit
- Determines audit purpose and scope
- Provide resources
- Receives the audit report
- Determine the report distribution
Auditors are responsible for verifying the implementation and effectiveness of the processes and procedures used by employees and contractors to meet the requirements of the QMS.
An Auditor will be required to perform the following tasks:
- Understand the purpose, scope and audit criteria
- Plans the audit
- Perform the audit
- Collect audit evidences
- Analyze audit evidences
- Follows up the action on audit findings
Lead Auditor's Roles
The lead auditor should provide direction and support to the rest of the team throughout the audit. They should keep the team focused on the objectives of the audit. They should communicate clearly and concisely with the audit team, client and auditee.
An auditee is an organization as a whole or parts thereof being audited.
A typical role of an auditee includes the following:
- Inform the staff in the organization about the audit so that they are available for the audit.
- Provide resources to the audit team (interview room, communications and clerical support)
- Provide guides to the audit team (if needed)
- Show objective evidence when an auditor requests these
- Cooperate with the audit team
- Determine and initiate corrective actions (in case a non-conformity is identified)
In addition to these three prominent roles in an audit, the audit process might also involve these additional support roles:
Technical Expert: a person who provides specific knowledge or expertise to the audit team
Observer: a person who accompanies the audit team but does not act as an auditor.
Guide: a person appointed by the auditee to assist the audit team.