The purpose of this procedure is to define the methods used to audit the Quality System that is in operation.
Internal Quality Audits are systematic reviews of systems and procedures. Internal audits must be undertaken against each procedure at least annually. Should the system not be functioning correctly audits should take place more frequently.
It is the responsibility of the Quality Assurance Manager to ensure that this procedure is carried out and control the frequency and implementation of Quality Audits.
The Quality Assurance Manager will have the responsibility for initiating and recording audits. An audit of each of the activities will be carried out at least once per year but more frequently should any activity require it. Each audit will be conducted by the either the Quality Assurance Manager or internal trained Auditors. The audit will be a planned activity and controlled by an audit schedule prepared in advance by the Quality Assurance Manager.
CARRYING OUT AN AUDIT
Audits will be carried out by personnel independent of those having direct responsibility for the activity being audited. Controls will be maintained to ensure that the Internal Audit function itself is regularly audited. All audits will be carried out as defined in the Guide to Quality Systems Auditing.
Each audit will consist of:
- Opening Meeting
- Performing the audit
- Audit reports
- Corrective actions and observations
- Closing meeting
All audits will be logged and Corrective Action Requests will be recorded on the corrective action request status log.
Checklists will be prepared on an internal audit checklist form. Checklists and any other relevant information will be retained as part of the record of the audit. Audit Reports will be issued recording the results of the audit including any necessary action to be taken. Any Corrective Action Requests will be issued using the Corrective Action Request form.
The Quality Assurance Manager will be responsible for ensuring that audit reports are passed to the appropriate person for that department. Procedures will be updated or revised when changes are recommended as the result of audits. Records of the audit will be kept in the quality file held by the Quality Assurance Manager and will be retained for at least three years.