Example of An Internal Audit SOP
Example of An Internal Audit SOP
Example of An Internal Audit SOP
PURPOSE
Define the responsibilities, actions and procedures used in managing and carrying out internal audits.
The company shall establish and conduct a process of internal auditing to verify that all quality and food
safety records and functions described in the Food Safety and Quality Policy Manual are conducted.
SCOPE
All internal audit activities of the food safety management system
FREQUENCY
Frequency of internal audit activities are described in the procedures
RESPONSIBILITY
Senior site manager: Provides authority for audits; sets expectations for operational personnel; approves
audit schedule; provides resources for training auditors; ensures audit findings are reviewed and corrective
actions are implemented; where necessary, ensures root cause analysis and preventive actions are
implemented to prevent reoccurrence of non-conformance.
Audit program manager: Develops and calibrates internal auditors; plans and schedules audits
Operational managers: Provide resources to participate in audit activities; address non-conformances;
investigate root cause and develop corrective actions as needed; support the continual improvement
process.
Internal auditors: Carry out thorough internal audits as scheduled against the prescribed standards;
accurately report audit findings; support the implementation and continual improvement of the food safety
system.
PROCEDURES
Audit Team
Audit team members shall be selected based on established auditor characteristics, suitability and their
knowledge and experience. The determination shall be made by the senior site manager and the audit
program manager. An objective of selection shall be the development and maintenance of a multidisciplinary
audit group.
Audit team members shall be trained in principles and practices for internal auditing by a qualified individual
with appropriate experience. Training may be conducted internally or by an external training service.
Audit team members shall participate in required site specific training and calibration activities and shall be
witnessed and calibrated by the audit program manager prior to auditing on their own.
Each auditor’s performance shall be reviewed annually by the audit program manager.
The number of auditors shall be appropriate so that auditors are independent of the function being audited.
If necessary outside auditors may be employed to maintain independence.
Audit assignments will be based on knowledge and experience and so that auditors are independent of the
function being audited.
The complete food safety management system shall be verified through internal audit at least annually
The frequency of internal audit activities shall be based on risk assessment, regulatory and customer
requirements and best audit practices. The frequency shall be re-assessed based on findings, problems and
deviations by the audit program manager. Increased frequency may be required to verify that control of the
system is being maintained.
Internal audits shall be differentiated from GMP inspections.
• Copy the completed checklist with non-conformances to the department head and audit manager.
• Enter the non-conformances into the CAPA tracking system.*
• Verify corrective and preventive action. Monitor the completion of corrective and preventive action for
areas audited. Schedule a verification activity once corrective action is complete to determine the
completeness and effectiveness of the actions
* Responsibility and targets for completion of corrective and preventive actions are determined by the
department manager and/or discussed, determined and agreed to during operational meetings.
Verification
The audit program manager shall prepare a quarterly report for the senior site manager to report on the
completion and effectiveness of the internal audit program and CAPA progress.
Records
• Audit reports
• CAPA tracking System
• Deviation and Corrective Action Records
• Quarterly Management Report