Example of An Internal Audit SOP

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 3

Document IASOP 1001 v1 Internal Audit Procedures Page 1 of 3

Company Name: Issued by: Date (dd/mm/yr) :


Approved By: Supersedes (dd/mm/yr):
Initialed:

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 Planning, Scheduling, Frequency and Assignment


A schedule for the audit activities to be carried out over the course of the year shall be prepared by the audit
program manager and approved by the senior site manager.

This form is intended for instructional purposes only!


Document IASOP 1001 v1 Internal Audit Procedures Page 2 of 3
Company Name: Issued by: Date (dd/mm/yr) :
Approved By: Supersedes (dd/mm/yr):
Initialed:

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.

Audit Standards, Criteria and Checklist.


The audit program manager shall ensure that a current checklist appropriate to the standards of the food
safety management system shall be maintained and used by internal auditors.
The assessment criteria shall be established, communicated and understood by auditors and all
stakeholders of the food safety management system audits.

General Audit Process


• Contact the department(s) where audit(s) are to be conducted one to two weeks ahead and determine a
date and time frame for the audit.
• Communicate which activities will be undertaken (record review, observation, systems challenge,
interview etc), which people will be required and for how long they will be needed.
• Prior to visiting the department conduct document review.
o Review previous audit non-conformances and planned and verified corrective and preventive
actions
o Read and review all policies, procedures, work instructions, forms and other documents relevant
to the audit.
o Review for accuracy, relevance and for clarity and note any changes or opportunities for
improvement.
o Review records if appropriate to do so.
• Audit in the department.
o Meet with department head and audit participants and briefly
o Review the purpose and scope of audit
o Review the previous non conformance
o Communicate any issues found in the document review and determine if any issues found are
agreed by the department.
o Conduct the audit activities and gather the objective evidence.
o Communicate findings and assessment to participants as they are found. If not present during
the audit, meet with the department head at the end of the audit to review the audit and the
findings
• Post Audit activities
• Document the objective evidence and any non-conformances found during the audit and record on the
checklist.

This form is intended for instructional purposes only!


Document IASOP 1001 v1 Internal Audit Procedures Page 3 of 3
Company Name: Issued by: Date (dd/mm/yr) :
Approved By: Supersedes (dd/mm/yr):
Initialed:

• 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.

Deviation And Corrective Action


Missed scheduled audits or missed deadlines for corrective action shall be reported during operations
meeting and corrective action established to establish conformance. This may require:
• Additional resources.
• Review of capability and capacity
• Changes to schedules and targets

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

This form is intended for instructional purposes only!

You might also like