Standard Operating Procedure for Internal Audits

1) Purpose

The purpose of this SOP is to establish procedures for conducting internal audits to assess the effectiveness of the quality management system, identify areas for improvement, and ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all departments and functions within the manufacturing facility that are subject to internal audit as part of the quality management system.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Internal Audit Manager:

Responsible for planning, conducting, and reporting internal audit findings.

3.2 Auditors:

Trained personnel responsible for conducting audits according to established procedures.

3.3 Department Heads:

Responsible for addressing audit findings and implementing corrective actions as needed.

4) Procedure

4.1 Audit Planning:

4.1.1 Define audit scope, objectives, and criteria based on regulatory requirements and business needs.
4.1.2 Develop an audit plan including audit schedule, checklist, and resources.
4.1.3 Obtain approval of the audit plan from management and relevant stakeholders.

4.2 Audit Execution:

4.2.1 Conduct opening meeting to communicate audit objectives, scope, and process.
4.2.2 Perform audit activities including document review, interviews, and observations.
4.2.3 Collect and analyze audit evidence against audit criteria and requirements.

4.3 Audit Reporting:

4.3.1 Prepare audit findings and observations in the Audit Report.
4.3.2 Classify findings based on severity and impact on compliance and quality.
4.3.3 Obtain management responses to audit findings and agree on corrective actions.

4.4 Corrective Action and Follow-Up:

4.4.1 Develop corrective action plans (CAPA) for identified non-conformities.
4.4.2 Assign responsibilities and timelines for implementing CAPA.
4.4.3 Verify effectiveness of corrective actions through follow-up audits or reviews.

4.5 Audit Closure and Documentation:

4.5.1 Conduct closing meeting to summarize audit findings, conclusions, and actions.
4.5.2 Archive audit records including Audit Report, CAPA, and management responses.
4.5.3 Review and improve audit procedures based on audit findings and feedback.

5) Abbreviations, if any

CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Audit Plan
2. Audit Checklist
3. Audit Report
4. Corrective Action Plans (CAPA)
5. Audit Records

7) Reference, if any

1. ISO 19011:2018 Guidelines for auditing management systems
2. FDA Quality System Inspection Technique (QSIT) Guide

8) SOP Version

Version 1.0