Comprehensive Guide to Conducting Internal Quality Audits
1) Purpose
The purpose of this SOP is to establish a systematic approach to planning, conducting, and documenting internal quality audits. These audits ensure that processes comply with established quality management system standards, regulatory requirements, and organizational policies, and that opportunities for improvement are identified.
2) Scope
This SOP applies to all internal quality audits conducted within the organization, including audits of production, quality control, quality assurance, regulatory compliance, and supporting departments. It is relevant to auditors, department managers, and quality assurance personnel.
3) Responsibilities
– Lead Auditor: Plans and leads the audit, ensures compliance with this SOP, and reports findings.
– Auditors: Conduct audits objectively, document findings, and identify areas for improvement.
– Department Heads: Provide access to processes and documentation, and ensure cooperation with auditors.
– Quality Assurance (QA): Oversees the audit process, reviews audit findings, and ensures implementation of corrective actions.
– Senior Management: Approves the audit schedule and reviews the audit summary report.
4) Procedure
4.1 Audit Planning
4.1.1 Annual Audit Schedule
– Develop an annual audit schedule specifying the areas to be audited, audit frequency, and assigned auditors.
– Obtain approval for the schedule from senior management.
4.1.2 Pre-Audit Preparation
– Review
– Define the audit scope, objectives, and criteria in the Audit Plan.
4.1.3 Audit Notification
– Notify the department or process owners of the audit at least one week in advance.
– Include the audit scope, objectives, and schedule in the notification.
4.2 Conducting the Audit
4.2.1 Opening Meeting
– Begin the audit with an opening meeting involving the audit team and department representatives.
– Explain the audit objectives, scope, and methods, and address any initial questions.
4.2.2 Process Review
– Observe processes in action to verify compliance with documented procedures and regulatory requirements.
– Note any deviations or non-conformities.
4.2.3 Documentation Review
– Review records and documents, such as standard operating procedures (SOPs), training records, and equipment logs.
– Verify that records are accurate, complete, and meet regulatory standards.
4.2.4 Personnel Interviews
– Interview employees involved in the processes to assess their understanding of procedures and compliance.
– Document responses to identify potential gaps or training needs.
4.2.5 Objective Evidence
– Collect objective evidence, such as photographs, data, and observations, to support audit findings.
– Ensure that evidence is factual, relevant, and clearly documented.
4.3 Classification and Documentation of Findings
4.3.1 Classification of Findings
– Classify findings based on their impact on quality and compliance:
– Major Non-Conformance: A significant deviation that may impact product quality or regulatory compliance.
– Minor Non-Conformance: A deviation with minimal impact but requiring correction.
– Observations: Opportunities for improvement without immediate compliance concerns.
4.3.2 Audit Report
– Document findings in the Audit Report, including:
– Non-conformance details
– Reference to applicable standards or procedures
– Evidence collected
– Recommendations for corrective or preventive actions
4.3.3 Exit Meeting
– Conduct an exit meeting with department representatives to present the audit findings.
– Discuss the non-conformances and agree on a timeline for corrective actions.
4.4 Post-Audit Activities
4.4.1 Corrective Action Plan (CAP)
– Collaborate with the audited department to develop a CAP addressing the identified non-conformances.
– Specify corrective actions, responsible personnel, and target completion dates in the CAP.
4.4.2 QA Review and Approval
– QA reviews and approves the CAP to ensure it effectively addresses the root causes of non-conformances.
4.4.3 Monitoring and Follow-Up
– Monitor the implementation of corrective actions through periodic follow-ups.
– Verify the effectiveness of actions taken and document the results in the Audit Follow-Up Report.
4.5 Audit Summary Report
4.5.1 Compilation
– Compile all individual audit reports, CAPs, and follow-up reports into a comprehensive Audit Summary Report.
– Highlight recurring issues, trends, and recommendations for process improvements.
4.5.2 Management Review
– Present the Audit Summary Report to senior management during the management review meeting.
– Use the report to guide strategic decisions and resource allocation.
5) Abbreviations
– QA: Quality Assurance
– CAP: Corrective Action Plan
– SOP: Standard Operating Procedure
6) Documents
– Audit Plan
– Audit Report Template
– Corrective Action Plan (CAP)
– Audit Follow-Up Report
– Audit Summary Report
7) Reference
– ISO 19011: Guidelines for Auditing Management Systems
– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: Audit Report Template
| Audit Date | Department | Findings | Classification | Recommendations | Auditor |
|---|---|---|---|---|---|
| DD/MM/YYYY | Department Name | Description of Findings | Major/Minor/Observation | Corrective Actions | Auditor Name |
Annexure 2: Corrective Action Plan Template
| Finding ID | Description | Corrective Action | Responsible Person | Target Completion Date | Status |
|---|---|---|---|---|---|
| Finding-001 | Description of Finding | Corrective Action Description | Responsible Name | DD/MM/YYYY | In Progress/Completed |