Standard Operating Procedure for Vendor Audit

Standard Operating Procedure (SOP) for Vendor Audit

1. Purpose

  • To ensure that vendors comply with regulatory requirements, quality standards, and contractual obligations.

2. Scope

  • This procedure applies to all vendors providing goods or services to the organization.

3. Responsibilities

  • Management:
    • Appoint an audit team.
    • Review audit findings and take appropriate actions.
  • Audit Team:
    • Conduct audits according to this procedure.
    • Document audit findings and recommendations.

4. Pre-Audit Preparation

  • Selection of Vendors:
    • Identify vendors to be audited based on risk assessment, performance history, and criticality to operations.
  • Audit Planning:
    • Define audit objectives, scope, and criteria.
    • Schedule audit with the vendor and internal stakeholders.
  • Documentation Review:
    • Review vendor contracts, quality agreements, and previous audit reports.

5. On-Site Audit Procedures

  • Opening Meeting:
    • Introduce audit team and explain objectives.
    • Review audit agenda and expectations.
  • Documentation Review:
    • Verify vendor documentation such as quality management system procedures, certifications, and records.
  • Facility Inspection:
    • Evaluate vendor facilities, equipment, and infrastructure for compliance with regulatory and quality standards.
  • Interviews:
    • Conduct interviews with key personnel to assess knowledge, training, and adherence to procedures.
  • Sampling and Testing:
    • Collect samples of products or materials for testing if applicable.

6. Audit Reporting

  • Findings Documentation:
    • Document audit findings, including observations, deviations, and non-conformities.
  • Root Cause Analysis:
    • Identify root causes of non-conformities and deficiencies.
  • Risk Assessment:
    • Assess the risk associated with identified issues.
  • Report Preparation:
    • Prepare a comprehensive audit report detailing findings, conclusions, and recommendations.

7. Post-Audit Activities

  • Corrective Actions:
    • Issue corrective action requests to the vendor for addressing non-conformities.
  • Follow-Up:
    • Monitor vendor responses and corrective actions.
    • Conduct follow-up audits as necessary to verify effectiveness of corrective actions.

8. Audit Closure

  • Final Review:
    • Review audit findings, corrective actions, and closure status.
  • Approval:
    • Obtain approval from management for audit closure.
  • Documentation:
    • Archive audit documentation for future reference.

9. Records Management

  • Retention:
    • Maintain audit reports, correspondence, and records in accordance with regulatory requirements and organizational policies.
  • Accessibility:
    • Ensure that audit records are readily accessible for regulatory inspections and internal audits.

10. Training and Continuous Improvement

  • Training:
    • Provide training to audit team members on audit techniques, regulations, and quality standards.
  • Lessons Learned:
    • Conduct periodic reviews of audit findings to identify trends and opportunities for improvement.

11. References

  • List applicable regulatory requirements, industry standards, and organizational policies guiding vendor audits.

12. Definitions

  • Define key terms used in this procedure for clarity and consistency.

13. Revision History

  • Document changes made to the procedure over time, including revision dates and reasons for updates.

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