Supplier Audit Standard Operating Procedure

I. Purpose

The Supplier Audit Standard Operating Procedure (SOP) outlines the procedure for assessing and evaluating suppliers' performance, quality, and compliance with contractual requirements and regulatory standards to ensure that they meet [Your Company Name]'s expectations and contribute to product quality and safety.

II. Scope

This SOP applies to all suppliers engaged in providing goods or services to [Your Company Name].

III. Responsibility

A. [Your Department]

Identify suppliers requiring an audit.
Schedule supplier audits.
Conduct supplier audits according to this SOP.
Document audit findings and follow-up actions.

B. Supplier Quality Assurance Representative

Cooperate with [Your Department] in scheduling audits.
Provide necessary documentation and access during audits.
Address corrective actions resulting from audits.

IV. Procedure

A. Audit Preparation

Audit Planning

Define audit objectives.
Determine audit criteria and scope.
Select audit team members.

Pre-Audit Documentation Review

Review supplier documentation, including contracts, quality manuals, and previous audit reports.

B. Audit Execution

On-Site Audit

Conduct opening meetings with supplier representatives.
Review supplier processes, facilities, and quality management systems.
Collect objective evidence through interviews, observations, and document reviews.
Document non-conformities and opportunities for improvement.

Closing Meeting

Present audit findings to supplier representatives.
Discuss non-conformities and opportunities for improvement.
Agree on corrective actions and timelines.

C. Audit Reporting

Audit Report

Compile audit findings, including non-conformities and opportunities for improvement.
Include evidence collected during the audit.
Distribute the audit report to relevant stakeholders.

Corrective Action

Collaborate with suppliers to develop corrective action plans for identified non-conformities.
Monitor implementation of corrective actions.

D. Follow-Up Audit

Verification

Conduct a follow-up audit to verify the implementation of corrective actions.
Validate the effectiveness of corrective actions.

V. Documentation

A. Maintain records of all supplier audits, including audit reports, corrective action plans, and verification of corrective actions.

B. Ensure confidentiality and security of audit records following [Your Company Name] policies and applicable regulations.

VI. Training and Competency

A. Train personnel involved in supplier audits on relevant procedures, audit techniques, and regulatory requirements.

B. Evaluate and maintain the competency of audit team members through regular training and performance assessments.

VII. Revision History

Review Frequency: The SOP should be reviewed annually or following any major changes within the department.
Revision History: A log of changes made to the SOP for tracking and reference purposes.