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
Pre-Audit Documentation Review
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
D. Follow-Up Audit
Verification
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
Revision Number | Date | Description of Changes | Revised By |
|---|
1 | [DATE] | Initial Creation of SOP | [YOUR NAME] |
2 | [DATE] | Updates to reflect changes in [PROCESS/REGULATIONS]. | [YOUR NAME] |
VIII. Approval
[APPROVER’S NAME]
[APPROVER’S ROLE]
[APPROVAL DATE]
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