Standard Operating Procedure for Supplier Qualification and Management

1) Purpose

The purpose of this SOP is to establish procedures for the qualification, selection, evaluation, and management of suppliers to ensure a consistent supply of materials and services that meet quality and regulatory requirements.

2) Scope

This SOP applies to all departments and functions within the organization responsible for supplier management, including procurement, quality assurance, and production.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Procurement Manager:

Responsible for establishing and maintaining the supplier qualification program.

3.2 Quality Assurance (QA) Specialist:

Responsible for approving supplier qualification and monitoring supplier performance.

3.3 Production Manager:

Responsible for ensuring that only qualified suppliers are used for materials and services.

4) Procedure

4.1 Supplier Qualification:

4.1.1 Identify potential suppliers based on business needs and requirements.
4.1.2 Evaluate supplier capabilities, quality systems, and regulatory compliance.
4.1.3 Conduct supplier audits or assessments as necessary to verify capabilities.

4.2 Supplier Selection and Approval:

4.2.1 Select suppliers based on evaluation criteria including quality, reliability, and cost.
4.2.2 Obtain necessary documentation (e.g., certificates, quality agreements) from selected suppliers.
4.2.3 Approve suppliers for use based on evaluation results and regulatory requirements.

4.3 Supplier Performance Monitoring:

4.3.1 Monitor supplier performance through metrics such as on-time delivery and quality of materials.
4.3.2 Conduct periodic reviews or audits of supplier performance and compliance.
4.3.3 Address non-conformities or issues with suppliers through corrective actions.

4.4 Supplier Relationship Management:

4.4.1 Maintain regular communication with suppliers to ensure alignment on quality expectations.
4.4.2 Manage supplier relationships to foster collaboration and continuous improvement.
4.4.3 Update supplier records and qualifications as necessary based on performance reviews.

4.5 Supplier Change Control:

4.5.1 Evaluate and approve changes to supplier arrangements or specifications.
4.5.2 Document changes and communicate them to relevant departments.
4.5.3 Update supplier qualification records and documentation accordingly.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Supplier Qualification Checklist
2. Supplier Evaluation Reports
3. Supplier Audit Reports
4. Supplier Performance Metrics

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Supplier Evaluation and Control

8) SOP Version

Version 1.0