Standard Operating Procedure (SOP) for Supplier Audits and Performance Reviews

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Introduction:
Ensure the reliability, compliance, and quality of your supply chain with our Standard Operating Procedure (SOP) for Supplier Audits and Performance Reviews. Developed for organizations in regulated environments such as pharmaceuticals, biotechnology, and medical devices, this SOP provides a structured and compliant approach for evaluating, qualifying, and continuously monitoring suppliers to meet regulatory and operational requirements.

Overview:
The SOP for Supplier Audits and Performance Reviews outlines standardized procedures for initial supplier qualification, ongoing evaluations, audit planning, execution, documentation, and risk-based performance reviews. By following this SOP, companies can establish a robust supplier management program that aligns with FDA 21 CFR Part 820, Part 211, ICH Q10, and ISO 13485 standards.

Key Sections Included in the SOP:

1. Purpose:
   Defines the objective of ensuring that suppliers consistently provide goods and services that meet quality and regulatory requirements through structured audits and performance evaluations.
2. Scope:
   Applies to all external suppliers and service providers whose materials, components, or services directly or indirectly affect product quality, safety, or regulatory compliance.
3. Responsibilities:
   • Quality Assurance (QA): Oversees the supplier evaluation program and conducts audits.
   • Procurement/Supply Chain: Maintains approved supplier lists and ensures supplier communication.
   • Technical SMEs: Support evaluation and audit processes for technical compliance.
   • Supplier Relationship Owners: Monitor performance and resolve non-conformances.
4. Supplier Qualification and Approval:
   • Outlines criteria for initial qualification based on supplier type, risk classification, certifications, and prior performance.
   • Includes completion of supplier questionnaires, risk assessments, and sample evaluations.
5. Audit Planning and Scheduling:
   • Details how to develop a risk-based supplier audit schedule based on material criticality, past performance, and regulatory impact.
   • Includes provisions for on-site and remote audits.
6. Audit Execution:
   • Specifies pre-audit activities such as scope definition, agenda development, and auditor assignments.
   • Defines how audits are conducted, including document review, facility inspection, personnel interviews, and sampling.
7. Audit Reporting and Follow-Up:
   • Requires formal audit reports detailing observations, ratings (critical/major/minor), and required corrective actions.
   • Sets timelines for supplier response and CAPA implementation, including verification of effectiveness.
8. Supplier Performance Monitoring:
   • Establishes metrics for ongoing performance reviews such as on-time delivery, quality of goods, responsiveness, deviation frequency, and complaint history.
   • Provides for periodic performance scoring and risk reclassification.
9. Supplier Risk Assessment:
   • Describes methodology for scoring and ranking suppliers based on risk and compliance history.
   • Supports decisions on increased surveillance, requalification, or disqualification.
10. Non-Conformance and Escalation Process:

• Outlines the process for handling supplier-caused non-conformances, deviations, or failures.
• Includes escalation triggers for critical or repeated issues.

1. Supplier Communication and Development:

• Encourages collaborative communication to support quality improvements and clarify expectations.
• May include training or joint quality initiatives with key suppliers.

1. Documentation and Recordkeeping:

• Requires maintenance of audit reports, CAPA records, supplier communications, qualification documents, and performance metrics in a validated system.

1. Audit and Inspection Readiness:

• Ensures that supplier audit programs and records are available for review during regulatory inspections or customer audits.

1. Training and Competency:

• Specifies training requirements for auditors and supply chain personnel involved in evaluations and audits.
• Includes periodic requalification and documentation of audit skills.

Why Download This SOP?

• Ensure a Compliant Supply Chain: Stay aligned with global regulatory expectations for supplier management.
• Reduce Supply Risks: Identify, assess, and mitigate risks that could impact product quality or delivery.
• Strengthen Supplier Relationships: Promote transparency, accountability, and continuous improvement.
• Drive Operational Efficiency: Streamline supplier evaluations and reduce the likelihood of quality failures.
• Be Audit-Ready: Maintain thorough, up-to-date documentation of supplier oversight activities.

Support and Contact Information:
For questions or additional guidance on supplier audit or performance review procedures, please reach out to our support team. We’re here to help you build a dependable and compliant supplier network.