Comprehensive Guide to Supplier Qualification and Audits in Medical Device Manufacturing

1) Purpose

This SOP outlines the procedures for evaluating, qualifying, and auditing suppliers to ensure that raw materials, components, and services provided meet quality and regulatory requirements. Establishing a robust supplier qualification process ensures the reliability of the supply chain and minimizes risks to medical device manufacturing processes.

2) Scope

This SOP applies to the procurement and quality management teams responsible for supplier qualification and audits. It covers all suppliers providing materials, components, or services used in the production of medical devices. The procedure is applicable to new supplier evaluations, periodic requalification of existing suppliers, and audits triggered by performance concerns.

3) Responsibilities

– Procurement Team: Initiates supplier qualification processes, maintains supplier records, and communicates requirements to suppliers.
– Quality Assurance (QA): Conducts supplier evaluations, reviews audit reports, and approves or disapproves suppliers based on compliance.
– Supplier Quality Team: Performs on-site and remote audits, ensures follow-up on corrective actions, and monitors supplier performance.
– Regulatory Affairs Team: Verifies that suppliers comply with applicable regulatory requirements.
– Production Team: Provides feedback on supplier performance and material quality.

4) Procedure

4.1 Supplier Identification and Pre-Qualification
4.1.1 Supplier Identification:
– Identify potential suppliers based on material requirements, certifications, and references.
4.1.2 Pre-Qualification Checklist:
– Verify initial credentials such as ISO 13485 certification, FDA compliance, or other industry-specific certifications.
– Request and review supplier documentation, including quality policies, processes, and previous audit results.
4.1.3 Approval for Initial Qualification:
– Shortlist suppliers for further evaluation based on the pre-qualification checklist.

4.2 Supplier Qualification
4.2.1 Supplier Questionnaire:
– Send a detailed supplier questionnaire to gather information about quality systems, production capabilities, and regulatory compliance.
4.2.2 Risk Assessment:
– Perform a risk assessment of the supplier based on criticality of materials, historical performance, and geographical factors.
4.2.3 Initial Site Audit:
– Schedule and conduct an on-site audit, if required, to verify compliance with standards such as ISO 13485 and GMP (Good Manufacturing Practices).
4.2.4 Evaluation of Test Samples:
– Request and evaluate test samples to ensure they meet quality specifications.
4.2.5 Supplier Approval:
– Approve the supplier and add them to the Approved Supplier List (ASL) after successful qualification.

4.3 Supplier Audits
4.3.1 Types of Audits:
– Initial Audit: Conducted during the supplier qualification process.
– Periodic Audit: Regularly scheduled audits to ensure ongoing compliance.
– Triggered Audit: Conducted in response to performance issues, complaints, or regulatory changes.
4.3.2 Audit Planning:
– Develop an audit plan specifying the audit scope, criteria, and schedule.
4.3.3 Audit Execution:
– Use an audit checklist to evaluate supplier processes, quality management systems, and regulatory compliance.
– Record findings, including non-conformances, observations, and areas of improvement.
4.3.4 Audit Reporting:
– Generate a comprehensive audit report summarizing findings, corrective actions, and deadlines.
4.3.5 Follow-Up Actions:
– Monitor supplier progress on corrective actions and conduct follow-up audits if necessary.

4.4 Supplier Performance Monitoring
4.4.1 Key Performance Indicators (KPIs):
– Track KPIs such as on-time delivery, defect rate, and responsiveness to issues.
4.4.2 Performance Reviews:
– Conduct periodic performance reviews to assess supplier reliability and quality.
4.4.3 Supplier Scorecards:
– Use scorecards to rate suppliers and identify areas for improvement.

4.5 Disqualification of Suppliers
4.5.1 Criteria for Disqualification:
– Failure to meet quality standards, repeated non-conformances, or unresolved corrective actions.
4.5.2 Supplier Notification:
– Inform the supplier of disqualification, citing specific reasons and evidence.
4.5.3 Record Maintenance:
– Update the supplier database and Approved Supplier List (ASL) to reflect disqualification status.

5) Abbreviations

– ASL: Approved Supplier List
– GMP: Good Manufacturing Practices
– KPI: Key Performance Indicator
– QA: Quality Assurance

6) Documents

– Supplier Pre-Qualification Checklist
– Supplier Questionnaire
– Audit Plans and Checklists
– Audit Reports
– Supplier Performance Scorecards

7) Reference

– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 9001: Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Supplier Pre-Qualification Checklist

Annexure 2: Supplier Audit Report Template