FDA QMSR Traceability Policy, SOP & Forms

FDA QMSR Traceability Policy, SOP & Forms

FDA QMSR Traceability Policy, SOP & Forms

Identification and Traceability templates for FDA QMSR compliance.

✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
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🌐 ISO 13485:2016 §7.4.1 / §8.5.2
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📝 MS Word (.docx)
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🔄 Immediate Use
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🎬 Video Guidance on YouTube

Overview

A complete Supplier Corrective Action Request (SCAR) template set for FDA QMSR compliance. Provides structured procedures for issuing, tracking, and closing SCARs to drive supplier quality improvement and maintain supply chain compliance.

Regulatory Reference: ISO 13485:2016 §7.4.1 / §8.5.2 — Supplier Corrective Action

Why You Need This

ISO 13485:2016 §7.4.1 requires monitoring and re-evaluation of suppliers. A systematic SCAR process is essential for managing supplier non-conformances and maintaining a compliant supply chain under FDA QMSR.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure SCAR SOP English
📝 Form / Template MD-QMS-F5001 Supplier Investigation Request Form
📝 Form / Template MD-QMS-F5002 SCAR Form
📝 Form / Template MD-QMS-F5002 SCAR Form
📝 Form / Template MD-QMS-S5001 SCAR手順書

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. SCAR Information Sources
6. SCAR Issuance Criteria
7. SCAR Level Determination (Severity Assessment)
8. SCAR Issuance
8.1 Supplier Investigation Request
8.2 SCAR Issuance to Supplier
8.3 SCAR Follow-up
9. SCAR Data Analysis and Reporting
10. References
11. Supplementary Provisions

📋 SCAR SOP English — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Supplier Investigation Request
5.1 Investigation Request Form Issuance
5.2 Sending Investigation Request to Supplier
5.3 Receiving Investigation Request Response from Supplier
5.4 Investigation Form Response Review
6. SCAR Issuance
6.1 SCAR Initiation
6.2 Sending SCAR to Supplier
6.3 SCAR Follow-up
6.4 Receiving SCAR Response from Supplier
6.5 SCAR Content Review and Closure Approval
7. SCAR File and SCAR List Management
8. SCAR Data Analysis and Reporting
9. Forms
10. References
11. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.4.1 / §8.5.2 (Supplier Corrective Action)
  • Written for immediate use — minimal customization required
  • Structured for FDA QMSR (21 CFR Part 820) compliance
  • Microsoft Word format (.docx) — easy to edit and adapt
  • Professional quality suitable for FDA inspection review
  • Includes all required procedural elements and record templates
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