Supplier Management SOP

This procedure defines the process for evaluating, approving, monitoring, and re-evaluating suppliers of materials, components, and services that affect the quality of medical devices. It ensures that purchased products and services conform to specified requirements and that supplier risk is managed appropriately.

This procedure applies to all suppliers providing: - Raw materials and components used in medical device manufacturing - Finished or semi-finished subassemblies - Sterilization, testing, calibration, or other outsourced processes - Contract manufacturing services - Critical packaging and labeling materials - Software or electronic components incorporated into devices Suppliers of non-quality-affecting goods (office supplies, general maintenance) are excluded unless they provide services that could impact product quality.

Purchasing / Supply Chain: Identify potential suppliers, coordinate qualification activities, maintain the Approved Supplier List (ASL), and manage purchase orders. Quality Assurance: Evaluate supplier quality systems, conduct supplier audits, perform incoming inspection, issue Supplier Corrective Action Requests (SCARs), and approve/reject suppliers. Engineering: Define technical specifications and acceptance criteria for purchased materials and components. Quality Manager: Approve the ASL, review supplier performance metrics, and make final decisions on supplier qualification and disqualification.

4.1 Supplier Evaluation & Qualification - New suppliers are evaluated using the Supplier Evaluation Form (FRM-SM-001) considering: - Quality system certification (ISO 13485, ISO 9001, etc.) - Regulatory compliance history (FDA establishment registration, warning letters, recalls) - Technical capability and capacity - Financial stability - Supply chain risk (single source, geographic risk) - Evaluation methods (risk-based, one or more may apply): - Questionnaire (FRM-SM-002): Standard for all suppliers - Desktop audit: Review of quality certifications and documentation - On-site audit: Required for critical suppliers (custom components, sterilization, contract manufacturers) - First article inspection and sample testing 4.2 Supplier Approval & ASL - Suppliers meeting qualification criteria are added to the Approved Supplier List (FRM-SM-003) - ASL entries include: supplier name, materials/services provided, qualification method, approval date, risk classification (Critical, Major, Minor), re-evaluation frequency - Only approved suppliers on the ASL may be used for purchase orders - Quality Manager approval required for all ASL additions and changes 4.3 Supplier Risk Classification - Critical: Sole-source, custom components, sterilization services, contract manufacturers. Annual on-site audit and quarterly performance review required. - Major: Standard components affecting device performance, calibration services. Annual desktop review and semi-annual performance review required. - Minor: Commodity materials, standard off-the-shelf components. Annual performance review required. 4.4 Purchasing Controls - Purchase orders shall include: complete specifications, quality requirements, acceptance criteria, and regulatory requirements as applicable - Changes to specifications require supplier acknowledgment and may trigger re-qualification 4.5 Incoming Inspection - All incoming materials from suppliers shall be inspected per the Incoming Inspection Plan before use in production - Inspection may be full inspection, sampling per ANSI/ASQ Z1.4, or skip-lot based on supplier performance history - Nonconforming incoming material is handled per SOP-NC-001 4.6 Supplier Performance Monitoring - Track and trend supplier performance metrics including: incoming inspection acceptance rate, on-time delivery, SCAR frequency, quality of documentation (CoC, CoA) - Generate a Supplier Scorecard (FRM-SM-004) per the defined review frequency - Review supplier performance data during Management Review 4.7 Supplier Corrective Action Requests (SCARs) - Issue a SCAR when supplier nonconformances are identified - SCARs require supplier response with root cause and corrective action within 30 days - Failure to respond or repeated nonconformances may result in supplier probation or removal from the ASL 4.8 Re-evaluation - Re-evaluate suppliers per their risk classification schedule - Re-evaluation considers: performance metrics, audit findings, SCARs, changes in certification status - Suppliers failing re-evaluation may be placed on probation or removed from the ASL

- Supplier Evaluation Form (FRM-SM-001) - Supplier Questionnaire (FRM-SM-002) - Approved Supplier List (FRM-SM-003) - Supplier Scorecards (FRM-SM-004) - Supplier audit reports - SCARs and supplier responses - Incoming inspection records

- ISO 13485:2016 Clause 7.4 Purchasing - FDA 21 CFR 820.50 Purchasing Controls - SOP-NC-001 NCR Procedure - ANSI/ASQ Z1.4 Sampling Procedures for Inspection by Attributes