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You know your requirements for your supplier management program.
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But what does the FDA expect? Supplier selection… specification of purchased components or services… verification of items received?
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A compliant purchasing control system must have five stages:
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- Determine the Level of Control Needed
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- Establish and Maintain Record-Keeping Procedures
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- Collect Purchasing Data for All Suppliers
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- Establish and Follow Acceptance Criteria and Activities
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It seems simple enough, but 35 percent to 40 percent of FDA warning letters issued since 2008 target devicemakers’ supplier management systems.
Follow the five-step plan in QSR-Compliant Purchasing Controls to avoid becoming part of that statistic. This FDAnewsBrief explains what the regulation requires and how to make sure your system passes muster. You’ll learn:
- How to create a supplier hierarchy based on risk;
- The benefits of maintaining an Approved Supplier List;
- What information to keep in each supplier’s file;
- How to monitor changes in supplier procedures, personnel or products; and
- How to design acceptance procedures that ensure what you get from your supplier is what you need.
BONUS: You’ll get a rundown of recent changes in ISO 13485’s purchasing control standards along with a point-by-point comparison of QSR and ISO requirements. You’ll also receive a Supplier Evaluation and Control Checklist to help you cover all the bases.
Order Your Copy Today
PDF Edition
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Available Format |
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PDF Edition — $177
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