QSR-Compliant Purchasing Controls: A Five-Stage Plan

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QSR-Compliant Purchasing Controls
A Five-Stage Plan

You know your requirements for your supplier management program.

But what does the FDA expect? Supplier selection… specification of purchased components or services… verification of items received?

A compliant purchasing control system must have five stages:

  1. Evaluate Your Suppliers
  1. Determine the Level of Control Needed
  1. Establish and Maintain Record-Keeping Procedures
  1. Collect Purchasing Data for All Suppliers
  1. Establish and Follow Acceptance Criteria and Activities

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.

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