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Supplier Quality Assurance Requires Hands-On, Risk-Based Strategy

This article was originally published in The Silver Sheet

Executive Summary

CONTROLLING THE QUALITY OF SUPPLIED PARTS AND MATERIALS can be a daunting task for device manufacturers, particularly when dealing with numerous contractors and components. Industry consultants recommend a risk-based approach to managing supplier relationships, with the most intensive evaluation and monitoring reserved for suppliers of critical parts. FDA investigators indicate that many firms are not devoting adequate attention and resources to purchasing control and incoming product acceptance activities; their observations are borne out by a steady stream of supplier-related citations in warning letters over the past couple years

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