Managing Nonconforming Product: A Devicemaker’s Guide to Compliance

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Handling nonconforming products is one of the device industry's biggest headaches.

Complying with FDA rules in the Quality Systems Regulation and international standards in ISO 13485 requires an almost Holmesian ability to dig out information and make accurate deductions.

Definitions are not clear, and requirements are scattered throughout regulations. In addition, nonconforming product management has major implications for device history records and CAPA.

This management report, based on a presentation by device systems expert Dan O'Leary, does the sleuthing and deducing for you. Pertinent regulatory passages are pulled out, interpreted and illustrated with examples from actual FDA warning letters. You'll learn:

  • Clear definitions of nonconforming product and standard dispositions;
  • The difference between correction and corrective action, as well as the types of correction applicable to nonconforming product management;
  • The device history requirements for nonconforming product rework (which you won't find in the regulations);
  • How to document and justify a decision to use a nonconforming product;
  • The importance of retesting and reevaluation after rework and the relationship to acceptance activities; and
  • How to link the investigation of nonconforming products to corrective action.

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Who Will Benefit

  • Quality Managers
  • Quality Engineers
  • Quality inspection and test managers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Regulatory affairs and compliance professionals

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