Supplier Quality Metrics and Scorecards - Webinar Recording/Transcript

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Supplier Quality Metrics and Scorecards: A Systems Approach

The device supply chain can include hundreds of companies and stretch around the globe. Maintaining quality is a herculean task, yet the FDA requires it of you — at the risk of Forms 483, warning letters or worse.

Consultant Dan O’Leary has developed methods that substitute data for guesswork. They’re designed to support your QMS and withstand rigorous audit, as well as meet the requirements of ISO 13485:2016.

Mr. O’Leary, one of FDAnews’s most popular presenters, shares his methods in a 90-minute presentation that shows how to impose clear rules and parameters on an unruly task. You’ll discover:

  • Requirements from ISO 13485:2016 and additional guidance from the ISO 13485:2016 Handbook
  • Inspection tasks from the FDA’s QSIT
  • Audit tasks from the MDSAP Audit Model
  • Elements of a good metric
  • Incorporating predictive metrics
  • Lot acceptance switching rules as a supplier metric
  • Markers of poor performance
  • Which metrics to include in a supplier scorecard
  • How often to provide supplier scorecards
  • And much more!

Special Bonus: Recommended supplier metrics, including operational definitions, target setting and recommendations for using the metrics in re-evaluation.

Supplier quality control is one of the big challenges you face. Take the emotion and intuition out of the process, with Dan O’Leary’s systematic, scorecard-based approach.

  • Purchasing
  • Supply-chain management
  • QA/QC
  • Regulatory/compliance
  • GMP/production
  • Data analysis

Dan O’Leary, President of Ombu Enterprises LLC, has developed a highly effective systems approach to operations management that focuses on analytic skills. He boasts more than 30 years working in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.