Quality Metrics Pilot Program

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The Quality Metrics Wave 2 Report has been published!

ISPE, in cooperation with McKinsey and Company and 21 participating companies, designed and undertook an extensive Pilot Program from 2014 – 2016 to test the feasibility of collecting and reporting a standardized set of quality metrics. The ISPE Quality Metrics Pilot Program Wave 2 Report provides a further understanding of the relationships first reported in the ISPE Quality Metrics Pilot Wave 1 Report. In the Wave 2 pilot:

  • Samples sizes increased across all technologies giving good representation in all technologies
  • More understanding of the use of process capability/performance measures was obtained
  • Quality culture was explored more deeply

During the planning of the Wave 2 pilot, the USFDA issued its “Request for Quality Metrics” FRN and Draft Guidance. The Wave 2 pilot was adjusted to include:

  • Testing the proposed FDA metrics as well as testing alternative definitions applied to the FDA Draft Guidance metrics
  • Evaluating the logistics and effort of gathering data at a product-application level

The ISPE Quality Metrics Pilot Program Wave 2 Report provides an in-depth understanding of:

  • Which metrics and definitions exhibited relationships with quality outcomes - and which did not
  • The actual efforts required to collect FDA Draft Guidance metrics as compared to those given in the Federal Register Notice (FRN).
  • Experiential learnings and success factors to apply to your own quality metrics program

Download the Quality Metrics Wave 2 Report today!


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