Quality Metrics Pilot Program

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ISPE will continue its Quality Metrics Program Initiative with a Pilot, Wave 2 study.

The goal of the pilot is to inform continued industry input to FDA and to facilitate ongoing objective data driven dialogue with the FDA on the Quality Metrics initiative

The Wave 2 Pilot Program is based on findings from Wave 1 Pilot, which concluded with “A Report from Pilot Project – Wave 1” issued on 1 June 2015)

Wave 2 will provide a platform to continue refining the set of “critical few” metrics identified in Wave 1 and to further the development of a possible industry led “work space” for common metrics standards and benchmarking.

Interested in participating in the Quality Metrics Pilot Program? Review the frequently asked questions about the pilot program.

About the Quality Metrics Pilot Wave 2

Wave 2 will follow the successful process applied to Wave 1:

  • McKinsey & Company will collect and analyze the identified data confidentially, share individual benchmarking results with participating companies, perform industry-wide sophisticated data mining and analyses to derive insights from the data that are relevant for all participants.
  • Wave 2 data will be collected between July 2015 and November 2015 will largely be a one-time effort.
  • Preliminary discussion with interested companies starts 15 June 2015.

We are particularly interested in recruiting:

  • Smaller companies
  • Companies with more complex technology, e.g., aseptic manufacturing, controlled release, biologicals
  • Contract manufacturing organizations
  • Companies in emerging markets

Targeted Objectives for Wave 2

  • Extend data set to enhance understanding of relationships as further evidence of the benefit of focusing on the “critical few” measures
    • Increase the number of sites, technologies and geographies represented
    • Continue building data for targeted metric set (or refined set based on FDA input)
    • Collect data over a longer time to examine trending patterns
  • Evaluate logistics and effort of gathering product data at an application level
  • Continue to develop measures, tools, and dialogue related to quality culture and process capability
    • Facilitate ongoing industry self-development and assessment
  • Enable continued objective data-driven dialogue with FDA and other health authorities
    • Move in parallel with FDA
    • Provide further insights to inform FDA decisions during the commentary and safe harbor period

 

Benefits for New Participants

  • Develop an early understanding of a site’s performance on these metrics relative to industry peers and create potential to improve performance through better transparency (“what gets measured, gets done”)
  • Influence an industry quality metrics program design and outcome by providing feedback during the pilot on metrics definitions and frequency, culture indicators, burden estimate and other elements
  • Inform the selection of small set of metrics for the FDA Quality Metrics Initiative (during or after commentary period), by providing input on metrics definitions based on actual experience
  • Begin setting up internal processes and systems to ensure you can easily collect data for these metrics and harmonize your internal metrics definitions
  • Understand the feasibility and burden involved in tracking the updated set of metrics including data collected at product application level along the full supply chain
  • Gain insight into implications for metric implementation; facilitate change management dialogue with internal stakeholders

Benefits for Wave 1 Participants

  • Build upon the Wave 1 insights of your site’s performance and create potential to improve performance through better transparency (“what gets measured, gets done”) through:
    • Trending on the Wave 1 metrics over a longer period
    • Benchmarking performance on the new Wave 2 metrics
    • Deeper culture analysis through a set of quality culture indicators
    • Further perspectives on state of the industry application of process capability measures
  • Support the development of common metrics and definitions for the industry by providing feedback on implications during and after the pilot
  • Enable the ongoing dialogue between ISPE and FDA and provide further input to inform the selection of small set of metrics for the FDA Quality Metrics Initiative
  • Continue to set up internal processes and systems to ensure you understand the feasibility and burden involved in tracking the updated set of metrics including data collected at product application level along the full supply chain

For more information, please contact ISPE at QualityMetrics@ispe.org or McKinsey at ispe_pilot@mckinsey.com.

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