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FDA describes Quality Management Maturity assessments and seeks more volunteers
Summary
The presenter said OPQ has completed QMM assessments at 17 establishments, conducted a 2024 cohort of nine assessments, began a second cohort of nine in 2025, and solicited volunteers via a Federal Register notice to expand participation.
An FDA presenter reviewed the Quality Management Maturity (QMM) program as a way to assess and strengthen manufacturers' quality systems. He said OPQ developed a prototype assessment protocol and that a 2024 cohort of nine assessments demonstrated the protocol's ability to distinguish differences in maturity.
The presenter reported that OPQ has completed QMM assessments at 17 establishments to date and solicited volunteers in February via a Federal Register notice for additional cohorts. He encouraged voluntary participation, particularly from regions and establishments not yet represented.
