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# Draft Guide on Quality Risk Management
- URL: https://www.fdaweb.com/draft-guide-on-quality-risk-management/
- Published: 2022-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:48:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152076

*Federal Register* notice: FDA has made available a draft guidance for industry entitled “Q9(R1) Quality Risk Management (QRM).” The International Council for Harmonization document is a targeted revision of a 2006 guideline. It addresses four areas for improvement, including high levels of subjectivity in risk assessments and in QRM outputs; product availability risks; lack of understanding as to what constitutes formality in QRM work; and lack of clarity on risk-based decision-making. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-15/pdf/2022-12919.pdf?ref=fdaweb.com).