Japanese–English glossary
Quality risk management (QRM)
品質リスクマネジメントhinshitsu risuku manejimento
A systematic process for assessing, controlling, communicating and reviewing risks to product quality, set out in ICH Q9 and its 2023 revision, Q9(R1). MHLW issued the Japanese text of ICH Q9 as a notice in 2006, and the 2021 revision of the GMP Ministerial Ordinance made quality risk management an explicit requirement at manufacturing sites. In Japanese documents, QRM is the justification behind how tightly something is controlled: monitoring frequency, validation scope, which products go into stability monitoring. When a Japanese reviewer asks for the risk assessment (リスク評価) behind a decision, send the documented assessment. A statement that the risk is low will not be enough.