Quality Risk Management: Degree of formality, Formal and Informal QRM

Abstract

The International Council for Harmonization’s (ICH) Q9 (R1): Quality Risk Management (QRM) guideline made effective from May, 2023. ICH Q9’s revision provides guidance on QRM for the pharmaceutical industry and regulatory environment. It aims to improve decision-making by offering a systematic approach that complements existing quality practices and guidelines. The document emphasizes that understanding formality in quality risk management can optimize resource usage and support risk-based decision-making by reflecting the level of importance, uncertainty, and complexity of the decision.⁵ QRM is the process of appropriately managing risks to product quality throughout the product's life cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. The overall approach for determining how much formality to apply during QRM activities should be described within the quality system. In addition, subjectivity can directly affect the effectiveness of risk management activities and the decisions made. Therefore, it is important that subjectivity is managed and minimized.^1,6

Keywords: Quality Risk Management (QRM), Degree of Formality, Uncertainty, Importance, Complexity, Formal risk assessment, Informal risk assessment, QRM Techniques, QRM Tools, ICH