Glossary
Subjectivity in Quality Risk Management
The tendency for people to perceive hazards, harms, and risks differently, and for bias, assumptions, or an unsuitable scoring scale to change the assessment.
Source · ICH Q9(R1) (2022), §5.3 Managing and Minimizing Subjectivity
Details
Subjectivity can affect every stage from risk identification to the estimation of probability, severity, and control effectiveness. Inspections take issue with vague risk questions, scores with no basis, the absence of a facilitator or cross-functional review, and bias toward a conclusion. Look at records of assumptions and bias, the scoring criteria, the sources of data and knowledge, independent review, and how dissenting views were handled.
Related sections
Related terms
Source
ICH Q9(R1) (2022), §5.3 Managing and Minimizing SubjectivityGRM Regulatory Glossary
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