Quality Risk Management ICH Q9 & ISO 14971

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Appropriate use of quality risk management can facilitate but does not obviate industry’s obligation to comply with regulatory requirements…

Some Key Terminology

Harm: Damage to health, including the damage that can occur from loss of product quality or availability. (ICH Q9)

Hazard: The potential source of harm. (ICH Q9)

Hazardous Situation: circumstance in which people, property or the environment are exposed to one or more hazards. (ISO 14971)

Risk: The combination of the probability of occurrence of harm and the severity of that harm. (ISO 14971)

Residual Risk: Risk remaining after risk control measures have been taken. (ISO 14971)

Severity: A measure of the possible consequences of a hazard. (ISO 14971)

Detectability: The ability to discover or determine the existence, presence, or fact of a hazard. (ICH Q9)

What are the Benefits:
 Helps reduce overall cost: Supports more qualified decision making in the planning stage

 Promotes quality, through increased efficiency and knowledge transfer, with strong potential to reduce catch-up work done to mediate the effects of poor quality (ie: non-conformances, deviations/investigations, CAPA, rework, scrap, complaints, etc)

 Is an iterative and continuous process where prior risks that became problems are either mitigated or recognised and reviewed in a predictive manner for the future.

 Provides a mechanism for risk communication (formalised vehicle/process) and exposure to management

 Provides a framework to better understand processes, what is critical and why

 Helps provide rationale for not spending time on low risk activities, process events, or systems, rather focusing resources and time on the things that are really important

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Continue at: https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/ireland/quality-risk-management-ich-q9-iso-14971.pdf?sfvrsn=8

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