RISK MANAGEMENT METHODOLOGY – ICH Q9

RISK MANAGEMENT METHODOLOGY – ICH Q9

Quality risk management (QRM) – a scientific and practical approach to decision-making.

QRM provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and detectability of the risk.

Quality risk management (QRM)

In general, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on,

For example,

  • The compilation of observations,
  • Trends, and
  • Other information.

QRM approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations, and allocation of resources.

In the pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and internal procedures (e.g., standard operating procedures).

Below is a non-exhaustive list of some of these tools:

  • Basic risk management facilitation methods -(flowcharts, check sheets, etc.)
  • Failure Mode Effects Analysis (FMEA)
  • Failure Mode, Effects and Criticality Analysis (FMECA)
  • Fault Tree Analysis (FTA)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Hazard Operability Analysis (HAZOP)
  • Preliminary Hazard Analysis (PHA)
  • Risk ranking and filtering
  • Supporting statistical tools

It might be applicable to adopt these tools for use in specific areas pertaining to drug substance and drug product quality.

Quality risk management procedure and the aid statistical tools can be used in combination (e.g., Probabilistic Risk Assessment).

Combined use give the flexibility that can facilitate the implementation of quality risk management principles.

The degree of rigor and formality of quality risk management should reflect on the basis of available knowledge and be commensurate with the complexity and/ or criticality of the issue to be addressed.

Reference –  ICH, QUALITY RISK MANAGEMENT, Q9 -09 November 2005

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