RISK MANAGEMENT METHODOLOGY

Quality risk management supports a scientific and practical approach to decision making. It 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, sometimes, detectability of the risk.

Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/or internal procedures) based on, for example, compilation of observations, trends, and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations, and allocation of resources.

In addition, the pharmaceutical industry and regulators can assess and manage risk using
recognized risk management tools and/or internal procedures (e.g., standard operating
procedures). Below is a nonexhaustive list of some of these tools (further details in Annex 1 and
section VIII):

• 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 appropriate to adapt these tools for use in specific areas pertaining to drug substance and drug product quality. Quality risk management methods and the supporting statistical tools can be used in combination (e.g., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles.

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