Quality risk management (QRM) is a valuable component of an effective quality system in the GxP environment. In recent years, the product life cycle approach has increasingly come to the fore, with quality risk management being used as an important decision-making and steering tool.
The risk management process is described in Guideline ICH Q9, which is firmly anchored in Part III of the EU GMP Guide. Its aim is to establish a comprehensive process of risk assessment, control and monitoring (see figure below) throughout the product life cycle, thus bringing potential errors and hazards to product quality under control. Many of these measures are identified in the course of risk analysis (e.g. FMEA) and implemented in the course of qualification and validation. In the GxP environment, one therefore often speaks of risk-based qualification and risk-based validation.
Ideally, quality risk management is already included in the planning phase (design phase) of new productions, facilities and rooms so that actions to reduce errors can be initiated at this early stage. However, a well-structured process can also bring many advantages later in ongoing productions, because all decisions that have an influence on product quality are identified and made measurable. Furthermore, this also improves the transparency of your own processes towards inspectors and auditors.
The FMEA method (FMEA = Failure Mode and Effects Analysis) is often used for risk analyses. The advantage of this method is that it can also represent very extensive considerations in a structured way. However, it can also be helpful, especially with more complex processes or plants, to first use brainstorming methods such as the Ishikawa diagram or fish bone diagram.
Depending on your wishes, we introduce together with you a complete system for your quality risk management or provide individual risk analyses, e.g. in connection with qualification and validation, measuring point analyses or your supplier management.
