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Risk Management Testo Industrial Services




Risk management: Risk-based qualification and validation

Definition, principles and objectives of risk management

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.

Definition of risk management

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.

Principles of risk management

  • The assessment of quality risks should be based on scientific evidence and always be seen in the context of patient protection
  • The level of effort, formalities and documentation of the quality risk management process should be appropriate to the level of risk


Risk management objectives

  • Weaknesses and risks regarding product quality and patient safety are to be uncovered
  • Decisions should be made rationally and comprehensibly
  • Quality control and steering measures should be defined on the basis of risk
  • Interdisciplinary exchange for improved risk identification should be promoted
  • Errors should be avoided or controlled proactively and preventively
  • Decision-making processes become transparent for all those involved, e.g. also vis-à-vis authorities

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.

FMEA: The preferred method for risk analysis

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.

In this way we at Testo Industrial Services support you in risk management:

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.


Fields of application & know-how

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