We help and coordinate your team to carry out risk analysis of the processes with a structured, practical approach based on the principles of the ICH Q9 guide on Quality Risk Management. We apply recognized methodologies to identify, assess, and control risks that may affect product quality throughout its lifecycle, with the ultimate goal of protecting the patient and ensuring regulatory compliance.
Our services include:
- Identification of risks and assessment of the impact on quality.
- Estimation of the probability, severity and detectability of the risk.
- Prioritization of risks and establishment of control or mitigation measures.
- Documentation and communication of results in a clear, auditable way and aligned with regulatory expectations.
We have experience in the application of different risk analysis methodologies, adapted to the characteristics of the process or facility:
- FMEA (Failure Mode and Effects Analysis): We identify potential failure modes, their causes and effects, and propose preventive or corrective actions.
- FMECA (Failure Mode, Effects and Criticality Analysis): we extend the FMEA by incorporating criticality analysis to prioritize risks according to their severity, probability and detection capacity.
- FTA (Fault Tree Analysis): useful for deviation investigations and root cause analysis, visually representing fault chains.
- HAZOP and HACCP – applicable to complex production processes or critical areas such as aseptic manufacturing.
All of these methods can be combined or adapted depending on the complexity of the process, the level of criticality, and the resources available.
Our approach is based on applying the most appropriate tool to each situation, ensuring that the analysis is not only rigorous and in line with regulatory expectations, but also useful and practical in daily operations.
The ultimate goal is for the decisions derived from the risk analysis to be solid, justified and aligned with the operational reality of your organization.
The analyses are carried out in collaborative and multidisciplinary sessions with your team, facilitating the transfer of knowledge and commitment to the implementation of measures. In addition, we offer support in the integration of risk analysis within your quality system, including linkage with change control, validations, deviation management, and audit preparation.
Well-thought-out risk management not only improves product quality and safety, but can also optimize the use of resources, improve decision-making, and reduce the impact of potential deviations or non-conformities.