Stronger risk management with FMEA and risk analysis

A well designed risk management process reduces documentation workload, increases efficiency and ensures product quality. This is achieved, for example, by the targeted evaluation of concepts such as Critical Quality Attributes and Critical Process Parameters. When relocating qualified GMP facilities we lower validation efforts with a relocation risk analysis and, if desired, take on project management even in time critical transfers. In addition, we derive suitable User Requirement Specifications and process parameters from Component Requirement Specifications. Our consultants combine deep GMP expertise with a risk based approach to systematically optimise development and production processes.

Preliminary Hazard Analysis and the evaluation of post market data allow early identification of potential hazards and harmful events. In client projects we first visualise relevant processes and prepare targeted workshops. The PHA evaluates the probability of occurrence and possible severity of injuries or health impacts and often triggers early improvements in product development. We also use Fault Tree Analysis to capture causes and correlations. With experience and structured facilitation we support teams in comprehensively identifying and safely managing risks.

For technically simple products we recommend moving straight to Design FMEA after the Preliminary Hazard Analysis. For more complex medical technology products or GMP facilities a preceding Functional Risk Analysis is advisable to identify hazardous functions and reduce overall effort. System FMEA also plays a central role in audits as it provides a structured view of safety relevant components. We support with prepared workshops and ensure consistent use of the methods across the team within risk based safety evidence according to MDR Annex I.

With two decades of experience in tailored risk management processes, plans and analyses the GRÜNEWALD team has built proven best practices. Using structured checklists we efficiently compare existing processes with recognised standards and identify targeted improvement opportunities. On request we also review risk files from the point of view of a Notified Body or the FDA and provide concrete guidance on gaps or deviations. We work closely with product management, development and application specialists to ensure effective and audit ready risk management.