Referenzen
International medical technology manufacturer – FMEA facilitation
Kategorie
FMEA
Branche
Medical technology
Unternehmen
A medical technology manufacturer based in northern Germany with around 16,000 employees
Ansprechpartner
Günter Nuss
Ausgangssituation
Development projects running in parallel; different teams specialising in mechanics, electronics, software and production; FMEA methods not applied consistently, particularly at the interface with FTA and FMEDA
Herausforderung
There was a significant need for coordination between interdisciplinary teams; the lack of a structured facilitation approach led to long lead times and a lack of transparency in risk assessment. The client was seeking a facilitator with a sound grasp of methodology and a comprehensive understanding of systems, design, processes and medical technology.
Lösungsansatz
Establishment of the FMEA structure at system level, including requirements management and coordination of mechanical, hardware and software aspects
Facilitating DFMEA and PFMEA workshops with the relevant departments
Harmonisation of the assessment framework and the structured development of effective measures
Methodology coaching for participants to ensure the reliable and consistent application of FMEA
Documentation, review and support with the approval process, including change management
Ergebnis
More efficient and effective FMEA creation; improved team collaboration (CFT); clear risk transparency, including residual risks; reduced development risks; audit-ready, structured FMEA documentation
Günter Nuss
Managing Director
