FMEA

• Moderation of FMEA
• Establishing and implementation of the FMEA methodology in the organization 

(Plato e1ns, Plato SCIO (TM) )

 

Babtec FMEA

• Moderation of FMEA 

With its manual, the VDA/AIAG provides a proven basis for the procedure. However, the description also gives scope to  focus on the main risks, their evaluation and if necessary, to minimize these risks.
 

Risikomanagement

Are you a manufacturer or supplier of medical devices? Manufacturers of medical devices must introduce or have introduced risk management in accordance with Directive 93/42/EC. I can support you:

• in the introduction of risk management according to ISO 14971
• integration of risk management into your QM system
• implementation of risk analysis
• Using of the modules from the Plato e1ns family for risk analysis

Training

As a Certified Consultant of Plato (a Peak Avenue company) for the SCIO™ and Plato e1ns product family, I offer you:

• a qualified introduction and training of the FMEA software 
• development of an efficient database for the use of lessons learned.
• Development and use of template management and organization of the template database.
• Moderation of FMEA and risk analysis with the tools of the Plato FMEA Product Family.
• Integration of the  FMEA processes into the process landscape of the company.

Tools

Plato e1ns, Plato SCIO (TM)
PLATO e1ns is the web-based Product Innovation Platform for the optimal design of the product development process. Transparent development processes, a common understanding of the system and networked cooperation provide the basis for economical, fast and successful product development – from the idea to the product. 

Babtec FMEA
The integrated solution supports you in the implementation and documentation of standard-compliant design and process FMEAs.

Automotive

Moderation of Design- and Process-FMEA:  

• Air conditioning systems
• cooling systems (motor, exhaust, thermostates)
• Operating systems (steering, climate systems, windows, …)
• Air pressure monitoring systems
• Camshaft actuator
• Oil pumps
• breaking systems
• Ignition systems 
• chassis components
• Interior

Electromechanics

Moderation of Design- and Process-FMEA:  

• men-machine-communication
• Mechatronical systems 
• ECU's
• Metal-/plastic processing
• producing-/assembling processes

Implementation / Optimization / Auditing of Quality-management-systems like
 ISO 9001

• Development and production of Industrial Controls
• Coating of elastomer profiles 

Medical

Moderation of Riskanalysis according to ISO 14971 and implementation / training of Riskmanagement according to ISO 14971 : 

• implants
• Chirurgical instruments
• Input systems for diagnostic devices
• Electronical Components for medical devices 

Implementation / Optimization / Auditing of Quality-management-systems: 

ISO 13485 Medical devices

• Development and production of electromechanical systems

Aircraft and Windcraft

 
Moderation of Design- and Process-FMEA:
Aviation

• aircraft seats
• Interior

Wind power:

• Drive components of wind turbines 
• Manufacturing and assembly processes of large components

Implementation / Optimization Quality-management-systems:
ISO 9001, 14001, 9100 

• Development and manufacture of aircraft seats
• transport systems for aircrafts