risk management

It is necessary to work ‘First Time Right’ by preventing errors and damages, instead of repairing and inspecting. It is the responsibility of the employee to carry out his work neatly and diligently, but it is the responsibility of the system (and therefore of the management) to minimize the possibility of making mistakes.

The best approach to prevent errors is to account for mistakes in the design phase. One way to realize this is Design for Excellence (Dxf) and the use of Poka Yoke. A tool for making a risk analysis is the Design-FMEA or Process-FMEA.

‘Process Failure Mode and Effect analysis’ (Process-FMEA) is a structured risk analysis method that is used to identify potential failures in processes, products or services and to plan actions to minimize the negative effects. It was one of the first systematic error analysis methods. The Process-FMEA is also called PFMEA or for short FMEA. Cause leads to failure can result in effect. Failure because of cause.


Cause & effect

The Process-FMEA is often used in the industry, in the high tech, but also increasingly in transactional processes. The Design-FMEA is mainly used in the development of high tech systems in the automotive industry.

The process-FMEA consists of twelve steps:

Process step / Items Decide on the process steps or components of a product
Function Functions of a process step, product, component or system
Specifications (requirements) Description / requirements that need to be met
Failure What can possibly go wrong if specifications are missing.
Effect What is the potential effect of the failure
Severity How bad is the effect for the user or system
Cause Identify possible failures (Ishikawa, 5Why)
Control Approaches to detect the failure
Occurrence Probability that there is a failure
Detection Probability that the failure is detected
Risk Priority Number RPN= severity*occurrence*detection
Improvements How can the product/process be improved?