Risk Management & First Time Right

It is necessary to work “First Time Right” by preventing errors and damages, rather than repairing or inspecting. It is the responsibility of the employee to perform his work neatly and diligently, but it is the responsibility of the system (and therefore management) to minimize the possibility of making mistakes.
The best way to avoid mistakes is to take into account the mistakes that can potentially be made as early as the design phase. One approach to achieving this is Design for Excellence (DfX) and the use of Poka Yoke. One tool for conducting a risk analysis is the Design-FMEA or Process-FMEA.

‘Process Failure Mode and Effect Analysis’ (Process FMEA) is a structured risk analysis method used to identify potential failure modes in processes, products or services and to plan actions to minimize negative effects. It was one of the first systematic error analysis techniques. The Process FMEA is also known as PFMEA or FMEA for short.

Cause & Effect

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

The Process FMEA has about 12 steps:

Process Step / Items Define the process steps or components of a product.
Function Functions of a process step, product, component or system.
Specifications (Requirements) Description/requirements to be met.
Failure mode What could potentially go wrong if specifications are missing?
Impact What is the potential impact of the failure mode?
Severity (Severity) How serious is the effect on user or system?
Cause (Cause) Determine possible causes of failure mode (Ishikawa, 5Why).
Measure (Control) Measures to detect the failure mode.
Frequency (Occurrence) Probability of failure mode occurrence.
Detection. Probability of failure mode detection.
Risk Priority Number RPN = Severity × Frequency × Detection.
Improvement actions How can the product/process be improved?

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