Risk management & validation

RISK MANAGEMENT & VALIDATION

Making risks visible early

That is why we get involved early. In some cases, a DFMEA is already available from your organization or design partner. In other cases, we work together to gain a clearer understanding of where the vulnerabilities lie in the design and application. We turn that input into a PFMEA, which shows where process risks arise and what control measures are needed for stable production.

PFMEA

As a basis for process control

A PFMEA (Process Failure Mode and Effects Analysis) shows where the process becomes critical and which steps are essential to quality.

Based on this, we define:

which risks require additional controls
which parameters need to be monitored
where inspections are needed

This provides not only insight, but also direction. That is where the strength of collaboration between engineering, quality, and process expertise lies.

IQ, OQ and PQ

Validation in phases

In our role as a CMO, we go beyond performing validations. We translate jointly defined requirements into demonstrably controlled manufacturing processes. Through IQ, OQ, and PQ validation, we demonstrate that these processes operate reliably under defined conditions and deliver repeatable results.

IQ (Installation Qualification)
We verify that machines, tooling, and installations function correctly and perform as intended.
OQ (Operational Qualification)
Here, we define the process window: the settings needed to produce a good product and establish a stable process. For example: material, temperature, and pressure
PQ (Performance Qualification)
We then verify whether the process remains stable and repeatable over the long term, and how practical factors such as time, handling, and operators affect it.

Together, these steps create the foundation for reproducible output.

From validation (40)

to PPAP to production (50)

The results of risk management and validation come together in a PPAP package before serial release.

This package includes, among other things:

FMEA documentation
the control plan
MSA
measurement reports
capability evidence

This demonstrates that the product and process have not only been carefully developed, but can also be released in a validated and controlled manner.