Change control

CHANGE CONTROL

Implementing change in a controlled way

Sometimes new insights emerge. Sometimes the market calls for something different. And sometimes, in practice, a different approach simply works better.

Change control does not start with making the adjustment, but with understanding what that change means for the product, the process, and the next steps. Not ad hoc, but controlled and well-informed, with attention to the impact on quality, tooling, validation, and serial production.

RFC & impact analysis

Every change starts with an RFC (Request for Comments). This allows us to map out what may change, why the change is being made, and what impact, risks, or consequences it may have for:

product characteristics
process settings
tooling and automation
validation and release

This provides insight into what a change means before it is implemented.

Phase-gated approval

Not every change needs to move forward immediately. That is exactly why we first look at the bigger picture. Only once the information is complete and the cause, impact, and potential consequences have been properly assessed do we determine whether the change should move into the next phase.

At ENBI, that decision point is an important part of how we work. It ensures that adjustments are not implemented in a fragmented way, but at the right time and with the right supporting evidence.

Implementation

In tooling, processes, and documentation

Only once a change has been carefully assessed is it implemented in:

tooling and process settings
work instructions and documentation
validation and control plans

This keeps adjustments traceable and processes controlled, even when circumstances change.

Verification

Against specifications and application requirements

This ensures that technical adjustments are not treated in isolation, but remain aligned with quality, validation, and serial production. This ensures that technical adjustments do not stand alone, but remain aligned with quality, validation, and series production.