Process question for other users who design 1-off products.

We design and manufacture large custom machinery, with order quantities typically 1; essentially everything is a prototype. We’re also ISO 9001 and API Q1, so we have to have strict process controls, meaning ECNs are required (to some extent). During builds, the typical unforeseen issues arise (component delivery/availability issues, tolerance issues, VORs, etc) and we have to adjust drawings and BOMs to keep up with the project. I’m sure this is typical for many users here.

My question for those in the same situation: Do you generate an ECN for every one of these incremental design changes that occurs during the build? Or do you have a more efficient way to get the “prototype” built, without your designers spending half their time doing ECNs, yet staying ISO/API compliant?

If you have an efficient process, I'd love to discuss offline if you're able.

Thanks in advance