they make medical devices along with non regulated devices and their process is geared toward a low-regulated area.
I recon, the systems wouldnot differ whether its low/high regulated markets; what i have noticed is that the extent/depth with which the details/data is documented/recorded/supported.
The point is "process&compliance" has to be robust;
they had a quick change process that allowed them to cut parts in on a temporary basis, but this change would not change the BoM but would be tracked by work order.
what/how "good/simple" is a system which does not allow atleast traceability. usually the things which slow down is the "bringing/making all the constituents come-together & work"; and when individual roles come together they come up with respective depth/backgrounds which takes time to happen.
I am trying to tweak the process to allow flexibility but still keep firm traceability... does anyone have any pointers or key process tracking ideas to help me not slow down the company with out creating a very slow change process.
anyways,
desired flexibility can be targetted by identifying/categorizing the parts into critical/non-critical parts; which can inturn decide level/extent of diligence before performing change.
think about standardizing the checklist for each part, which will facilitate faster/quicker assessment.
