Have regulatory compliance demands overwhelmed your company—FDA, FAA and equivalent global regulatory bodies and eco-compliance initiatives like ROHS, WEEE and ELV?
You’ve got to be green to be seen! Being green is a multi-billion dollar twist in the global economy. Unfortunately the data acquisition bottleneck can prove cumbersome, and cause you to see red. Compliance, in general, boils down to declaring data and the process that produced it, and then proving it so.
Regulatory compliance is a business constraint. Reduced to fundamentals, it translates to meeting metrics with documented supporting processes. With pressure to rapidly evolve product innovations, automation again emerges as the great equalizer. But attention should be paid to core capabilities. At a minimum, your compliance toolkit for your product introduction process should include an automated supplier material specification data sheet; a ”BOM fitness” evaluator; an exception reporter; an issue escalator; and a compound report generator. Assuming you have already embraced the use of a PLM system for common, integrated product information, automating these additional functions will streamline your compliance effort.
It is likely that you engage in a high degree of outsourcing for your components, and as with most outsourcing, governance plays a key role. Deploying a system in which individual component suppliers can provide you electronic material composition records as well as test data to support their claims is the new expectation baseline. Some of this interaction will be facilitated by emerging standards. Clearly, automated exception reporting and issue escalation will support and simplify governance.
Armed with this information, a BOM fitness evaluator can analyze total concentrations as well as other constraints to optimize your product innovation process.
