It sounds counterintuitive. After all, the whole point of regulations is to put (often rigid) rules into place to govern manufacturing processes and ultimately protect the integrity, efficacy, and safety of regulated products, such as pharmaceuticals and medical devices.
Clearly, this is a critical goal. The problem is that adherence to regulations often creates a mindset among manufacturing leaders that results in a form of tunnel vision and a reluctance to challenge the status quo. Performance improvement opportunities go overlooked. This can end up hamstringing a manufacturer’s ability to pursue process improvements that lead to breakthroughs in performance that enhance both the top and bottom line. And it can jeopardize a manufacturer’s ability to respond to changes and challenges in the industry as they arise...
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Meet the Expert
Nero Haralalka
Director, US Consulting
Nero Haralalka has extensive experience in lean manufacturing and back office process improvement. He is one of our leading subject matter experts in statistical problem solving.
