Reduce Compliance Cost

 In Compliance, Crisis Management, Litigation, Process Development

The best way to manage recalls and other product safety and compliance crises is to avoid them. Of course, there will always be some things that remain outside of your control. But the good news is that the steps that you take to prevent product safety crises, and the same steps that will benefit you in the event that a product safety crises occurs and you are forced to manage it. This means establishing a framework of processes, integrated into the product development cycle from the very earliest stages, that facilitate a proactive approach to product safety & regulatory compliance.

So for instance in the design and development process, you need some form of “requirements engineering” that accounts not just for “regulatory” requirements (laws and regulations), but also “customer” requirements. These are your customers specifications. And they are typically incorporate regulatory requirements,  but go a level higher or more rigorous. For instance, larger sample sizes, tighter tolerances, more frequent spot checks, and so on. And in this regard the best thing that a manufacturer can do is to capture their own expertise and know how into “due care” requirements. It is almost universally true that suppliers know more about the product they supply than their customers. And orders of magnitude more than government regulators. So the lesson here is that government regulations are table stakes. The customer requirements are must haves as well and probably exceed government requirements. But true excellence is found in your own know how. Don’t fail to document it and store it in a way that the next generation of product designers and builders can learn from it and expand on it.

With requirements in place. The next key thing is to get your arms around the building, manufacturing, assembly, distribution, and shipment. There is much that can be done here as well. Materials & suppliers, manufacturing capability (variability among regions and plants), templates & control plans, and so on. From here the next step is tracking and quality processes. Monitor production, collect and analyze data, and detect problems. Another key set of processes is around problem solving. You need expertise in containing the problem so it won’t drive greater losses.

Once you have stopped the leaking, you need to get to the true root cause, otherwise nothing you do will stop the problem from recurring. Root cause analysis requires discipline. Once you determine the true root cause, the most appropriate corrective action is not that difficult to determine. And once you validate your assumptions about corrective action, you are prepared to make it happen.

Finally, despite best efforts, sometimes things will go wrong in the public eye and you have have to deal with regulators about the recall and remedy processes. This often requires some additional stakeholders with special skills related to regulatory decision making, interfacing with regulatory agencies, and communication with the public about progress.