Which is more important to you: complying with industry and federal regulations, or improving the efficiency and profitability of your operations?
It might seem disingenuous to oppose compliance and continuous improvement so starkly. After all, continuous improvement is a means of attaining quality, and compliance is a means of documenting it—two sides of the same coin. But it’s a tradeoff many manufacturers face every day. In highly regulated industries, the cost of noncompliance is often higher than the opportunity cost of incremental improvements to processes. In the course of certifying and maintaining a QMS, processes can easily become rigid, and many manufacturers leave money on the table for fear of triggering an audit or violating regulations. What I want to show here is that compliance and continuous improvement need not exist in tension, even in the most heavily regulated industries (pharmaceutical, medical device, aerospace and defense). With the technologies currently available to manufacturers, it’s possible to have both.