The rush to develop a vaccine for COVID19 is making headlines on a daily basis. But have we asked the right questions? Let us say that a vaccine is discovered and it is proven effective. The world rejoices! We have beaten the coronavirus. Or have we? Continue reading
I am not easily impressed by technology. In fact, I am often a contrarian and don’t easily buy into the hype of the “next great thing”. It’s probably a combination of factors.
One being that I started my professional career during the 1980’s and 90’s – a period of time when there was a veritable explosion in new technology. A period of time when technology titans such as Apple, Microsoft, Intel, and Oracle (to name just a few) were born. A time when mainframes were giving way to distributed computing and the internet was coming of age. Continue reading
In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros. Continue reading
The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts involved with the ISO changes since they were proposed some years ago, even we did not know how our ISO assessors would apply the new requirements, what evidence they would expect to see, and how to pre-emptively satisfy their expectations. Continue reading
Creating a product and getting it to market is not a one-time achievement. It entails a series of ongoing cyclical processes.
It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right? Continue reading