But let’s back up a second – why are we striving for real-time? What happened to the good old days, when it was good enough just to know how we’re performing within a day? When did it become necessary to keep tabs on things so closely? The reality is that the world is simply moving faster in terms of information. Our operations are streamlined, our supply chains are bigger, our products diversified, our competition is ruthless. We move faster because if we don’t, then someone else will jump in and push us out of business. The pace of business is what keeps us moving fast, and that requires we respond to data faster. We need the data as it happens because we can’t afford not to have it.
It's a new year, and with it comes new and exciting challenges. Have you ever got that feeling when you come back from vacation and you missed something, then you scour the Internet and speak to colleagues about what you missed, and desperately try to wrap your head around what's going on? I got that feeling when I jumped into my inbox and saw this: "FDA Offers Broad New Rules to Fight Food Contamination". Well, I put my Food Safety Management hat on and started reading - here's what I think:
I've only been peripherally following the political world in the past few months. There was apparently an election I'm told, and after the election we have the Mayan apocalypse and our own apocalyptic cliff to fall off of. (I was without power for a few weeks, so all this is coming as new to me). In case you are like me, the fiscal cliff is a series of tax cuts that are set to expire at the end of the year. It also would mean that spending cuts would take effect, which would have an impact specifically on Food Safety in the United States.
There's the old saying, "Don't knock it until you try it." My daughter was convinced that broccoli was yucky, and she refused to eat it. No matter what I tried - burying it in her mashed potatoes, dousing it with maple syrup, or liquefying it and putting it in her chocolate milk - she wouldn't go for it (ok, last one was fake). Then, one day she saw her friends eating it, and they didn't seem to have a problem with it, and she decided it was time to try it again. After that day, there is no looking back - she loves broccoli, and I no longer have to fight it out with her at the dinner table.
Food Safety and Food Quality are growing topics in the industry and within regulators. Whether it’s implementing one of the GFSI schemes, getting the latest FSMA updates, or just evaluating the best practices solutions on the market, the concept of Food Safety Management is at the forefront of the discussion. It seems that with each new trend and development that comes into view, the complexity tends to grow along with it. Just for fun, let’s simplify the discussion:
There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing Recall Management. Let's face it—no one likes talking about recalls; there is no positive side to recalls, and certainly no one "wins" when a product is recalled. This is a double whammy when you are a medical device manufacturer—not only are you recalling a defective product, but you are also facing regulatory scrutiny and potential customer endangerment. So when I speak about medical device recalls, many are apt to have a system in place to manage processes in the unfortunate event of a recall. The critical factor in this case is what system is best suited to effectively and efficiently manage the recall process?
Next week (April 24, 2012 at 8:30am ET to be more specific) we will be hosting our 3rd Annual Life Science Seminar in lovely Waltham Woods in Waltham, MA (wicked lovely). This will be our third year doing this great event, and with each year, we hope to provide a venue to learn and share about the various topics in the Life Science community. This year we have speakers from EtQ, Kimberly-Clark Corporation, and Celgene Corporation.
As technology evolves, more companies are looking for easier ways to manage their IT infrastructure and, in turn, their Quality Management System (QMS). First came the client-server (thick client); then came the Web client(thin client); and now Software as a Service (SaaS) (supermodel thin client). With the first two, the key component was the hardware. It was always known that if you wanted software, you had to put it on a box, and someone had to maintain that box. In this new technological era, IT is tired of maintaining your hardware; they are looking for ways to deploy the QMS in the "cloud" - the hosted realm where server farms enable virtual operating environments to "float" and draw what bandwidth is needed to make the software work.
Last year, we all waited with anticipation when the Food Safety Modernization Act was signed. This marked an evident step forward in the regulation of Food Safety from the FDA, and many saw this as a progressive move in the right direction. We spoke on this act, and illustrated the long road ahead for regulations. It seems, however, the road is a bit longer and a bit bumpier than expected.
The title of this blog really should be "5 Things the FDA Probably Won't do for Food Safety Management in 2012."