In the world these days, we have more access to data than ever before.  Whether through social media, smartphone integration, or enterprise systems - we blur the line between what's business and what's personal.  With the enormous amount of data filtering through our brains, we instinctively look for ways to make sense of things.  We try to figure out "what's trending" - whether with celebrity gossip, sports teams, or in the case of Quality Management Systems, adverse events. 

The ability to collect adverse events and make decisions to foster improvement is the cornerstone of any Quality Management, Environmental Health & Safety or Compliance Management system.  Whether you are recording complaints, safety incidents, audit data, or nonconformances, the process of collecting data, investigating the root cause, and taking steps to correct it is consistent.

In our last episode, we looked at how the crew of the USS Enterprise and the Star Trek franchise might have employed Quality Management Systems to help streamline their processes, mitigate risks, and foster continuous improvement throughout the galaxy.  It’s only logical that you read Part 1 to get the full picture up till now.

I am by no means a “Trekkie.”  I don’t go to conventions, nor do I have all the episodes memorized and cataloged.  I don’t even try and weigh in on Picard versus Kirk (although I do have some valid points in that debate – another time).  What I do know is that no matter how much I try, I cannot seem to ignore the Quality Management side to my life, and while watching an episode of Star Trek the other day, I got to thinking about what type of QMS the USS Enterprise had during their prodigious “trek” through the stars.

I've been a bit behind on the blog posts lately, and wanted to get back into the swing of things with a few ideas on one of the most central and critical components of any Compliance System, whether Quality Management, Environmental Management or Health and Safety Management.  I'm talking about Corrective Action - CAR, C/A, CAPA - whatever you like to call it.  Psychology states that the more names we have for something, the more important it is in our society.  While society at large is not espousing the benefits of CAPA/CAR/CA/Corrective Actions, it certainly is a core piece in our business world.

We're often faced with a common conundrum in businesses when it comes to system architecture.  No matter how you try to slice it, there are always going to be silos of information within the organization.  With multiple business systems running throughout operational processes, it is a challenge to create visibility into those silos and create better visibility to the data.  Yet this is the ideal situation - business systems that can remain separate, but have integration with each other to talk and communicate, acting as one.  Lofty, but achievable - you just have to have the right tools.  One of these challenges lies in the ability to integrate a Microsoft SharePoint implementation with your Quality Management System's Document Control Solution.

I am a firm believer in the power of reality.  A broad statement for sure, but in an increasingly digital world, it is nice to actually go somewhere and talk to other humans directly.  There's something a bit more satisfying in sitting down and listening to speakers talk, taking old school notes, and talking to industry peers.  That is why I am pushing this week's post to talk about this upcoming Life Science Summit on Quality Management Systems in Bridgewater NJ this March 12th, and the 3 reasons why you should attend.

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.

As markets continue to evolve, organizations are evolving their definition of compliance.  From an operational context, the speed and level of complexity within the market is driving faster product lifecycles, more extensive and complex supply-chains, and a need to remain competitive and compliant.  For many, this task cannot be achieved through the methods of old; new benchmarks need to be implemented that have the agility and consistency to respond to market needs and make informed and logical decisions.

Aviation safety continues to be a front line discussion in the news as of late.  Most recently, safety continues to affect the 787 Dreamliner, with several airlines pulling them from rotation.  Airlines are safer than they have ever been, so when we see more headlines about safety, it draws attention.  In the public mind, safety is an effort of constant improvement - there is no acceptable level other than 100%, and airlines are tasked with that notion. Safety Management Systems (SMS) are developed with the focus on mitigating risk of occurrences within operations.  As these SMS evolve, we are seeing new trends on how companies are implementing Safety Management within their operations.