Be Better Than the Best


It-s-not-about-being-the-best-It-s-about-being-better-than-you-were-yesterday-367When I was in college, the robotics club held a fund raiser selling t-shirts that said “INNOVATION” – in all caps and BOLD lettering.  I bought one – because I was so sure that someday, I would invent something that would change everything, for everyone.

To date, I have not realized that dream.  I haven’t revolutionized anything.  I haven’t invented a new drug, or cured a disease.  Instead I have spent more than two decades working in QA.  I do like to think though, that in that role, I help make the inventions of other people readily and safely available to the people that need them.

I still have my faded “INNOVATION” t-shirt, but I also have a small plaque on my desk that says “patience” – in pale colors with italicized text.

Within regulated industries, change is rarely cutting edge.  At first glance this industry seems to reserve the privilege of innovation for medical researchers, because the post licensing phases of the pharmaceutical product lifecycle are constrained by some of the strictest regulations on the planet.  However, QA may still have a few chances to improve the world through innovation. If we are lucky, there may be an opportunity for us to replace antiquated systems and processes with newer more efficient, safer, cheaper or faster systems and processes.  But even when presented with the chance to innovate, we more frequently seek the “best practice”, which seems to ensure that nothing we put in place will actually be new.

I am continually surprised by the amount of time we spend seeking this all elusive “best practice”.  In effect, standing in line waiting for someone else to take on the front loaded risk of implementing something new, and waiting until enough people follow suit, eventually resetting the bar and redefining normal.

It occurs to me that Pharma may be the only industry that elects to employ huge numbers of mechanical, electrical, chemical, industrial and software engineers, that have been incentivized to avoid innovation.



And that’s when patience becomes the most valuable tool in the box.

Patient is what you need to be when you are sitting in a meeting listening to a dozen people describe their impression of our industry’s best practice.  Patience also comes in handy when you realize that the group is no closer to reaching consensus on the current best practice than they were six months ago.

Patience is what you practice while trying to convince the group that as they debate, all the versions of the best practice are aging; on the way to becoming other antiquated practices.

In these situations, I patiently suggest that the decision makers consider altering the language in order to alter the expectation.  To in effect, provide context to the goal.

What if, instead of focusing on “best practices”, we simply sought to implement “better practices”?

Sometimes, it’s all about language.

“Best” is a superlative – when we use it, the implication is that no thing is better – and that what is best is a particular, definable, singular thing.  If we make such a claim, we also imply that we have evaluated every other similar thing, compared it to our singular thing, and found all the others, lacking.

In my humble opinion – expecting a project at your workplace to begin by defining and specifying a best practice is setting the stage for failure.  Resetting that stage for success can be as simple as rephrasing the language.  Ask the same group to evaluate existing systems (including weaknesses), and to propose improvements to them, and sit back and watch what happens.

Think of it this way:

  • Dropping the word “best” eliminates the perception of a singular and final solution
  • The word “better” implies improving – instead of replacing
  • Improvement implies a constant effort – a continually evolving model
  • “Continual” acknowledges that efforts to improve do not end;  understanding that there isn’t only one chance to bat reduces pressure
  • As pressure decreases, creativity and productivity increase

On the surface, it may seem as though I am recommending avoiding aiming high for fear of failure.

Not the case.  I am merely suggesting that we consider that aiming for “better” will bring more success and progress than aiming for “best”.

Let’s re-phrase again, and introduce precision in our language – in this context ”best practice” actually means “most common practice”.

I’m not so far gone from my engineering school days to assume that common means best.  In fact, don’t all innovators share the belief that common is what needs replacing?  The drive to innovate comes from the belief that common is not good enough and that no thing is best for long.

And because I’m QA, I need to consider compliance as well as progress.  When we consider the little “c” in cGMP – it seems to suggest that the pursuit of the most common practice has value, and is what FDA is expecting to see.  This may have been the case before the very public campaign FDA launched to communicate their expectation that we all strive for and demonstrate efforts toward Continual Improvement.

When considering compliance from this point of view, it becomes clear that today’s FDA also believes “better” is better than “best.”

There is no language in Title 21 or in any guidance document that I have ever read that communicates an expectation of finality or perfection, or an expectation that we all do things the same way.  In fact, the very manner in which Title 21 is structured communicates the regulators’ intent to allow us to define our own methods and practices.

How many times I wonder, is the word “demonstrate” used within Title 21?

I have no idea, but if I were forced to hazard a guess, I’d say more frequently than any other verb.  The fact that the law requires us to constantly demonstrate outcome reminds us that we have latitude with methods, processes and systems.  And the fact that we are expected to manage change, conduct periodic reviews and evaluate trends, should remind us that the regulators understand that our methods will continue to evolve.

The law is written this way to encourage innovation (or to at least avoid stagnation).  It allows us control over the definition of our processes as long as we can prove that we are in control of them, and that the outcome is reproducibly compliant with product standards, and process standards (metrics, by the way, that we also defined ourselves).

I believe FDA’s very public efforts to push us all towards Continual Improvement – have been an effort to diminish the imaginary goal that is the “best practice.”  It is their way of telling us that we have incorrectly perceived the meaning of the little “c”.  In my opinion, the little “c” was intended to be a minimum standard –to warn us all that anything less than currently common would be considered deficient, not to scare us away from anything that may be more than common.

In fact, the Quality System Regulations and the Guidance on Quality Systems make it very clear that the agency believes our compliance efforts shouldn’t end at common.

Another very clear message – it is no longer safe to assume that doing what everyone else is doing is enough.  Today, we are expected to constantly strive toward making our systems better than they were – an objective that begins with understanding the weak points and identifying where improvement is warranted and possible.

Think of it as moving to your own “next” best process, an evolution of your own model, as opposed to an importation of someone else’s.  A refinement of processes and methods and systems that should have been uniquely developed to meet the needs and take advantage of, what is unique about your company, its product and the realities encountered when the product is being manufactured.

Implementing step wise change also allows us to predict outcome and control the impact of the change effectively.  Implementing entirely new systems, rarely leaves us in a position of confidence when dealing with the challenge of controlling change.

It’s time for us to recognize that attempting to find the singular and best practice that apparently exists at someone else’s facility, is just about as useful as tilting at a windmill.

Instead, we should remember the idealistic young students we used to be, and we should set about innovating new solutions.  Solutions that have been developed with our own facilities’ challenges and our personal experiences with them in mind.  Solutions that are driven by the data we collected, and not by the data someone else collected from their systems.  And we should expect post implementation to collect more data that will continue to tell us more, prompting us to continue to improve of all our systems over time.

Try approaching improvements with your own data, mapping and creating solutions that meet your needs, and those of your customers.


Innovators don’t seek the middle, they don’t find common comforting – they have confidence in their own ideas and in their own ability.

They believe their better, is better than anyone else’s best.

Tim Duncan said:

“Good, Better, Best
Never let them rest
Until your Good is Better
and your Better is Best”

To that, we add:


“and if then you rest,

It won’t be long

Before your Best

is back to Good again”


© Coda Corp USA 2014. All rights reserved.

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Authored By:

Gina Guido-Redden

Chief Operating Officer

Coda Corp USA


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“Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives.”




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