How Do You Define Quality?

How do we know what Quality means in our business?  As quality consultants for the pharmaceutical and medical device industries, that’s a question we hear frequently.  Maybe not in so many words; but many times the question boils down to that.

“Do we have the right specifications for our product?”

“Is our fabrication process GMP compliant?”

“Will our customers be delighted?”

Our customers are constantly faced with trade-offs that pit Quality on one side and the bottom line on the other.  “We want to make a quality product, but if we spend a bunch of money on this effort, will it truly give us a Quality benefit?”

Of course when we answer that question, we have to dig deep into that customer’s unique business model.  But there always seems to be one common characteristic that lies at the foundation of any definition of Quality:  Repeatability. 

If you are questioning whether a particular project will improve the quality of your product, ask whether the result will enable you to repeat your process more reproducibly should you choose to do so.  Maybe you make a custom designed product for each sale.  But that’s not the question.  The question is whether this project will help you to repeat your process if you so choose.

Let me explain what I mean with a couple of examples. I know that you’re going to say that these examples are far removed from pharmaceuticals and medical devices.  What I say is that makes the concept even more universal.

When I was in high school my basketball coach was always yelling at me, “Howe, follow through on your shot!”

Of course I, being the skeptic that I am, asked, “Why?”

To his credit the coach explained, “You can’t control where your hand stops.  So, follow through on your shot and where your hand stops its forward motion won’t matter.  The ball is long gone.” 

Good advice, it turned out.  My shot improved after that; or rather it didn’t suck as bad.  Granted, every shot in basketball is unique.  You never repeat the same shot twice.  There’s always something different:  the opponent, time of day, sweat on the ball, etc.  Nevertheless, removing a source of variability from the shooting process makes anyone a better shooter.

Another example comes from even further afield, acting.  I was walking through a large building and came across a movie set.  There were cameras, lights, and worried looking people, all focused down a long hallway. 

An actor was walking toward us.  He stopped and looked to his right.  Then the director said, “Cut.”  He went up to the actor and said something that I couldn’t hear from where I was.  The actor walked back up the hallway and they repeated the scene, exactly like the first time.  The director said, “Cut.”  He said something to the actor and the actor walked back up the hallway.

They repeated the scene a third time, again, to my untrained eyes, identically to the first two times.  The actor walked the same way.  His expression was identical.  He turned his head exactly the same degree as before.  “Cut.”

Nothing changed, except that this time the director apparently deemed it to have been done correctly.  The crew started packing up their equipment.  There was evidently something in that last take that was different from the first two.  It was glaring to the director, but completely invisible to the clueless bystander.  When that scene appears as a 20 second segment within a movie or commercial, no-one will think twice about how much effort went into it.  The actor’s ability to repeat the action virtually identically will be completely unknown to the viewers.

Now nobody knows less about acting than I do.  But this incident tells me that the ability to repeat an action identically is critical to being a good actor. 

In both of these examples the ability to repeat a process identically is critical.  Repeatability is important in a production context because it allows you to make each item identically.  That’s critical in a regulated business because it allows you to meet your specifications reliably, reduces scrap and rework.

Beneath that, however, lies the implication of something more fundamental.  A repeatable output is a symptom of the degree of control you have over your process.

Let’s return to the original question, ‘How do we define Quality for our company?’  When the almost daily dilemma pops up, ‘Should we expend the company’s precious resources on this project that is alleged to give us better Quality?’  there is a go / no-go question that you should ask yourselves.  Does this project give us greater repeatability?

If it does, then the project may be worthwhile from a Quality perspective.  If not, then you’re probably better off moving on the next project.

How do you get better repeatability on your existing systems?  Ans.  Get all the employees motivated.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.