The Virtuous Quality Cycle: How to Start it Rolling

In our consulting work we have helped out many companies.  They span the gamut of knowledge of FDA regulations and general business experience.  Most of them are struggling with the regulations (Go figure.  That’s why they call us.)  So, if you’re struggling with regulatory compliance, you’re in a very large club.  Don’t feel bad.

There are, however, companies who are not struggling.  Not many, but we’ve seen enough of them to recognize a pattern.  These companies are rolling on a virtuous cycle of quality. 

Why would such a company need compliance consultants, like VCI?  Typically, it’s because their business is doing so well, that they NEED TO EXPAND QUICKLY to take advantage of opportunities; so quickly that their in-house quality people can’t keep up with the bulge.  So, they call us.

I said above not to feel bad if you struggle with FDA compliance.  However, you should worry about the minority of companies that are on the Virtuous Quality Cycle.  They are keeping their costs low, their quality high, and they will kill you with their speed.

When you walk in to a company that’s on the virtuous quality cycle, it’s a thing of beauty.  The first thing you notice is the c-a-l-m.  NOBODY IS RUSHING AROUND.  What you see is purposeful action.  NO WASTED MOTION.  The reason there is no wasted motion is that their business processes are designed very carefully to prevent errors.

Any errors that do creep in are identified quickly; usually by the frontline people doing the work.  Those people feel confident in alerting management to the flaw in the system, because

• THEY KNOW THEY WILL NOT GET BLAMED!
• And they know that the problem will get corrected.

That fearless workplace that the workers inhabit did not come about by accident.  Management works tirelessly to drive fear out of the workplace.

How can you hop on to the Virtuous Quality Cycle?  Start with your Quality Management System.*

1. Quality Management System (QMS).  You need a decent one.  But it doesn’t have to be great.  IT WILL BECOME GOOD, AND THEN GREAT AS THE WHEEL GETS ROLLING.
2. There is one part of your quality system that needs to work well, your CAPA system (Corrective And Preventive Action).  Why? Because CAPA is the engine that makes the wheel turn.  Each time you identify an error in your business process, you must correct it, and scour your business for similar errors that you have not yet discovered.
3. A caveat when you start a CAPA:  In your zeal to search for the root cause of an error some of the workers may feel that they are being blamed.  Management must be on the lookout and actively drive out fear.
4. The results of the CAPA are fed back to improve your QMS.  Rinse and repeat.

Every time the wheel turns, YOU ARE IMPROVING YOUR PROCESS.

Every time the wheel turns, THE TIME INTERVAL BETWEEN ERRORS INCREASES.

When error frequency decreases, you have more time to spend on process improvement and THE WHEEL TURNS FASTER.

*The policies, procedures, specifications, and processes that define how you make a quality product.

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