Dear FDA, The Inconsistency is Killing Us

Hey FDA, you do a necessary job.  And you’re good at it.  Mostly.

But you could do a lot better.

When you inspect us, you require consistency; rightfully.  You tell us that we have to be consistent in our application of our procedures within an individual site, and between sites.

If we qualify a tabletting machine, you compare it with the documentation of the same model that we qualified last year in the suite next door.  If there are differences, you ask, “Which of these is wrong?”  Rightfully.

If we explain that we had an experienced engineer on the first project and a newbie on the second, it falls on deaf ears; rightfully.

If we whine that we had adequate resources for the first project, but there was a big lay-off before the second, it falls on deaf ears; rightfully.

I’m asking you to apply that dictum to yourselves.

Unfortunately, that doesn’t seem to be happening.  The quality and quantity of inspections is highly variable, to say the least. 

Some geographic areas get much tougher inspections than others.  Do I have data to back this up?  No.  Ask anyone in the regulated industries, though, and they’ll confirm that fact.  Your own inspectors will, too; if you ask them discreetly.

• Many inspectors uncover important gaps in our quality systems. 
• Others just skim the surface, providing little protection to consumers.
• A few only understand the veneer of quality systems.  They can find a surface blemish, but deeper problems are invisible to them.

This variability has serious costs.  Of course it means that the potential for harm to consumers may go undetected.  But that’s just the beginning.

When an inexperienced inspector focuses only on the inconsequential minutia of a complex CAPA, every eyeball in the room secretly rolls.  The essential quality improvement gets lost.  A message is received:  Compliance is only about appearance.  Valuable quality resources get diverted toward insignificant trivia.

The conscientious manufacturers will overkill their quality systems just to insure that they don’t get cited for some minor transgressions.  This costs money and delivers very little true quality. 

It drives up costs for manufacturers and, eventually, to consumers, as well.

Other manufacturers do as little as possible to get by.  They take their chances until they get caught by a good inspector.  Then they will pour resources on their quality systems for a while to cover up the problems.  Very little quality improvement is accomplished.

FDA, this variability destroys your credibility.  Did you know this is happening?  Do you care?

Well, FDA.  If the former is the case, I have a radical solution.  Survey your inspectees.  Ask them how you’re doing. 

You think that’s a crazy idea?  You think you’ll only get vindictive epithets back, if the survey is anonymous; only pablum, if they’re traceable?  I thought the same thing when I was teaching.  I thought the same thing when we got 360 reviews as a manager.

In both cases I learned painful truths about myself.  In both cases that pain made me take steps to improve.  You can do the same.  You should do the same.

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