Sunday, November 14, 2010

Routine Problems, Routine Explanations

Here I am at a foreign airport with time on my hands due to a significantly delayed flight. Usually I roll with the punches when travel is disrupted, and I have even grown accustomed to routine, scripted explanations. Same problems; same explanations. This time it was the ubiquitous "delayed incoming plane." The gate agent started to get annoyed when I said that “delayed plane” is a symptom, not a root cause. (It’s not her fault.)

This triggered a thought about disruptions—or more to the point—manufacturing problems that become commonplace, and routine ways I recall having seen them handled—or not.

One clever approach to handling a particular recurring deviation was to have a pre-printed form. The investigation was already written with the exception of the slight nuances, which were accommodated by blanks. This "Mad Lib" approach was completed in a matter of minutes, and a QA approval was handily secured.

Another very "efficient" approach was to use a "planned change" system to work around the recurring (planned?) problem. Another variation on this theme was an "emergency change" system used to document the quickie permission to urgently deviate from the established process—as it had many times before for the same emergency.

I would be the first to acknowledge that "things" happen, and that there needs to be a mechanism to efficiently and expeditiously handle the unusual. CGMPs would not have provided for a deviation investigation system if we lived in a perfect world.

But when the "unusual" becomes standard practice, and when quickie methods routinely substitute for permanent technical solutions, then we are buying into form over substance; ad lib over defined; accommodation over discipline; rationalization over justification. Our patients, which is to say—our business—deserve better.

Warning Letters are replete with observations about recurring problems. So, why do we tolerate habitual humans errors, aging equipment, half-baked processes, retro facilities, and uncoordinated support services that cause problems that are more predictable than our processes?

You tell me.

The best practice I've seen is the "Three Strikes You're Out." When a recurring deviation and obviously ineffective CAPA happens the third time, you no longer own the deviation/ investigation/ CAPA—your boss does. Each time thereafter, it goes up the chain of command. Now that is taking solving problem seriously—or a reaction out of frustration.

Besides, isn’t “repeat CAPA” an oxymoron?

I see the premium members queuing at the gate. I just might get stateside today.

The QA Pharm

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