#61 – CAPA -ABILITY – UMBERTO TUNESI

Umberto Tunesi pixWe all know what the acronym CAPA means in the quality and risk management business.  And if there’s a word of the day, CAPA is probably it.

To the point that it seems we’ve become almost obsessed with CAPA’s.  While looking at them objectively, they’re the outputs of very simple, logical, natural processes.

We’re all bound to make mistakes.   They say that perfection does not belong to this world and they’re probably right.

Whatever we do, say, write, or think, the timing of perfection is subject to what we call mistakes, or errors.

Pity that we become aware of the mishaps after the event has occurred.

Though it is not always so.  In many cases, we feel that what we are going to do say, write, etcetera will result in undesired outputs.

There are therefore two basic questions we should try to answer, well before jumping to deploy a CAPA process:

  1. We have to be aware of the fact that we will make mistakes and accept it.
  2. We’ve also to be aware that what we call our sixth sense can lead us on the right way.

As far as the CAPA process is concerned, I think that there’s not much to say about it,  Certainly mistakes have to be corrected, to the extent that they can be corrected.  Hurting a person’s feelings is obviously not the same mistake as identifying the wrong size of a bolt.

Preventive Actions (PA’s) have a more ambiguous nature in the sense that we would like them to guide our processes.  Whatever they are, but we usually think of them when it’s too late, that is, when we’ve to put Corrective Actions (CA’s) in place.

PA’s are therefore totally ineffective with the exception of very few cases.

LEARNING PROCESSES
Please see below my comments on learning processes.

Let’s take dental care, as an instance.  We were told since we were children what’s good for our teeth and what is not.  But we kept ignoring these lessons until it was too late and we had to go to a very expensive dentist, who told us exactly the same things.  But we ignored him, too, so we started getting into worse and worse dental troubles.

This represents how the CAPA process is usually managed.

We can make presentations, show luring slides and figures.  The really effective CAPA management process is not in front of our eyes but between our ears, that is in our brain.

My step-son will be 27 on next September 2.  His friends, boys and girls, are often our guests.  They’re all university graduates.  Most of them work and live abroad.

When I speak with them about a productive approach to correcting a preventing mistakes/errors they look at me as if I came from Mars.

They haven’t the faintest idea of what fail-safing can mean,  Though those of them who play tennis know very well the meaning of a wrong shot.

This is also the prevailing attitude among quality and risk management professionals: they think they know but they don’t put their knowledge at test.

Is there any viable solution to the CAPA process effectiveness dilemma?

I think there’s more than one, provided we look at it differently in a less conventional way.

CAPA scenarios are not always the same.  Actors and circumstances are ever changing.   CAPA procedures can therefore be only very generic to the point that common sense may well replace them.

We’ve made a fixed point of the principle “lesson to be learned”: but whoever cares to learn the lesson?  And how would he learn it?

Learning processes are no easy thing at all but they’re implicitly the basis of the PA process.

There are some fundamentals to the CAPA process that have to be defined, implemented, tested and validated before starting the CAPA process itself.

If we don’t act this way, we may well find ourselves having to CAPA our CAPA process …

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