An ounce of prevention is worth... well, you know

Need to catch up? You can read the entire series here.

At long last, you've completed your analysis, and you're ready to talk CAPA (that's Corrective and Preventative Action, in case you didn't know). Before we begin, I have six words of caution for you: take one thing at a time. You may have several strong root causes that you want to eliminate; however, I recommend that you start with one. If you implement multiple CAPAs for multiple root causes, it's going to be difficult to gauge the effectiveness of each CAPA.

The term CAPA, although it's used as a single entity, refers to two different activities: corrective action and preventative action are not synonyms. Corrective action is problem-solving; it's fixing the immediate issue, and is often completed fairly quickly. For example, if you look at the order entry error I used as an example in an earlier entry, the corrective actions might be:

1. Apologize to the customer for the inconvenience.
2. Issue a credit for the amount overshipped.
3. Arrange for a freight carrier to retrieve the overshipped product and return it to your facility.

And just like that, problem solved. However, you've done nothing to keep the problem from happening again. That's where preventative actions come in. In our example, we concluded that the root cause of this error was the mistaken belief that "everyone" knows that we have to specify the unit of measure on the order entry form, and therefore it's unnecessary to modify the form to request the unit of measure.

Many businesses would suggest that the solution to this problem is simple: train all the employees so that our assumption that "everybody knows" becomes fact. Well, that's probably not the best answer, unless you want to re-train every time someone forgets (and they will), or with each new hire. Mind you, I'm a training professional, so it irritates me no end when folks think that training is the answer to every performance problem. Trust me, it's not.

So how do we prevent this from happening again? You need to think about systems; not software systems, necessarily (although sometimes a software modification is in order), but business systems. Once again, your team members need to leave their egos at the door. This is the time for management to 'fess up and admit that they've contributed to the problem by creating a system in which it's easy to perform the task improperly, and difficult to perform it correctly. If you're a manager, your goal should be to help your employees succeed by making it easy to do their jobs correctly, and difficult to do them incorrectly. Only after you've helped remove their obstacles to good performance can you reasonably hold them accountable.

You'll identify CAPAs in the same way you identified possible causes: brainstorming. If you were able to score the "fixable" quotient of the cause, then you've probably thought of possible CAPAs as part of that process. Now you'll flesh them out a bit more. When you're developing CAPA, there are a few questions you'll want to answer:

• Who owns the change(s) we're putting in place?
• Whose jobs will be impacted by the change(s), and to what degree? How do we communicate the change(s)?
• Do we need additional resources (human or capital) to effect the change(s)?
• Who will resist the change(s), and how can we overcome that resistance?
• How much will the change(s) cost, and how long will implementation take?

And the most important question of all: how will we know if the CAPA(s) work?

Tomorrow I'll post this week's favorites; Monday I'll cover monitoring CAPAs and documentation, and I'll finally wrap up this series on Tuesday. Have a great evening!

Comments

[Bill Wilson]

Hi Kathleen,

I just found this series of articles on RCA and I'm really enjoying them. Keep up the good work!

Regards,
Bill Wilson