Wednesday, December 2, 2015

CAPA Corrective Action Preventive Action



There is one basic fact about life: 

We make mistakes. 

A lot of it is unintentional, but IT happens; and, when it does, it carries with it a litany of problems, that, in my world, called WASTE, the bane of existence that results to longer and costly cycle times and defects.



The International Standards Organization (ISO) requires a company to develop a formal problem identification and resolution process, which, commonly, is identified as a Corrective Action Preventive Action (CAPA), perhaps the most effective tool in logging and resolving company issues.

Of course, the goal through an effective “preventive action” is to eliminate all future troubles, the truth is that problems occur, over and over again and, with it, reasons that started them the first place. A reasonable goal is to develop a strategy that reduces replication; and, in some cases and times of development, eliminates the issues permanently.

This is where formalizing the process that logs these issues and the explanations behind them are important and necessary.

As the CAPA identifies the problem and develops steps to prevent it from occurring again, on some occasions, it requires steps to determine the root cause. A typical method used in Lean Sigma is to ask WHY five consecutive times. For example:

1.      Why is there a broken plate on the floor Bobby? Because I bumped into it.

2.      Why did you bump into it? Because I was near the table where the plate was.

3.      Why were you in the kitchen? Because I was trying to get away from Joey.

4.      Why were you running away from Joey? Because I slapped him on the head when he was playing with the tablet.

5.      Why did you slap him on the head? Because it was fun.

The answer obviously for Bobby, had he not been a normal boy, he would not have created the chain of events that resulted to the broken plate on the floor; but, as a boy at any young age, we know that he is predisposed to mischief.  That's what young children do.  It is their job to get into trouble.  As parents, it is up to us to think ways for prevention and develop controls.
First step:  Do not get upset at Bobby.

Blame NOT the person but the process or environment that resulted to the event.  What needs to happen is to build a process that controls or inhibits the behavior and makes it mistake proof (Poke-A-Yoke).  It is statistically proven, by setting up the right controls, a favorable outcome is predicted if not expected.
In the case of little Bobby, Bobby’s mother purchased a portable fence that separated the kitchen from the living room.  The barrier prevented the children from running and playing in the kitchen where the breakable plates and glasses were located.  Problem solved?  You would think, temporarily, because it is reasonable to say that kids will find ways to get into trouble.

Remember the root cause? 

"Because it was fun."

As parents, we must use our experience (remember we were once kids) and wisdom to create a safe environment and impose rules with the appropriate reminders and reinforcement.

There are other analytical root cause finding tools available; such as, story boarding, Ishikawa Fishbone analysis, and gensei genbetsu that lead to similar conclusions, but, asking WHY five times is my favorite.

CAPAs break down key categories such as environment, personnel, technology, equipment, material, timing and process to locate what’s actually the cause that created the negative effect.
To develop an effective CAPA program, this is my recommendation:

1.      Create the work instruction or standard operating procedure (SOP).

2.      Create a CAPA form.

3.      Create a Root Cause Analysis form

4.      Meet, train and in-service all employees on the concept.

5.      Solicited aggressively any and all past and present problems.

6.      Systematically measure and analyze the data

7.      Meet with key management and developed a strategy in using this information in introducing Kaizen events and steps for Continuous Improvement to effectively setup effective controls, infrastructure and policies.
Good luck!

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