Determine the root cause

Determine the root cause

Determining the root cause is important to prevent recurrence of quality problems.
If the root cause cannot be determined, the problem will recur.
The author has been providing consultation on CAPA for many years and feels that too many companies do not understand the difference between correction and rectification.
Correction” means to destroy the immediate cause, while “rectification” means to destroy the root cause.
A “fix” can fix the problem, but it cannot prevent its recurrence.
Let’s say, for example, a washing machine hose rips open and leaks water.
The “fix” is to put tape over the tear in the hose to stop the leak.
However, if only “correction” is made and not “remediation,” the possibility of recurrence remains.
In “corrective action,” one must seek the root cause. In the above case, the hose may have been subjected to a strong force. Or perhaps the angle of installation was too deep. More likely, there was a problem with the material, manufacture, or design of the hose by the manufacturer.
If those root causes are not identified and destroyed, they will recur.

In the course of my consultations with pharmaceutical and medical device companies, I often review CAPA records.
However, the root causes are often not fully investigated.
In most cases, the cause of the problem is superficial and not fully investigated.
In other words, the “correction” is done but the “correction” is not.
From many years of experience, the author intuitively senses a possible recurrence when he sees a CAPA. When asked to search for quality information, as expected, there are a small number of recurrences.

Determining root causes requires skill, experience and insight. It will be difficult to do overnight.
In other words, it is necessarily difficult to determine the root cause simply by creating CAPA procedures and implementing a set of training programs.
It is necessary to perform CAPA repeatedly and acquire sufficient logical thinking.

CAPA implementation that has become a mere formality will not lead to improvement. The idea of simply making corrections must also be abandoned.
This is because in the manufacture and sale of pharmaceuticals and medical devices, recurrence of problems must be reduced as much as possible.

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