May 9, 2019 | Mark Paradies

Manufacturing Issues Need Root Cause Analysis

I was reading a quarterly report for a pharmaceutical manufacturing company. They missed their 1st quarter results. Their revenue was short by $25 million.

One of the major reasons was that they had manufacturing problems at a plant. Part of that manufacturing issue was cleaning issues and equipment maintenance practices that resulted in an FDA warning letter.

Now that’s a bad day. When your incident gets boardroom attention, the plant manager is in trouble.

What could have they done differently? They could have had robust root cause analysis and solved their problems BEFORE they received an FDA letter and missed their quarterly projections.

How much is it worth spending to avoid a $25 million dollar revenue shortfall?

How much is it worth spending to avoid an FDA warning letter?

How much effort would it take to do good root cause analysis of precursor incidents?

The corrective action for these precursor incidents could have prevented the manufacturing problems and would have stopped a major portion of the $25 million loss.

Want to find out more about using root cause analysis to fix the causes of precursor incidents an avoid manufacturing and regulatory problems? Contact us by CLICKING HERE or calling 865-539-2139. We know how to help you implement advanced root cause analysis and stop problems BEFORE they become major issues that get the board of directors’ attention.


Accident, Root Cause Analysis
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