August 22, 2023 | Mark Paradies

Bad Day: Manufacturing Issues Cost $25 Million

Pharma Manufacturing - FDA Root Cause Analysis

What Does a Bad Day Look Like? Pharma Company Missed 1st Quarter Earnings Estimate.

I was reading a quarterly report for a pharmaceutical company. They missed their 1st quarter results. Their revenue was short by $25 million. Now, that’s a bad day when you give that report to investors.

One of the major reasons for the loss was a manufacturing issue at one of their plants. The manufacturing issue was related to poor cleaning and equipment maintenance practices. Those problems resulted in an FDA warning letter.

An FDA warning letter – now that’s a bad day. Especially when your incident gets boardroom attention.

That Plant Manager is in trouble.

What Could Be Done Differently?

The cleaning and manufacturing problems could have been prevented. How? Management could have had a robust root cause analysis system and solved their problems BEFORE they received an FDA letter and missed their quarterly projections. They could have investigated the precursor incidents (there always are some), effectively fixed the root causes, and avoided the loss and the FDA warning letter.

How much of an investment is it worth to avoid a $25 million dollar revenue shortfall?

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

How much effort would it take to do a 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.

Time To Learn About Advanced RCA

Want to learn more about using root cause analysis to fix the causes of precursor incidents and avoid manufacturing and regulatory problems? Contact us by CLICKING HERE or calling 865-539-2139. Our TapRooT® Implementation Advisors 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.

TapRooT® Implementation Advisors

Or attend one of our upcoming public TapRooT® Root Cause Analysis Courses. CLICK HERE for the dates and locations.

What Does a Bad Day Look Like?
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