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Case Study: Fortune 500 Midwest Pharmaceutical Co.

Problem Statement:
Manufacturing operators using a series of mechanical push buttons to classify defects rejected by high speed vision system.  The categorized defect counts were then recorded on paper. Manual calculations and limit comparisons were then performed on the transcribed data, and then the data is was manually entered into the Manufacturing Execution System (MES) and a JMP database application.


A six-sigma project conducted in Operations revealed that a significant number of omissions and entry errors were related to the completion of these paper forms. 


  • Implement an electronic solution that would eliminate the need for manual data entry onto paper forms, and manual transcription of data into MES and JMP(a non-cGMP application).

  • Meet FDA Title 21 CFR Part 11 ER/ES regulations


  • Reduce the number of events written by Operations

  • Eliminate the need for operators to perform manual calculations on and enter results into MES and JMP

  • Remove the potential for omission errors.

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