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Biological Assay Performance
Background
- Healthcare products manufacturer
- Problem Statement: Excessive Variation with destructive, tight tolerance testing
- - Unable to effectively diagnose test result
- Process for testing:
- - High intensity light passed through array wells on microtiter plates
- - Color emitted by reactions quantified by a detector
- Test set-up:
- - Plates coated for assigned application
- - 2-3 coats per test
- - Washing and drying required between different coats
Approach
- Test designed to split between inputs to the processes and the functions of the processes
- Involves same number of plates as a regular production test sample
Results
- Casual Mechanism lived in the first drying operation
- - over aggressive airflow drying caused variation
- - effective characterization of system behavior eliminated coating and washing from casual mechanisms
- Variability of production sample tests reduced from over 100% of the tolerance to under 25%
- Avoided expensive and time consuming experimental test plan that involved 14 variables, none of which we air flow
By the Numbers
2 hours
Avoided weeks of complicated and expensive testing experimentation by determining casual explanation in 2 hours
>75% Reduction
Test result variation reduction from over 100% of tolerance to under 25% of tolerance