Major Characteristic specification limits of a popular brand were 3% and 4%. Product lower than 3% lacked consumer appeal, and product greater than 4% had reduced shelf life. The analytical method variation, expressed as plus or minus two standard deviations, occupied 40% of the specification range. As a result of this high method variability, some in-specification batches were rejected, and some out-of-specification batches were released to the marketplace. Batch rejection resulted in scrap and rework, while releasing out-of-specification product sparked consumer complaints and probably loss of sales. "What to do?" wondered the technical specialist.
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