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Case Studies

Process Validation

Problem: The client’s proprietary process allows anodized aluminum to survive repeated medical sterilization procedures. However, there was little information documented and the procedure was not standardized. This lack of standardization led to a process window that was ill-defined which produced variable results, a high degree of rework, and customer dissatisfaction.

Solution: Through a series of designed experiments and statistical analysis, the process was reverse-engineered and standardized to ensure a robust window existed for this set of operations to be successful even though it is a manually run process.

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