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Improving the cleaning documentation process within manufacturing environments​

Service Provided Process Optimization
Capabilities Utilized Continuous Process Optimization

Our client needed to reduce the number of manual entries by 20 percent, while ensuring successful consent decree validation.

Client challenge

The cleaning process for a Fortune 50 pharmaceutical company that was in a consent decree involved a complex workflow that resulted in regular delays, errors, and mistakes. In the cleaning of documentation records for multiple plants, there were as many as 1,500 manual fields required to complete the cleaning process. This led to a low first pass yield (44 percent), which delayed the shipment of product.

Our solution

There were too many handoffs, approvals, non-value-added steps, and wait time in the cleaning process. A lack of automation also added to excessive rework. We removed non-value-added activities and then re-wrote cleaning procedures to reduce the redundancy in steps and confusing language. This allowed us to reduce the number of manual entries needed in cleaning records by removing unnecessary checkboxes and non-value-added signatures. We then defined and created operational metrics and reporting.

Results

​Manual entries were reduced by 33 percent and cleaning hours per week by 21 percent. We also reduced approvals by more than 2,300 hours annually. The total annual cost savings as a result of the engagement was $755,000.

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