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Innovation Award Quality Category “Sampling Plan Optimization”
- By Luis Umpierre/ Quality Engineer II
- ⋅ Ultimate Solutions
Overview
One of our Ultimate Solutions resources obtained this year 2022 the Innovation Award, in the Quality category, given by one of the main pharmaceutical companies in Puerto Rico.
The award was for the “Sampling Plan Optimization” project for Surgicel powder products. These awards recognize every year the projects executed in this pharmaceutical that have a significant impact in the categories of: Safety, Quality, Costs, etc.
In this Project “Optimization of the Sampling Plan” the areas of Finished Products and Inputs were impacted, reducing the sample size for the Yellow Index (Color), reducing the sampling from 20 to 10 per batch, incoming raw materials reducing the sampling from 167 to 45 for class I defects and from 167 to 70 for critical defects. Regulatory representation was required for review and approval prior to execution of this down sampling.
To make this possible, we worked with a multidisciplinary group made up of: Quality Engineer, Regulatory Group, Supervisor, Managers and associates. The result was an impact in the areas of Material Usage Variance (MUV), capacity and cycle time.
Our Client: Pharmaceutical in Puerto Rico
Roles
- Project Lead
- Regulatory Affair
- Process Engineer
The Challenges
Some of the challenges of the project were the failure of the data to complete the corresponding down sampling. The data collected is not robust and does not show good capacity. Additionally, we had to review CAPA/investigations to identify specific events. And finally, to obtain the approval of the FDA, MDD and BSI for national and international products.
Our Solutions
The strategy was to carry out a statistical analysis, achieve the reduction of this Sampling and avoid discarding already finished material.
Successful Results For The Client
Savings of approximately $200,000 on Surgicel powder devices in good condition and approximately $38,000 of incoming raw material saved.
Takeaways
- Next Steps: Statistical Analysis
- Technical Writing and Continues Improvement
Note: All photos used in this Case Study do not correspond to the project.
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Innovation Award Quality Category “Sampling Plan Optimization”
December 9, 2022
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