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Process Validation Case Study: Know What You Know... and What You Don't

[fa icon="clock-o"] 12/13/16 12:29 PM [fa icon="user"] Stephen Biernacki [fa icon="folder-open'] Case Studies, process validation

About R&Q case studies: We hope this process validation case study helps you understand how we serve our medical device clients in this area. If you have specific process validation questions please contact us and we'll be happy to help. Looking to solve a different problem? Here are all of our available case studies. Subscribing to our blog is the best way to know when future case studies are available.

Case Study Medical Device Process Validation


Challenge

Transfer troubles.

A company executed site transfer and design transfer together for a newly developed product without an in-depth understanding of the product and its manufacturing process. The lack of detailed product specifications, in-depth process design, and full process validation left the program team searching for a baseline to deem the product as acceptable once the design and equipment was transferred to its new location. The result? The program experienced setbacks in implementation and found itself handling a larger-than-ideal number of nonconforming lots.

Solution

Systematically identify possible causes and take action.

Together, R&Q and the manufacturer defined and executed test plans to quickly identify the primary causes of nonconforming lots, justified changes in process and design using objective evidence, and implemented the changes - all while meeting the ever-growing market demand for the product. This work entailed not only manufacturing quality engineering and process validation, but working intimately with the product design team to identify critical-to-quality elements of the design, potential variability introduced into the product by the manufacturing process and test method, and how to implement these changes efficiently. 

Results

Production with higher assurance of manufacturing stability.

R&Q and the manufacturer seamlessly and steadily implemented the required changes through engineering reviews, process validation, test method validation, and training. The result was a quick return to production with the knowledge of root causes for the process instability that caused nonconforming lots. Ultimately, the product was returned to a state of stability, and successfully passed through FDA inspection and notified body audits.


 

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Case Study Medical Device Process Evaluation PDF

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