TL25: Investigating Product Complaints: Pitfalls of Working with Manufacturing Data
Kate Lusczakoski, BIOVIA  *Thomas Richardson, BIOVIA  *Aaron M Spence, BIOVIA 

Keywords: Manufacturing, Missing Data, Complaints, Data Integrity, Observational Studies, Medical Device, Traceability

Complaints against consumer medical products are difficult to analyze in terms of potential influencing factors along the manufacturing process. For example, attributing complaints to device construction, product efficacy, and user error can be problematic, even prior to exploring complaint significance. Additionally, the complex nature of the manufacturing and complaint monitoring processes often requires multifaceted data manipulation techniques and mixed method analysis. Incomplete information regarding complaint events, lot traceability, and process data often plague investigations, resulting in inconclusive or incomplete findings. Furthermore, obtaining data from disparate source systems across many global manufacturing sites presents challenges associated with missing data and data integrity. This roundtable aims to discuss solutions for mitigating data fidelity issues in the manufacturing realm, as well as how existing statistical techniques developed in other life science domains (e.g. clinical trials) can be leveraged, in order to obtain faster and more robust results.

Question 1: What techniques you have adopted to assist with data aggregation and analysis when investigating manufacturing complaint issues?

Question 2: How can missing data techniques developed for clinical studies be leveraged for use in manufacturing investigations?