Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: Nonconforming Activities"
Quality leaders in the medical device industry continually have to balance issues of quality and cost. Among the myriad activities associated with the quality function are dealing with nonconforming issues - deviations from standards or specifications.
Best Practices, LLC undertook this study to help quality leaders better understand the role of the the quality function regarding managing/funding key nonconforming activities. The study also addresses the level of Quality nonconforming activities conducted in low-wage markets, CAPA and NCEs ratios, and additional Quality metrics. Research findings provide evidence-based benchmarks around these issues so quality leaders can compare their efforts with industry peers.
This study contains a Large Company Segment (LCS) that is made up of 11 companies.
- Nonconforming Activities
- Additional Quality Activities
SAMPLE KEY FINDINGS
- Quality role in funding and managing key nonconforming activities
- Percentage of Quality nonconforming activities conducted at company sites in low-wage markets
- Percentage of Quality nonconforming activities conducted by third-party outsourcers in low-wage markets
- Open CAPAs and NCEs per $100M in revenue
- CAPA cycle times
- Complaints per $100M in revenue
- Field actions and field evaluations
- Quality role in funding and managing other Quality activities (corporate quality administration, M&A due diligence, others)
- Responsibilities in Nonconforming QA Activities: A large majority of participating Quality functions both fund and manage the benchmarked nonconforming QA activities. Greatest financial support goes to CAPA, complaint management, complaint investigation and MDR-MDV reporting.
- Best Practices, LLC designed and deployed a custom benchmarking survey to executives at 21 leading Medical Device companies. This study has two segments: Total Benchmark Class (TBC) made up of 21 companies and a Large Company Segment (LCS) that is made up of 11 companies.