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Best Practice Database
Quality, Compliance and Regulatory » Assuring Quality Programs
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Rising concerns about the quality of products and the management of the processes within the Quality function are forcing Medical Device companies to evaluate their resources and structure. As a result, supplier management protocols and the level of staff and budget allocation for different inspection activities and processes are becoming more valuable metrics to evaluate the efficiency of product release.
Best Practices, LLC conducted this study to the investigate how medical device companies manage important processes such as laboratory testing and outgoing inspections. In addition, the research presents benchmarks around the allocation of support product design and the manner in which it provides assistance across the commercialization lifecycle. The study provides meaningful metrics, such as the the optimal product mixes required at different testing levels within Quality function, coupled with key insights provided by leading executives through interviews.
Medical device leaders can use this study to evaluate their management of activities such as supplier quality and manufacturing inspections as well as the support they provide R&D.
Managing Supplier Quality & Incoming/Receiving Inspections: Most suppliers are managed by a centralized corporate group or specific manufacturing sites. A profile or self-survey is the most common supplier audit performed. Additionally, 54% of companies inspect more than 60% of incoming batches.
Managing Laboratory Testing & Scientific Quality Processes: For 43% of companies, 10% of or fewer of production batches undergo substantial analysis in an off-floor laboratory other than routine microbiology. On average, 69% of analytical lab tests and 65% of microbiology lab tests are performed at manufacturing sites.
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.