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Business Operations > Benchmarking and Quality

Benchmarking and Quality Best Practices

Best Practices, LLC has conducted extensive research in the field of Benchmarking and Quality. Browse through and sample our published Benchmarking and Quality research in the topics below:


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Benchmarking Medical Device Quality 2014-15: M&A Impact and Improvement ApproachesThis document contains Metrics and Graphics.This document contains Metrics and Graphics.
Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: M&A Impact and Improvement Approaches" STUDY OVERVIEW Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle. While they continually strive to ensure quality and safety in their company's products, quality leaders must also keep an eye on costs at the same time. Balancing these goals is a challenging task in today's environment of frequent mergers/acquisitions and regulatory change. To help quality leaders better deal with issues around M&A and effectiveness, Best Practices, LLC undertook this study to explore the impact of M&A and integration efforts on the quality function as well as what types of programs quality leaders are using to improve their effectiveness. 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. KEY TOPICS Acquisitions & Quality Function Integration Quality Metrics, Improvement Approaches & Controls Top Challenge Areas for Quality Organizations KEY METRICS Total acquisitions made since 2012 Number of acquisitions since 2012 that had immediate realizable revenue Percentage of acquired facilities where quality staff and systems have been fully integrated Models that best describe current and future state of your quality system Effectiveness of approaches by which quality supports rapid M&A integration Number of SOPs for quality organization at three levels Effectiveness of approaches to develop quality systems that respond rapidly to problems Effectiveness of approaches to tie quality controls to quality attributes of products Which KPIs are used in dashboard to assess quality performance Effectiveness of these metrics for determining the risk your distribution poses to quality function Current statistical confidence level for the product classes listed Top three challenges your quality function will face in next 1-2 years SAMPLE KEY FINDINGS Approaches that Improve Flexibility: Approaches most often rate “Highly Effective” are simplification, early warning systems and performance dashboards. More than half of benchmark class and large companies consider failure mode effect analysis highly effective for quality control. 56 percent of large companies and 47% of benchmark companies also find product drawings very effective for QC. METHODOLOGY 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.

Benchmarking Medical Device Quality 2014-15: Compliance and Product SupportThis document contains Metrics and Graphics.This document contains Metrics and Graphics.
Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: Compliance and Product Support" STUDY OVERVIEW Medical device organizations want the highest quality and safety standards for their company's products. At the same time, quality leaders face the dual challenge of ensuring compliance with federal guidelines and managing product support activities within tight budgets. To help quality leaders manage this challenge, Best Practices, LLC conducted a study to benchmark the role of quality in the funding and management of key compliance and product support activities at medical device companies. The study also examines how much companies are utilizing low-wage markets for quality assurance and product support activities. Research findings provide evidence-based benchmarks for quality compliance, product support and product design activities. This study contains a Large Company Segment (LCS) that is made up of 11 companies. KEY TOPICS Degree of Quality responsibility across key compliance and product support activity areas Use of offshoring and outsourcing in low-wage labor markets for Quality activities Role of Quality in product design KEY METRICS Scope of Responsibility of the Quality Organization in Compliance Compliance QA Activities Conducted at Company Sites in Low-Wage Markets Compliance QA Activities Conducted by Vendors in Low-Wage Markets Number of Objects (documents, BOMs, processes, routers, drawings) Reviewed by Quality Function % Documents Changed/Updated Change Requests Per $100 Million In Revenue Product Support Activities Conducted By Quality Function Integration of Clinical Quality into Core Quality Function Product Support QA Activities Conducted at Company Sites in Low-Wage Markets Product Support QA Activities Conducted by 3rd Party Vendors in Low-Wage Markets Extent Post Market Data Is Incorporated into NPD Design Control Budget Management Risk Management/Design Control Process Measurement Impact of Design Control Metrics on Quality Level of Integration of Risk Management/Design Control & New Product Development Systems SAMPLE KEY FINDINGS Design Control Involvement: Failure mode effects is one of the most used metrics to measure the effectiveness of risk management & design control process. LCS also heavily rely on Six Sigma standards and control standards (100% of LCS use these metrics). METHODOLOGY 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.

Benchmarking Medical Device Quality 2014-15: Nonconforming ActivitiesThis document contains Metrics and Graphics.This document contains Metrics and Graphics.
Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality 2014-15: Nonconforming Activities" STUDY OVERVIEW 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. KEY TOPICS Nonconforming Activities Additional Quality Activities KEY METRICS 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) SAMPLE KEY FINDINGS 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. METHODOLOGY 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.

 


 
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