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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: Staffing and Budget AllocationsThis 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: Staffing and Budget Allocations" STUDY OVERVIEW Medical device and diagnostics companies continually strive to ensure quality and safety in their company's products. But, at the same time, quality leaders must also keep an eye on costs. Balancing these goals is a challenging task, especially with the labor-intensive nature of the quality function as well as the cost-intensive activities of the quality role. Best Practices, LLC undertook this study to help quality leaders better understand quality staffing levels among their peers and the level of cost associated with key quality activities. The study includes metrics around total number of quality FTEs, past and future trends in quality staffing, span of control from managers to VPs, quality FTE cost, and allocation percentage for key quality activities. 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 Quality Staffing Levels Budget Allocation for Key Quality Activities KEY METRICS Total number of FTEs in your Quality function at the end of 2014 Percent change in Quality FTE count over past three years Quality staffing level change anticipated over next 12-24 months Average number of direct reports at each supervisory level in Quality organization Quality cost per Quality FTE Number of UPNs/SKUs per Quality FTE Number of Clinical Quality assurance FTEs Ration of clinical Quality staff to total Clinical headcount Percentage of total Quality budget allocated to critical Quality channels SAMPLE KEY FINDINGS Recent Quality Staffing Trends: Over the past three years, 57% of participants, including 56% of the LCS, saw an increase in the number of FTEs in the Quality function. The median increase was 2% (TBC) to 7% (LCS). Only one company decreased its Quality FTEs, and it was an outlier with a 27% staff reduction due to extensive process redesign. 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: Inspection and Production 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: Inspection and Production" STUDY OVERVIEW Medical device companies must produce quality products and meet compliance standards. Understanding how to balance these goals is challenging, especially with the ever-changing regulatory landscape. Undoubtedly, the quality function plays a significant role in ensuring that its organization meets these goals efficiently and effectively. Best Practices, LLC undertook this study to help quality leaders better understand inspection and compliance activities within the quality function. The study includes metrics around the level of ownership the quality function has for key inspection/production activities, the extent of inspection/production quality activities performed in low-wage markets, and supplier and software issues related to inspection and production activities. 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 Inspection/Production Activities Working with Suppliers Software Management Issue KEY METRICS Scope of Responsibility of the Quality Organization in Inspection/Production Process for Isolating Critical to Quality Parameters Inspection/Production Quality Assurance Activities Conducted at Company Sites in Low-Wage Markets Inspection/Production Quality Assurance Activities Conducted by Third-Party Vendors in Low-Wage Markets Location of Toxicology/Biocompatibility Internal Inspections Number of Active Clinical Trials Active Clinical Trials to Internal Clinical Trial Audits Number of Audits at Investigational Clinical Sites Direct Material Suppliers Per $100 Millions In Revenue Percent Incoming Batches Requiring Detailed Inspections Off-Floor Lab Testing of Production Batches Metrics Used to Assess Supply Chain Risk Effectiveness of Production Risk Metrics Document Types Reviewed by Software Quality Assurance Groups Owning Software Validation Activity SAMPLE KEY FINDINGS Compliance Leads Top Challenges: The benchmark class identified regulatory issues or compliance (24%) operations/processes/structures (24%), and talent management issues (16%) as the top three types of industry challenges facing them in the coming 12 to 24 months. 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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