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Products & Services Quality, Compliance and Regulatory Assuring Quality Programs

Benchmarking Medical Device Quality: The Global Role of Quality in Compliance and Non-Conforming Activities

ID: 5244


Features:

5 Info Graphics

35 Data Graphics

400+ Metrics


Pages/Slides: 51


Published: Pre-2014


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Benchmarking Medical Device Quality: The Global Role of Quality in Compliance and Non-Conforming Activities"

STUDY OVERVIEW

Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are continually evaluating their group's role in compliance and non-conforming activities. Likewise, a quality group's efficiency with handling CAPAs and complaints in general are key measures of effectiveness.

This study presents benchmarks around the role of quality in compliance and non-conforming activities, including those taking place at company sites in low-cost areas of the world. The research also includes ratios around complaints and cycle times for CAPAs.

This study includes a Large Company and a Total Benchmark Class segment

KEY TOPICS

  • Compliance Activities for Quality Across Global Markets
  • Non-Conforming Activities for Quality Across Global Markets
  • Cycle Times for CAPAs
  • Complaints and Using Virtual Reviews/Automation
  • Universe of Learning: Key Demographics of Participating Companies

SAMPLE KEY METRICS
  • Role of Quality Across Six Key Compliance Processes
  • Role of Quality Across Six Key Compliance Processes in Low-Wage Markets at Company Sites and by Third-Party Vendors
  • Estimate of Objects (BOMs, etc.) Received by Quality Function
  • Percentage of Company's Released and Effective Documents That Were Changed or Updated in 2012
  • Number of Change Requests or Engineering Change Orders Your Quality Organization Assesses Per Year
  • Role of Quality Across Eight Key Non-Conforming Processes
  • Role of Quality Across Eight Key Non-Conforming Processes in Low-Wage Markets at Company Sites and by Third-Party Vendors
  • Number of Corrections and Removals/Field Actions in Past Year
  • Average Time (in days) for CAPA Cycle Times
  • Number of Complaints Received by Company in Past Year
  • Complaints Per $100 Million in Revenue
  • To What Extent Does Your Company Utilize Virtual Inspections(Photos or Video) to Determine Root Cause of Product Complaints
  • Role of Quality Across Seven Additional Process Areas
  • Role of Quality Across Seven Additional Process Areas in Low-Wage Markets at Company Sites and by Third-Party Vendors
  • Number of Events (CAPAs and NCIs) Currently Open at Your Company)
SAMPLE KEY FINDING
  • Complaints/$100 Million in 2012 Revenue: On average, benchmarked companies handled about 1,999 complaints per $100 million in corporate revenue during the last year. To determine root cause of product issues and complaints, benchmark partners at 64% of companies use virtual inspection (such as photos and videos). However, only 9% use these extensively in complaint resolution. In the large company segment, all companies use virtual review, with 17% using it extensively.
  • Responsibilities in Additional Quality Activities: Additional process areas where Quality often leads (82% of companies) include Quality Project Time and Corporate Quality Administration. The Quality function most often plays a support role in Continuous Improvement, Six Sigma, and M&A Due Diligence. Many participants in the large company segment use company sites in low-wage markets to conduct additional activities, with 40% using these sites for a majority of Six Sigma, Continuous Improvement, Management Time, Quality Project and Non-Quality Project Time activities. All the large company participants make some use of third-party vendors for Continuous Improvement projects.
METHODOLOGY
Best Practices, LLC engaged 12 medical device organizations in this research. Nearly half of the participants serve as vice presidents in Quality. Eleven of the 12 benchmark companies are based in the United States.

Industries Profiled:
Manufacturing; Medical Device


Companies Profiled:
3M Company; KCI; BARD; Cochlear; Boston Scientific; Lake Region Medical; Edwards Lifesciences; Stryker Neurovascular; Medtronic; UreSil; Terumo Corporation; WelchAllyn

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.