Quality Management & Performance: Conducting Audits and Handling Complaints/Corrections for Medical Device Companies

STUDY OVERVIEW

The Quality function continues to grow and have a large influence at every stage of the product life cycle. Additionally, Medical Device companies are beginning to add more resources and emphasis on maintaining quality standards on a global level. Consequently, leaders within the quality function are trying to streamline complaint management and standardize processes such as Management Reviews in order to increase organizational efficiency.

Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure and roles of the Quality function at medical device companies. More specifically, the research benchmarked the standardization of quality management reviews, the volume of complaints processed by the function, and the auditing system of leading Medical Device and Technology companies. The research also highlights the number of Corrections and Removals companies handle each year and the dynamic between managing CAPAs and NCEs.

Medical device leaders can use this study to compare their auditing processes as well as the way they manage complaints and resolution activities.


KEY TOPICS

• Executive Summary
• Employing Quality Audits & Management
• Complaint Management & Resolution Activities
• Managing NCE Activity
• Managing Corrections & Removals

• Standardization of Quality Management Reviews at different levels
• Frequency of Quality Management Reviews at different levels
• Number of person-hours of Internal Quality Audits performed for each site
• Company usage of third party auditing firms
• Number of audits that external regulatory authorities perform on organization's sites
• Organizational model for internal auditors
• Number of resources per individual spent on internal and quality audit activities
• Percentage of budget and FTE resources dedicated to Complaint Handling Activities
• Number of sites used for complaint management activities
• Structure of the medical device complaint handling operation
• Percentage of complaint handling functions executed off-shore
• Number of calls taken by patients each year
• Percentage of total inbound calls handled by self-service, automated or recorded systems
• Percentage of budget and FTE resources dedicated to Nonconforming Event Activities
• Centralization of NCE/CAPA tracking and follow-up
• Percentage of NCE tracking and reporting executed off-shore
• Annual number of NCEs and CAPAs encountered each year
  

Employing Quality Audits & Management Reviews: Across manufacturing sites, business units/division, and corporate levels, Quality Management Reviews tend to be quarterly. On average, more than 2,000 person hours of internal quality audits occur at each site. Per billion dollars in revenue, external regulatory authorities conduct 15 site-level audits on average.

Managing Nonconforming Event (NCE) Activities: Tracking and reporting for NCEs/CAPA is mostly centralized and 70% do not offshore these activities. Companies average 435 CAPA and 41 NCEs annually per billion dollars in revenue.

METHODOLOGY

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.

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