Operations and Maintenance Best Practices
Best Practices, LLC has conducted extensive research in the field of Operations and Maintenance. Browse through and sample our published Operations and Maintenance research in the topics below:
| |  | Quality Staffing & Performance: Managing Cost, Structure and Staffing for Medical Device Companies  
Non-members: Click here to review a complimentary excerpt from "Quality Staffing & Performance: Managing Cost, Structure and Staffing for Medical Device Companies"
STUDY OVERVIEW
Medical Device and Medical Technology companies often devote significant resources to ensuring that their products meet quality standards and regulations at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market activity. Consequently, optimal resource levels, staffing, and structure can help quality function leaders in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth and sustainability.
Best Practices, LLC conducted this benchmarking study to provide insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.
The study also contains insights from five medical device leaders around the quality function and its future direction. Medical device leaders in quality or a related function can use this study to compare their spend and FTE levels as well as their organizational responsibility with those of leading companies.
KEY TOPICS
Executive Summary
Quality Organization Cost & Staffing
Quality Organization Structure
Quality Systems
Future Directions of Quality Organization
SAMPLE KEY METRICS
Number of products on the market, Class I, II and III
Regions in which medical devices directly sold and sold through a distributor
Percentage of medical device revenue from outside the United States
Total cost of Quality function for medical devices and related services
Number of FTEs working on medical devices and related services within the Quality function
Percentage of Quality function budget allocated to critical Quality sub-groups/ processes
Organizational structure of quality function
Number of direct reports for a dedicated Quality employee at each level
Responsibility allocation for tracking the risk of specific products through the lifecycle
Expectations for staffing within the Quality function the next three years
SAMPLE KEY FINDINGS
Quality Structure: Almost half, or 45%, of benchmarked Quality function structures are Distributed-Quality Centric. Only 18% of the benchmark class reported a Business-Unit Centric function.
Future Directions for the Quality Organization: Only 9% of benchmark companies expect staffing to decrease substantially in the next three years. Regulatory scrutiny is expected to increase substantially. Critical success drivers for the future Quality function will focus on having adequate resources, the impact of proposed regulations, achieving improved performance, and implementing better tools.
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.
Quality Management & Performance: Conducting Audits and Handling Complaints/Corrections for Medical Device Companies
Non-members: Click here to review a complimentary excerpt from "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
SAMPLE KEY METRICS
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
SAMPLE KEY FINDINGS
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.
Crisis Management & Business Continuity Excellence: Assessing Structure, Training and Risk for BioPharma Manufacturing and Supply Chain Operations
Non-members: Click here to review a complimentary excerpt from "Crisis Management & Business Continuity Excellence: Assessing Structure, Training and Risk for BioPharma Manufacturing and Supply Chain Operations"
STUDY OVERVIEW
Crisis Management & Business Continuity have claimed urgent new attention in the global BioPharma and Medical Device sector. After witnessing devastating events -- such as Japan’s triple-punch disaster in 2011 (earthquake, tsunami and partial nuclear meltdown) that disrupted global supply chain and manufacturing plants in Japan -- many companies are anxiously revisiting their disaster recovery plans.
Best Practices, LLC conducted this study to assess how world-class companies optimize their Business Continuity preparations as well as respond when faced with major disasters or operating disruptions. More specifically, the research is designed to help participating companies develop an evidence-based understanding of how other companies plan, prevent, prepare and respond to threats to their supply chains and operations. The study includes benchmarks around structure and leadership of this function as well as different tactics surround emergency response.
KEY TOPICS
Structure & Leadership
Emergency Response: Building Capabilities to Respond Quickly & Effectively Throughout Your "Ecosystem"
Assessing Risks & Prioritizing Response
SAMPLE KEY METRICS
Steps taken to strengthen Enterprise Risk Management
Key functions where Business Continuity group reports
Structure of business continuity leadership group
Job title that leads Business Continuity function
Highest job title level to which Business Continuity function reports
Percentage of capital expense plan spend devoted to Business Continuity projects and investments
Frequency of emergency response training for key operations groups
Percentage of total operations staff undergoing response/crisis management training
Frequency of emergency response drills for ensuring successful emergency management and business continuity
Effectiveness of different improvement actions / programs to enhance business continuity and risk management readiness
Methods employed to stress test and inform business continuity plans
Approaches employed for staffing an emergency or disaster response
Effectiveness of different approaches for avoiding emergency outages and disasters
Effectiveness of various technology / software approaches that support business sustainability
Level of importance of different elements to business continuity / crisis management plan
SAMPLE KEY FINDING
Centralization/ Fast Response: Business continuity embraces centralized structures that support fast decision-making. However, disruptions occur in field & operations. Develop fast response capabilities throughout enterprise.
The Supply Chain Can Be Disrupted in Many Ways: Natural disasters are not the only threat to a company’s supply of medical products to the market and its customers. Disruptions range widely from parts to material purity to manufacturing. Small disruptions can disrupt or shut down supply chains.
METHODOLOGY
The research is based on the insights of 33 Business Continuity (BC) leaders from 29 national and global health care organizations. In addition, selected executives provided qualitative insights through deep-dive interviews and “lessons learned” observations.
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