Benchmarking Quality in the Biopharmaceutical & Medical Device Sector

Industries Profiled:
Manufacturing; Medical Device; Health Care; Pharmaceutical; Diagnostic; Biotech; Consulting; Consumer Products; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
3M Company; Abbott; Abbvie; Amgen; Astellas; Baxter; Beckman Coulter; Biogen; Boston Scientific; Daiichi Sankyo; DePuy Synthes; GN Hearing; GlaxoSmithKline ; Idera Pharmaceuticals; Medtronic; Neopharm; NewLink Genetics; Novartis; Sanofi; Seracare; Tesaro; Takeda Pharmaceuticals; UCB Pharma

Study Snapshot

Best Practices, LLC engaged 23 Quality leaders from 23 pharma and medical device companies through a benchmarking survey. Qualitative data was collected via deep-dive interviews with Quality leadership teams. This report includes segmented data for pharma and medical device companies.

Key Findings

• Medical device companies are nearly twice as likely as pharma companies to rank quality integration across GxPs as a “very important” priority.
• Technology is adding value to diverse quality functions including CAPAs, complaint management, non-conforming events, vendor management, training & audit.
• Complaint patterns and on-time delivery considered most effective to determine risk of distribution.

I.	Executive Summary: Insights, Opportunities & Analysis	pgs. 3-6
	Universe of Learning: Benchmark Class	pg. 4
	Study Structure & Design	pg. 5
	Project Summary Map	pg. 6
II.	Strategic View on Quality: Adding Value	pgs. 7-28
	Quality Group’s Focus & Priorities	pgs. 9-12
	Adding Value and Balancing Risk	pgs. 13-19
	Quality Dashboard	pgs. 20-24
	Learning from Med Devices	pgs. 25-28
III.	Quality Integration Excellence across Enterprise	pgs. 29-57
	Quality Structure & Global Management	pgs. 31-34
	Digital Technology & Quality	pgs. 35-39
	Quality Management in GLP/GCP	pgs. 40-48
	Quality Management in GMP & Logistics	pgs. 49-53
	Quality Management in Pharmacovigilance	pgs. 54-57
IV.	Optimizing Staffing & Investment Levels	pgs. 58-77
	Quality Staffing	pgs. 61-68
	Quality Spend	pgs. 69-77
V.	Managing Risks	pgs. 78-96
	Supplier Quality & Supply Chain	pgs. 80-84
	Audit & Risk Evaluation	pgs. 85-88
	Corrective and Preventive Actions	pgs. 89-92
	Risk Management Metrics	pgs. 93-96
VI.	Outsourcing Excellence and Agile Quality	pgs. 97-113
	Building Agile Quality Organization	pgs. 98-104
	Outsourcing Excellence	pgs. 105-113
VII.	Demographics	pgs. 114-120

• Indicate the frequency with which your company conducts various practices associated with its Quality Governance
• Rate the Quality function’s performance in each of the following areas where Quality might contribute to your company’s overall strategy
• How important are the following objectives for your Quality organization?

• Rate your Quality function’s maturity level in each of the following areas where Quality might contribute to your company’s overall strategy
• Maturity topography map: Quality maturity level by area
• Rate the importance of each Risk Management dimension to your overall Quality strategy
• How does Quality evolve from compliance to adding value?
• Estimate what pricing premium (if any) do your major products win over your competitors due to perceived quality reputation

• Frequency of Quality communication
• Rate the effectiveness of the following Quality metrics that you use to communicate and summarize your Quality performance at the organizational dashboard level
• Key Quality indicators (KQIs) in corporate dashboards - Stratified by KQIs in pre-clinical, clinical, manufacturing, distribution, GxPs, supplier, CAPA, customer, EBITDA, patient value and new product development

• Percentage of companies that consider establishing holistic / integrated Quality approach across all GxPs “very important”
• Percentage of companies rating the following approaches “highly effective” to ensure agile Quality – Simplification of Quality design and systems and Uniform Quality technology system across all operations
• Rate the effectiveness of the following Quality audit factors in assessing and preventing various forms of GLP/GCP/GMP or PV product safety risks

• Maturity of global Quality system
• How is your company’s Quality function organized?
• Indicate the integration approach your Quality organization takes in serving your company
• Effectiveness of various listed Quality approaches to ensure global operations are safe and effective across all countries where participants do business

• Benefits produced by digital-enablement technologies
• What uses of digital technology are most promising for enhancing quality in each of the listed areas?
• Evaluate the effectiveness of digital technologies and software tools used for analyzing, visualizing, validating, managing and reporting
• What approaches to Quality data visualization seem to work best for spotting issue patterns and taking preventive or corrective actions?
• Indicate the scope and breadth of your clinical trials and development programs which Quality must help manage and support
• Revenue per clinical trial and average number of patients per clinical trial
• Total number of pre-clinical research sites and geographic distribution of pre-clinical research studies and activities
• Effectiveness of listed tools and approaches in effectively managing GCP/GLP Quality Assurance function
• Do you perform remote audits for GLP/GCP? If yes, how do you decide if an audit can be conducted remotely?
• Effectiveness of Quality practices that may be applied in the clinical research and development
• For the past 12 months, estimate the number of critical/major audit findings in clinical trials and number of deviations to research protocol
• Estimate the percentage of clinical Quality staff’s time focused on clinical development Quality Assurance activities, bioanalytical activities, non-clinical development Quality Assurance activities

• Quality indicators to inform manufacturing, distribution & CAPA/NCE performance
• Number of Quality GMP FTEs per $100M in revenue
• GMP staffing density - Number of GMP FTEs / Total Quality FTEs
• Most critical measures for manufacturing quality management
• Critical measures for distribution and logistics Quality management

• Pharmacovigilance staffing benchmarks - Number of Quality PVQA FTEs per $100M in revenue
• Highly effective factors in assessing and preventing various forms of pharmacovigilance risk
• Role played by PVQA in listed audit activities

• Factors that drive QA resource levels up or down

• Average Quality staffing ratio - Quality FTEs to Total FTEs
• Total Quality FTEs (internal + outsourced)
• Quality staffing density - Total Quality FTEs / Total FTEs
• Quality staffing allocation - Quality FTE by Area / Total Quality FTE
• Quality span of control: Estimate the average number of direct reports at each supervisory level in your Quality organization
• How has the total number of Quality FTEs changed over the past 3 years and what do you anticipate for the next three years?

• Average Quality spend ratio by segment - Quality spend to revenue
• Quality spend per $100M in revenue
• Quality as a percentage of revenue
• Quality spend allocations across functions
• Mapping Quality staffing and Quality spend zones
• Quality spend per Quality FTE
• Average revenue supported by a Quality FTE
• Examining inclusion and exclusion charges across Quality budgets

• Key drivers of Quality effectiveness across pre-clinical, development and supplier Quality functions
• Highly effective metrics in measuring supplier risk
• Most effective practices for developing strong working relationships with vendors and outsource partners
• Most valuable tools to evaluate vendor performance

• Effectiveness of the Quality audit factors in assessing and preventing various forms of GLP/GCP/GMP or PV product safety risks
• Importance of listed audit activity for assessing GLP/GCP risk and ensuring safety
• When a critical audit finding is identified, do you routinely re-audit the area in future? If yes, how soon after the closure do you re-audit?

• Number of open CAPAs and NCEs
• Highly important elements in Root Cause analysis
• Effective approaches employed to enable Quality staff in effective Root Cause analysis

• Relative effectiveness of KQIs for assessing and communicating risk performance in a corporate risk dashboard
• Effective metrics to determine production risk to the Quality function
• Effective metrics to determine distribution risk to the Quality function

• Is agility among top priorities on Quality organization’s agenda?
• Top three challenges that are preventing Quality organization from becoming more agile
• How do you assess the presence of the listed attributes that support agile Quality organization?
• Quality agility health check
• Effectiveness of listed approaches in developing Quality systems that respond rapidly to problems, issues and opportunities
• Drivers of the location of Quality centers
• Does your company employ a systematic or mature approach to isolate the most "critical to quality parameters” that spotlight select factors most significantly driving quality performance the listed systems?

• What are your insourcing (company employees) / outsourcing (vendors) mix for the listed categories?
• Number of company-run and outsourced discrete manufacturing plants
• Number of company-run and contractor-run (CMO) discrete manufacturing plants that are based in the listed regions
• Benefits / risks of working with product and service providers
• Outsourced Quality FTEs
• Quality outsourced level - Number of Outsourced Quality FTEs / Total Quality FTEs
• Impact of FTE outsourcing on Quality spend
• FTE outsourcing vs Quality FTE ratio