Benchmarking BioPharma Quality and CAPA Processes: Quality Resource Management

STUDY OVERVIEW

Biopharmaceutical companies spend millions to ensure their products meet Quality standards at every stage of the product life cycle, from R&D to post-market activity.

Facing tight budgets and escalating regulations, Quality leaders walk a tight rope in balancing quality and safety while managing costs and assessing risk. Across the myriad Quality activities, where are leaders currently spending the most? How do Quality leaders expect spend to change during the coming years across a key set of quality activities? What factors are driving cost of quality?

Research and consulting leader Best Practices, LLC undertook a new study to answer these questions and more. Topics addressed in this study include: how companies define and allocate Quality spend, and factors that impact spending levels. Leaders can use this research to compare their levels of spend across key Quality areas with their peers.

This study presents two segments on some questions: All Participants and Large Companies

KEY TOPICS

• Quality Spend Levels and Trends
• Quality Spend Mix
• Quality Reporting and Ownership
• Quality Spend Drivers
• Best Practices for a Robust Quality Function

• Percentage of total quality function budget allocated to these critical quality channels (compliance, nonconforming, etc.)
• Expected change in allocations to quality budget for these key channels (compliance, nonconforming, etc.)
• Total spend of quality function in 2014
• Quality spend inclusions and exclusions for 2014
• Actual and desired percentage of resources allocated to these cost of quality categories (appraisal, prevention, etc.)
• Categories used when reporting cost of quality
• Role (lead, support, none) of these key functions in cost of quality budgeting and ownership
• Impact of these factors on increasing the cost of quality

• Quality Spend Mix: Benchmarked companies have a critical improvement area for allocating higher percent of their quality budget to prevention and this change may decrease budget allocated to appraisal activities and external failures.
  
• Quality Reporting and Ownership: It’s important for companies to align quality ownership with quality budget management. As the functions that have the ownership of quality activities obtain more financial resources and responsibilities, budget allocation to several activities will be more effective.
  

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.