Developing Superior Global Quality Control Operations: Structure, Investment and Service Levels

The Quality Control function within pharmaceutical and medical device companies is responsible for meeting the defined quality standards for drugs and devices at every stage of the product life cycle, from R&D and product development through manufacturing, sale, and post-market support.

As a result, Quality Control leadership faces a balancing act between managing resources, ensuring product quality and compliance, and delivering value to patients and healthcare providers.

Best Practices, LLC conducted this benchmarking research to probe how leading pharmaceutical and medical device companies are improving the effectiveness of their Global Quality Control functions to support their service and product portfolio. This study also benchmarks the staffing levels, budget levels, processes, development and designs, and service levels of Global Quality Control functions.

KEY TOPICS

• Quality Control Staffing & Investment
• Quality Control Structure
• Quality Control Process
• Quality Control Development & Design
• Quality Control Service Levels

• Please estimate the total number of FTEs that work in different parts of your company's Quality Control functional area
• What forces or issues have been driving the percentage changes in your company's functional staffing and spending during the past three years?
• How is your Quality function structured in your company?
• Which approaches do you use to ensure the Quality attributes of your product?
• What role does your Quality function play in funding and managing the listed activities?
• What percentage of total Quality function budget do you allocate to the listed critical Quality channels?
• Which methods do you use in your development and design control process?
• To what extent are the listed post-market data incorporated into new product development at your company?
• Approximately how many open CAPAs and NCEs are you currently processing?
• How many potential field evaluations and actions did your Quality organization experience in 2019?
• How many change requests or engineering change orders does the Quality organization review and assess per year in your company?

• Quality Control Process: Process controls and risk management tactics are the most often-used approaches to ensure quality control.
  

Best Practices, LLC engaged 24 leaders from 22 life sciences and medical device companies in this research through a benchmarking survey. More than 80% of the benchmark class serves at the director level and above.

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