Elaine Guan answers:

A: Generally speaking, qualifying activities for R&D are those that are innovative in nature and further develop or improve a product or process. Qualifying activities for manufacturing are no different! Below are some examples of qualifying and non-qualifying activities that might apply to manufacturing products or processes.

 Manufacturing – Qualifying Activities

  • Designing or engineering new product designs
  • Modeling, building, or testing prototypes
  • Performing manufacturing test runs on new products
  • Modifying manufacturing processes to improve quality, speed, yield, or efficiency, or to reduce cost or waste
  • Quality testing new products prior to them becoming commercially available
  • Serving as a liaison between customers and the development team to identify desired design improvements

 Manufacturing – Non-Qualifying Activities

  • Manufacturing of existing products
  • Repairs and maintenance
  • Customer technical support or helpdesk
  • Post-release testing, analysis, or quality testing
  • Time spent working outside the US

Other non-R&D related matters (e.g., HR, management, budgeting, marketing, manufacturing, customer relations, training, 2nd level and above management, etc.)


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