How To Write the Perfect Problem Statement

structured deviation investigation May 28, 2024

 If you work in Biopharmaceutical Manufacturing or Quality, one of the best things you can do to drive reliability in GMP Manufacturing is learn how to craft a strong problem statement.  In this video, we will show you how to do that.  Creating a strong problem statement is pivotal in problem-solving. A well-defined problem statement sets the stage for effective GMP deviation investigation and problem solving.

Video Summary:

  • This video will teach you how to create a clear and effective problem statement.
  • A clear problem statement helps in shift exchanges, GMP production issue escalation, and is a fundamental quality system input.
  • The video provides examples of poor problem statement techniques (narrative and diluted problem statements) which can lead to incorrect conclusions and solutions.
  • A good problem statement combines three frameworks:  object defect, expected state / actual state and the 5Ws (Who, What, When, Where, and Why).
  • Crafting problem statements using this formula promotes faster and efficient problem-solving along with improved communication within the organization.
  • In GMP manufacturing, where compliance and patient safety are paramount, a vague problem statement can lead to misdirected efforts and prolonged issues. A clear, concise problem statement ensures that all team members understand the issue at hand and enables focused and efficient investigations.



Key Quotes on Problem Solving and Problem Statements:

  • "Your ability to solve problems can make or break your GMP manufacturing system...."
  • "The fundamental idea in LEAN manufacturing and structured problem solving is problem solving..."
  • "If you stick with this solution and you develop those three things, you're going to become very very good at writing problem statements.   That is going to make you a more effective communicator and it's going to speed up the process of problem-solving in your organization..."