The Investigative Process

by | Apr 10, 2023 | Inspections, Product Development, Requirements, Standards

When issues occur that have the potential to impact product quality, Quality Assurance Reports (QAR) are generated to determine what happened, why it happened, and how to prevent it from happening again. An investigation is launched to determine this and what the potential impacts are.

The DMAIC Method is used for this because it is a process used to improve manufacturing processes in a way which utilizes the Six sigma initiative. It can be implemented to determine a quality improvement process or as general process improvements[1] DMAIC stands for Define, Measure, Analyze, Improve, and Control which are described below:

  • Define: In this step, all steps of the problem are defined. Steps in this phase include the problem statement, scope of the impact, where the potential deviation occurred etc.
  • Measure: In this phase, process performance is measured. To facilitate this, process maps are generated, and data is gathered.
  • Analyze: Here, the process is analyzed to determine root causes of deviations or defects. This step potentially includes a Root Cause Analysis (RCA), or a Failure Mode and Effect Analysis (FMEA). Common tools used to successfully drive to root causes during the RCA or Method 1 (M1) process include the 6M or Fishbone analysis and 5 Why’s, among others.
  • Improve: In this step, process improvements are developed, and root causes are eliminated. Design of Experiments (DOE) are done to solve problems where many factors can contribute to an outcome.
  • Control: this step serves to demonstrate control over the improved process. Examples of tools used in this step are Statistical Process Control (SPC) and 5S.

If you need support for implementing successful investigations and using the DMAIC method to drive to root causes and assign preventative actions to ensure product quality, the experts at EMMA International can help! Call us at 248-987-4497 or email us at to learn more.


Jacob Wright

Jacob Wright

Jacob Wright is a Quality Engineer at EMMA International with expertise in regulatory compliance, process validation, and quality management systems. He received his Bachelor of Science and Master's degrees in Biological/Biosystems Engineering from Michigan State University, where he developed a deep understanding of living organisms and engineering systems. Jacob's strong commitment to quality, attention to detail, and risk mitigation skills make him an effective advocate for regulatory compliance and product safety.

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