Each potential failure mode is scored for severity, likelihood of occurrence and detectability, and the scores are combined into a risk priority number or a similar ranking. ICH Q9 lists FMEA among the recognized risk management tools for pharmaceutical quality, and it is widely used for medical devices and in risk assessments for validation. The output drives actions: controls that reduce the risk, and checks that detect a failure earlier.

Why it matters for labeling

Applied to labeling, an FMEA shows where the process is most exposed: late changes, version mix-ups, translations, variable data printing, and hand-offs to printers. The detectability score matters most. Errors that are hard to see by eye, such as a changed digit or a barcode that decodes to the wrong value, score poorly for detection, which is an argument for automated checking at those steps. FMEA is also used to decide how much validation effort a computerized system needs.

Common mistakes

  • Scoring from opinion with no data behind it
  • Treating the risk priority number as more precise than it is
  • Doing it once and filing it
  • No actions linked to the high-risk failure modes
  • Counting a detection control that isn't reliably used in practice

Sources

  • ICH: Q9(R1), Quality Risk Management