MedTech Manufacturing worked example

Nonconformance Cost with affected units of 38 devices: a worked example in medtech manufacturing

Suppose affected units falls to 38 devices. This page works the full calculation at that level so you can see exactly which result moves and by how much. Estimate total cost of a nonconformance event including affected units, rework/material cost, investigation, and production disruption.

The inputs for this scenario

  • Affected units: 38 devices (the input this scenario stresses; the baseline uses 75)
  • Material and rework cost per unit: 12 $ / device (held at the documented default)
  • Fixed investigation cost: 3,500 $ (held at the documented default)
  • Production disruption cost: 1,800 $ (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Total nonconformance cost = affected units × rework cost per unit + fixed investigation cost + production disruption cost.
  • Total nonconformance event cost works out to 5,756 $ at these inputs, and this is the headline figure for the scenario.
  • Cost per affected device works out to 151 $ / piece at these inputs.
  • Total rework/material cost works out to 456 $ at these inputs.
  • Investigation plus disruption cost works out to 5,300 $ at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where affected units sits at 75 devices and the headline result is 6,200 $, this scenario comes in 7.16% below the baseline at 5,756 $.
  • It sums per-unit material and rework cost across affected devices plus fixed investigation and production disruption costs, then divides by affected units for a per-device figure. When the numbers land here, the stressed input is the lever to work; the walkthrough above shows exactly how much each output recovers as it climbs back toward the baseline.

Results at a glance

  • Total nonconformance event cost: 5,756 $ (headline result)
  • Cost per affected device: 151 $ / piece
  • Total rework/material cost: 456 $
  • Investigation plus disruption cost: 5,300 $

Run it with your numbers

  • To rerun this with your own numbers, open the live Nonconformance Cost calculator, set affected units to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.