What counts as an affected device?

Every device held under the report and then sorted, reworked or retested. Devices sorted and found good still count, because the hold and sort cost money; scrapped devices are priced separately.

Where does rework cost stop and a cause fix begin?

Rework, sorting and retest cost money now; removing the cause is a separate budget item. Price what this event consumed here, and treat the cause fix as its own decision.

What drives the investigation hours I log?

The extent of the nonconformity and its risk decide the depth. Log the hours actually spent on containment, data review and disposition, and let the trend show whether more depth is warranted.

What idle line cost per hour should I use?

Use the crew pay and fixed line overhead that keep running while the line waits, from your standard cost rates. Leave out materials not consumed and lost sales, which this page does not price.

MedTech Manufacturing calculator

Nonconformance Event Cost Calculator

Price one nonconformance report for material review, a cost Pareto or a corrective action case. You need affected devices, rework cost per device, investigation hours, a burdened rate, and any line stoppage.

What this calculator does

Cost of one nonconformance from hold to closure: rework of affected devices, investigation hours and idle line time.

Formula used

Rework cost = affected devices × rework cost per affected device
Investigation cost = investigation hours × burdened hourly rate
Line stoppage cost = line stoppage hours × idle line cost per hour
Total nonconformance cost = rework cost + investigation cost + line stoppage cost
Cost per affected device = total nonconformance cost ÷ affected devices

Inputs explained

Affected Devices: Devices held under the nonconformance report, then sorted or reworked.
Rework Cost per Affected Device: Average rework labor, parts and retest, including devices found good.
Investigation Hours: Containment, root cause, material review and closure records, all staff.
Burdened Hourly Rate: Pay, benefits and overhead per hour of the staff investigating.
Line Stoppage: Hours the line stood idle for containment, from the production log.
Idle Line Cost per Hour: Crew pay and fixed line overhead that continue while the line waits.

How to use the result

Best suited to material review cost summary, nonconformance pareto by cost, corrective action business case.
Devices scrapped under the report are left out; price them as scrap with investigation hours at zero. Field corrections, complaints and the corrective action project itself are separate costs.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

What counts as an affected device? Every device held under the report and then sorted, reworked or retested. Devices sorted and found good still count, because the hold and sort cost money; scrapped devices are priced separately.
Where does rework cost stop and a cause fix begin? Rework, sorting and retest cost money now; removing the cause is a separate budget item. Price what this event consumed here, and treat the cause fix as its own decision.
What drives the investigation hours I log? The extent of the nonconformity and its risk decide the depth. Log the hours actually spent on containment, data review and disposition, and let the trend show whether more depth is warranted.
What idle line cost per hour should I use? Use the crew pay and fixed line overhead that keep running while the line waits, from your standard cost rates. Leave out materials not consumed and lost sales, which this page does not price.

Last reviewed 2026-10-01.