Why divide by accepted units instead of units inspected?

Because only accepted units are sold. Inspection spent on units later scrapped is still paid, so spreading the lot's cost over released units gives the appraisal cost each shipped device must recover.

What should the burdened inspection rate include?

Inspector pay and benefits, the quality department's overhead share, and the hourly cost of the gauges, CMM or vision system used. Cost of quality practice counts inspection setup and test equipment as appraisal costs.

How do I cost a lot that fails and gets sorted 100%?

Rerun with the full lot as the sample size and the units accepted after sorting. The extra over a normal lot is excess inspection, which Juran counts as cost of poor quality.

Where do scrap and rework costs go?

Not here. Inspection is an appraisal cost, spent finding defects; scrap, rework and complaints are failure costs. Track them separately so a rise in one is not hidden in the other.

MedTech Manufacturing calculator

Medical Device Inspection Cost per Unit Calculator

Price the inspection each released device carries before you set a standard cost or quote a part number. Enter the sample size, points per unit, time per point, setup and records time, burdened rate and accepted units.

What this calculator does

Inspection cost each accepted device carries, built from sample size, points, time per point, setup and a burdened inspection rate.

Formula used

Measurement hours per lot = sample size × inspection points per unit × time per point (s) ÷ 3,600
Inspection hours per lot = measurement hours + setup and records per lot (min) ÷ 60
Each cost per lot = its hours × burdened inspection rate
Inspection cost per accepted unit = inspection cost per lot ÷ accepted units per lot
Setup and records share = setup and records hours ÷ inspection hours per lot

Inputs explained

Sample Size: Units your sampling plan pulls per lot; every unit for 100% inspection.
Inspection Points per Unit: Characteristics checked on each sampled unit, from the inspection instruction.
Time per Point: Handle, measure and record one point, from a time study.
Setup and Records per Lot: Gauge verification, fixture setup and inspection record entry, timed per lot.
Burdened Inspection Rate: Inspector pay, benefits and overhead per hour, plus gauge or CMM cost.
Accepted Units per Lot: Units released from the lot, net of rejects, per the batch record.

How to use the result

Best suited to inspection line in a device standard cost, quoting inspection for a new part number, comparing manual gauging with a vision station.
Destructive test units, outside lab fees and first article inspections are not included. A rejected lot sorted 100% costs far more; price it with the full lot as the sample.

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

Why divide by accepted units instead of units inspected? Because only accepted units are sold. Inspection spent on units later scrapped is still paid, so spreading the lot's cost over released units gives the appraisal cost each shipped device must recover.
What should the burdened inspection rate include? Inspector pay and benefits, the quality department's overhead share, and the hourly cost of the gauges, CMM or vision system used. Cost of quality practice counts inspection setup and test equipment as appraisal costs.
How do I cost a lot that fails and gets sorted 100%? Rerun with the full lot as the sample size and the units accepted after sorting. The extra over a normal lot is excess inspection, which Juran counts as cost of poor quality.
Where do scrap and rework costs go? Not here. Inspection is an appraisal cost, spent finding defects; scrap, rework and complaints are failure costs. Track them separately so a rise in one is not hidden in the other.

Last reviewed 2026-10-01.