Does FDA require a record for every lot?

Yes: section 820.35 requires the unique device identifier to be recorded for each device or batch, on top of the ISO 13485 traceability clauses. Enter one record per lot, or per device if you serialize.

What counts as a record correction?

Any lot whose record goes back after review for a missing, wrong or illegible entry. Count lots, not individual errors, and time the whole loop: finding the right value, correcting and initialing it, and the second review.

Why does lot traceability matter in a recall?

Because a correction or removal report to FDA must list the lot or serial numbers involved, under section 806.10. Complete lot records let you scope a recall to the affected lots instead of every lot built.

When does an MES or eQMS pay for itself?

When the record and correction time it removes is worth more than its added system cost per period. Rerun it with your expected record minutes and corrections at the new system cost.

MedTech Manufacturing calculator

Lot Traceability Cost Calculator

Find what lot traceability records cost per period and per lot before you budget quality staff or compare paper records with an MES. You need lots, record and correction minutes, lots corrected, a burdened rate and system cost.

What this calculator does

Period and per-lot cost of building, reviewing and correcting lot traceability records, including your traceability system.

Formula used

Record and review cost = production lots × record and review minutes ÷ 60 × burdened hourly rate
Record correction cost = lots with record corrections × correction minutes ÷ 60 × burdened hourly rate
Lot traceability cost = record and review cost + record correction cost + traceability system cost
Cost per lot = lot traceability cost ÷ production lots
Records right first time = (production lots − lots with record corrections) ÷ production lots × 100

Inputs explained

Production Lots per Period: Lots whose traceability records were completed and reviewed this period.
Record and Review Minutes per Lot: Entering component lots, equipment and sign-offs, plus QA review, per lot.
Lots With Record Corrections: Lots whose record review found missing or wrong entries, from review logs.
Correction Minutes per Lot: Time to trace, correct, initial and re-review one lot's record.
Burdened Hourly Rate: Blended wage, benefits and overhead of operators and QA reviewers.
Traceability System Cost per Period: ERP, MES or eQMS license, hosting and validation share for the period.

How to use the result

Best suited to budgeting quality staff time for record review, comparing paper records with an MES, pricing traceability into a contract manufacturing quote.
Excludes trace exercises, recall scoping and nonconformance investigations that record errors trigger.

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

Does FDA require a record for every lot? Yes: section 820.35 requires the unique device identifier to be recorded for each device or batch, on top of the ISO 13485 traceability clauses. Enter one record per lot, or per device if you serialize.
What counts as a record correction? Any lot whose record goes back after review for a missing, wrong or illegible entry. Count lots, not individual errors, and time the whole loop: finding the right value, correcting and initialing it, and the second review.
Why does lot traceability matter in a recall? Because a correction or removal report to FDA must list the lot or serial numbers involved, under section 806.10. Complete lot records let you scope a recall to the affected lots instead of every lot built.
When does an MES or eQMS pay for itself? When the record and correction time it removes is worth more than its added system cost per period. Rerun it with your expected record minutes and corrections at the new system cost.

Last reviewed 2026-10-01.