FDA Intel

21 CFR 820.250: Statistical techniques

Required manufacturers, where appropriate, to maintain procedures identifying valid statistical techniques for process capability and product characteristics, and to use written, statistically justified sampling plans that were reviewed on change, with documentation.

Part 820, Quality System Regulation · Subpart O, Statistical Techniques

Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.

How FDA words it

The opening lines investigators use most when they cite 820.250, from the 483s we hold.

Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.Most used
Sampling plans are not based on valid statistical rationale.820.250(b)
Procedures to ensure sampling methods are adequate for their intended use have not been adequately established.820.250(b)

Cited over time

483s citing 820.250, by year

Most citations in 2024. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2024.

Recent 483s citing 820.250

See all 483s citing 820.250

The regulation text

§ 820.250 Statistical techniques. As published before it was replaced.

(a)Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.

(b)Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.

Questions

What does 21 CFR 820.250 require?

Required manufacturers, where appropriate, to maintain procedures identifying valid statistical techniques for process capability and product characteristics, and to use written, statistically justified sampling plans that were reviewed on change, with documentation.

How do FDA investigators word a 820.250 observation?

The most common opening is: “Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.”

Which sections are cited alongside 820.250?

In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.30 (Design controls), 820.75 (Process validation), 820.198 (Complaint files).