[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.250]

[Page 151]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                    Subpart O--Statistical Techniques
 
Sec. 820.250  Statistical techniques.


    (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.