[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.100]

[Page 147]
 
                        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 J--Corrective and Preventive Action
 
Sec. 820.100  Corrective and preventive action.


    (a) Each manufacturer shall establish and maintain procedures for 
implementing corrective and preventive action. The procedures shall 
include requirements for:
    (1) Analyzing processes, work operations, concessions, quality audit 
reports, quality records, service records, complaints, returned product, 
and other sources of quality data to identify existing and potential 
causes of nonconforming product, or other quality problems. Appropriate 
statistical methodology shall be employed where necessary to detect 
recurring quality problems;
    (2) Investigating the cause of nonconformities relating to product, 
processes, and the quality system;
    (3) Identifying the action(s) needed to correct and prevent 
recurrence of nonconforming product and other quality problems;
    (4) Verifying or validating the corrective and preventive action to 
ensure that such action is effective and does not adversely affect the 
finished device;
    (5) Implementing and recording changes in methods and procedures 
needed to correct and prevent identified quality problems;
    (6) Ensuring that information related to quality problems or 
nonconforming product is disseminated to those directly responsible for 
assuring the quality of such product or the prevention of such problems; 
and
    (7) Submitting relevant information on identified quality problems, 
as well as corrective and preventive actions, for management review.
    (b) All activities required under this section, and their results, 
shall be documented.