(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.
