Section 22-B10716. CORRECTIVE AND PREVENTIVE ACTION

 

10716.1Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
 

(a) 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;

 

(b) Investigating the cause of nonconformities relating to product, processes, and the quality system;

 

(c) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

 

(d) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

 

(e) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

 

(f) 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

 

(g) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

 

10716.2All activities required under this section, and their results, shall be documented.  

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).