S.D. Admin. R. 44:90:04:02

Current through Register Vol. 51, page 67, December 16, 2024

Section 44:90:04:02 - Corrective and preventive action - Written procedures

An establishment shall maintain and follow written procedures for implementing corrective action and preventive action, including:

(1) Analysis of processes, work operations, reports, records, service records, complaints, returned product, and other sources of data to identify existing and potential root causes of nonconformance or other quality problems;

(2) Identifying any actions needed to correct and prevent recurrence of nonconformance and other quality problems;

(3) Verifying the corrective action or preventive action to ensure that such action is effective and does not adversely affect finished products or processes;

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

(5) Ensuring the information related to quality problems or nonconformance is disseminated to those directly responsible for assuring the quality of products or the prevention of such problems;

(6) Submitting relevant information on identified quality problems and corrective action and preventive action documentation and confirming the result of the evaluation for management review; and

(7) Ensuring that cannabis or cannabis products that are nonusable or otherwise do not meet safety standards established by this article are quickly identified and destroyed or remediated to prevent harm to patients.

S.D. Admin. R. 44:90:04:02

48 SDR 040, effective 10/5/2021

General Authority: SDCL 34-20G-72(5)(a).

Law Implemented: SDCL 34-20G-63, 34-20G-71, 34-20G-72(5).