<html xmlns="http://www.w3.org/1999/xhtml"><head><meta charset="UTF-8" /><title></title><meta name="Generator" content="PowerTools for Open XML" /><style>span { white-space: pre-wrap; } p.s713ecf4c-71a2-481c-90b8-2abf786c8820P0 { margin-top: 0; margin-bottom: 0; margin-left: 0; margin-right: 0; text-indent: 0.00in; text-align: justify; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; } span.s713ecf4c-71a2-481c-90b8-2abf786c8820C0 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000001 { color: black; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s713ecf4c-71a2-481c-90b8-2abf786c8820000002 { color: black; background: white; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } span.s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000003 { color: #0000FF; background: white; font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } </style></head><body><div><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    </span><a href="https://sdlegislature.gov/Rules?Rule=44:90:04:02"><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">44</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">:</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">90</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">:</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">04</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">:</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000000">02</span></a><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000001">.  Corrective and preventive action -- Written procedures.</span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0"> </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">An establishment shall maintain and follow written procedures for implementing corrective action and preventive action, including:</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820000002"> </span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (1)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">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;</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (2)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">Identifying any actions needed to correct and prevent recurrence of nonconformance and other quality problems;</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (3)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">Verifying the corrective action or preventive action to ensure that such action is effective and does not adversely affect finished products or processes;</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (4)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (5)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">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;</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (6)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">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</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    (7)  </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">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</span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">.</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820000002"> </span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000001">Source:</span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0"> </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">48 SDR 40, effective October 5, 2021.</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000001">General Authority:</span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0"> </span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-20G-72"><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000003">34-20G-72</span></a><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">(5)(a).</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">    </span><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000001">Law Implemented:</span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0"> </span><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">SDCL </span><a href="https://sdlegislature.gov/Statutes?Statute=34-20G-63"><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000003">34-20G-63</span></a><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-20G-71"><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000003">34-20G-71</span></a><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">, </span><a href="https://sdlegislature.gov/Statutes?Statute=34-20G-72"><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0-000003">34-20G-72</span></a><span class="s713ecf4c-71a2-481c-90b8-2abf786c8820C0">(5).</span></p><p dir="ltr" class="s713ecf4c-71a2-481c-90b8-2abf786c8820P0"><span xml:space="preserve" class="s713ecf4c-71a2-481c-90b8-2abf786c8820000002"> </span></p></div></body></html>