Section 11-37-71 - Quality control review and disposition decisions(a) A hemp processor shall establish and follow written standard operating procedures and assign specific staff persons as quality control personnel to fulfill the requirements of this section.(b) Quality control personnel shall conduct a review and make a disposition decision if:(1) A contaminant limit established in section 11-37-23 is exceeded;(2) Production of a batch deviates from established standard operating procedures, including when any step is not completed;(3) There is any unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of a component, hemp product, or packaging, or could lead to the use of an incorrect label;(4) Calibration of an instrument or control suggests a problem that may have resulted in a failure to ensure the quality of a batch of a hemp product; or(5) A hemp product is returned.(c) The quality control review shall include examination of the following, as applicable: (1) Batch production records;(2) Certificates of analysis or other testing records for ingredients;(3) Testing records for finished product;(4) Label and packaging integrity;(5) Expiration date or use by date; and(6) Any other examinations necessary to determine whether quality standards are met.(d) When there is a deviation or unanticipated occurrence during the production and in-process control system that results in or could lead to adulteration of a component, hemp product, or packaging, or could lead to the use of an incorrect label, quality control personnel shall reject the component, hemp product, packaging, or label unless quality control personnel approve a treatment, an in process adjustment, or reprocessing to correct the applicable deviation or occurrence.(e) When a contaminant limit established in section 11-37-23(b) is exceeded during testing required by section 11-37-23(a), quality control personnel shall reject the hemp product.(f) The person who conducts the review and makes the disposition decision shall, at the time of performance, document that review and disposition decision in accordance with section 11-37-75.[Eff 8/9/21; comp 2/24/2022] (Auth: HRS §§ 328G-4, 328G-5) (Imp: HRS §§ 328G-4, 328G-5)