N.Y. Comp. Codes R. & Regs. tit. 9 § 130.13

Current through Register Vol. 46, No. 43, October 23, 2024

Section 130.13 - Cannabis Quality Assurance Officer Qualifications

(a) A cannabis laboratory shall appoint a quality assurance officer, who shall exercise oversight of a cannabis laboratory's quality system during normal business hours. The individual so appointed shall have documented training, and/or experience in quality assurance and quality control procedures; be knowledgeable in the required quality system; possess a general knowledge of analytical methods for which they perform data review; and have a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, and two (2) or more years of experience in implementing a laboratory quality system.

(b) The quality assurance officer shall, at a minimum:

(1) serve as the focal point for a cannabis laboratory's quality assurance and quality control, and be responsible for monitoring and/or review of quality control data;

(2) evaluate data objectively and perform independent managerial reviews without outside influence;

(3) arrange for or conduct annual internal audits of a cannabis laboratory's entire quality system and testing operation; and

(4) notify cannabis laboratory management of any deficiencies in the quality system as part of an internal audit and monitor required corrective actions.

(c) The quality assurance officer shall have direct access to the highest level of management at which decisions are made on cannabis laboratory policy or resources, as well as to a technical director.

(d) The quality assurance officer shall fulfill their functions independently from cannabis laboratory operations for which they maintain quality assurance oversight.

(e) For cannabis laboratories with limited staffing, the quality assurance officer may also be a lead technical director or technical director; and an individual meeting the requirements of this section may not be the quality assurance officer of more than one cannabis laboratory without written authorization from the Office.

(f) An individual who meets the experience requirements but not the educational and/or credential requirements of this Part, and is functioning in a quality assurance officer's capacity as subject to this section, and is functioning in a quality assurance officer's capacity on the date a cannabis laboratory becomes subject to these regulations, shall qualify as quality assurance officer of that cannabis laboratory, or any other cannabis laboratory permitted by the Office and performing similar testing, provided such individual has been quality assurance officer in that cannabis laboratory for the previous twelve (12) consecutive months. An individual who is admitted as a quality assurance officer under these conditions, and leaves a cannabis laboratory, will be eligible for hire as a quality assurance officer in another permitted cannabis laboratory.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.13

Adopted New York State Register March 22, 2023/Volume XLV, Issue 12, eff. 3/22/2023