Rule 42.39.604 - TESTING LABORATORY QUALITY ASSURANCE PROGRAM(1) The testing laboratory shall develop and implement a quality assurance program to assure the reliability and validity of the analytical data produced by the testing laboratory. The quality assurance program shall, at a minimum, include a written quality assurance plan or manual that addresses the following: (a) quality control procedures;(b) testing laboratory organization and employee training and responsibilities, including good laboratory practice (GLP);(c) quality assurance objectives for measurement data;(d) traceability of data and analytical results;(e) instrument maintenance, calibration procedures, and frequency;(f) performance and system audits;(g) corrective and preventative action procedures;(h) steps to change processes when necessary; (i) record retention and document control;(j) laboratory test sample retention and disposal;(k) test procedure standardization; and(2) The scientific director shall annually review, amend if necessary, and approve the quality assurance program and plan both when they are created and when there is a change in methods, laboratory equipment, or the scientific director.(3) All testing laboratory personnel shall review the quality assurance plan upon revision or at least annually.Mont. Admin. r. 42.39.604
NEW, 2019 MAR p. 1868, Eff. 10/19/2019; AMD, 2022 MAR p. 58, Eff. 1/15/2022; TRANS, from 37.107.307, 2023 MAR p. 570, Eff. 7/2/2023AUTH: 16-12-202, 16-12-209, MCA; IMP: 16-12-202, 16-12-209, MCA