42.39.602    TESTING LABORATORY GENERAL REQUIREMENTS

(1) A testing laboratory must employ a full-time scientific director that meets the minimum requirements described in 16-12-206, MCA.

(2) The scientific director must ensure that:

(a) the testing laboratory achieves and maintains ISO/IEC 17025:2017 accreditation for all testing methods/analytes required in ARM 37.107.316;

(b) the testing laboratory's processes and practices are compliant with ISO/IEC 17025:2017 standards;

(c) the testing laboratory maintains quality practices in accordance with their quality manual;

(d) testing personnel have been appropriately trained and demonstrate competency prior to providing testing services;

(e) policies and procedures are in place for monitoring personnel competence;

(f) approved standard operating procedures are in place, have been reviewed, and are followed by all testing personnel;

(g) appropriate test methods are in place;

(h) test method validations have been performed initially and upon test method changes to determine the minimum following requirements as appropriate;

(i) accuracy;

(ii) precision;

(iii) linearity and working range;

(iv) coefficient of determination (r²) for calibration curves;

(v) LOD;

(vi) LOQ;

(vii) MDL; and

(viii) reproducibility.

(i) acceptable analytical test performance is established and maintained for each test system;

(j) quality assurance and quality control programs are established and maintained;

(k) corrective and preventative actions are taken and documented when significant deviations from the testing laboratory's established performance characteristics are identified and test results are reported only when test systems are functioning properly;

(l) the testing laboratory successfully participates in an approved proficiency testing (PT) program(s), as described in this subchapter, for all methods/analytes required in ARM 37.107.316;

(m) the physical and environmental conditions of the testing laboratory are adequate and appropriate for the testing performed; and

(n) the environment for employees is safe from physical, chemical, and biological hazards, and safety and biohazard requirements are met.

(3) A scientific director must be physically present at the testing laboratory for the majority of time that testing is performed in order to adequately carry out his/her responsibilities.

(4) A testing laboratory must be able to perform at least 75% of the quality assurance testing requirements defined in ARM 37.107.316.

(5) A testing laboratory can only refer quality assurance testing to another licensed testing laboratory in Montana which has met the requirements of this subchapter, and the referred testing laboratory must be identified in all testing reports, the certificates of analysis, and the seed-to-sale tracking system.

(6) A testing laboratory must obtain written permission from the licensee prior to sending the laboratory test sample to another testing laboratory in Montana.

(7) A testing laboratory must document certification of all testing performed and corresponding results in a certificate of analysis.

(8) A testing laboratory must maintain for at least three years testing data and reports, including quality control data, standard curves, raw instrument data, calculations, spreadsheets, certificates of analysis, licensee reports, etc.

(9) Records/data may be kept in either paper or electronic form on the premises and must be readily available for quality assurance and inspection purposes.

(10) A testing laboratory must establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergency at all premises.

History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22; TRANS, from ARM 37.107.302, 2023 MAR p. 570, Eff. 7/2/23.