Mich. Admin. Code R. 420.305b

Current through Vol. 24-09, June 1, 2024
Section R. 420.305b - Quality assurance and quality control

Rule 5b.

(1) A laboratory must have a procedure for monitoring the validity of results.
(2) This monitoring must occur on an ongoing basis and be reviewed by the laboratory manager. The monitoring must include all of the following:
(a) Use of reference materials or quality control materials.
(b) A functional check or checks of measuring and testing equipment.
(c) Use of working standards and verification with control charts, where applicable.
(d) Intermediate checks on measuring equipment.
(e) Review of reported results.
(f) Intra-laboratory comparisons, which involve proficiency testing.
(3) A laboratory shall adhere to all required quality control procedures specified in the reference method or methods to ensure that routinely generated analytical data is scientifically valid and defensible and is of known and acceptable precision and accuracy.
(4) A laboratory shall have a written quality assurance manual that includes, but is not limited to, all of the following items:
(a) Laboratory organization and responsibilities.
(c) Field sampling procedures.
(d) Instrument and equipment preventative maintenance and calibration procedures.
(e) Data reduction, validation, reporting, and verification.
(f) Identification of laboratory errors, customer complaints, and corrective actions.
(5) A laboratory shall prepare a written description of its quality control activities, included as part of a quality control manual. All of the following items must be addressed in the quality control manual:
(a) Daily, weekly, monthly, and annual requirements.
(b) An analytical testing batch.
(c) All analytical testing runs must be bracketed with quality controls.
(6) Method specific quality control acceptance criteria, which must be followed.
(7) A laboratory shall have standard operating procedures for all sampling and testing performed.
(8) All standard operating procedures for the required safety tests in R 420.305 and for sampling and testing of marihuana and marihuana products shall conform to ISO/IEC 17025:2017 standards, Good Laboratory Practice Standards 40 CFR 160, and shall be approved by the agency prior to the performance of any safety tests.
(9) A laboratory shall maintain a quality control and quality assurance program that conforms to Good Laboratory Practice Standards 40 CFR 160 and ISO/IEC 17025:2017 standards and meets the requirements established by the agency.

Mich. Admin. Code R. 420.305b

2022 MR 5, Eff. 3/7/2022