Mich. Admin. Code 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.
Notes
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