Haw. Code R. § 11-37-71 - Quality control review and disposition decisions
(a) A hemp processor shall establish and
follow written standard operating procedures and assign specific staff persons
as quality control personnel to fulfill the requirements of this
section.
(b) Quality control
personnel shall conduct a review and make a disposition decision if:
(1) A contaminant limit established in
section 11-37-23 is exceeded;
(2) Production of a batch deviates from
established standard operating procedures, including when any step is not
completed;
(3) There is any
unanticipated occurrence during the processing or manufacturing operations that
adulterates or may lead to adulteration of a component, crude extract,
manufactured hemp product, or packaging, or could lead to the use of an
incorrect label;
(4) Calibration of
an instrument or control suggests a problem that may have resulted in a failure
to ensure the quality of a batch of crude extract or manufactured hemp product;
or
(5) A manufactured hemp product
is returned.
(c) The
quality control review shall include examination of the following, as
applicable:
(1) Batch production
records;
(2) Certificates of
analysis or other testing records for ingredients;
(3) Testing records for finished
product;
(4) Label and packaging
integrity;
(5) Expiration date or
use by date; and
(6) Any other
examinations necessary to determine whether quality standards are
met.
(d) When there is a
deviation or unanticipated occurrence during the production and in-process
control system that results in or could lead to adulteration of a component,
crude extract, or manufactured hemp product, or packaging, or could lead to the
use of an incorrect label, quality control personnel shall reject the
component, crude extract, manufactured hemp product, packaging, or label unless
quality control personnel approve a treatment, an in-process adjustment, or
reprocessing to correct the applicable deviation or occurrence.
(e) When a contaminant limit established in
section 11-37-23 (b) or
(d) is exceeded during testing required by
section 11-37-23(a) or
(c), quality control personnel shall reject
the crude extract or manufactured hemp product.
(f) The person who conducts the review and
makes the disposition decision shall, at the time of performance, document that
review and disposition decision in accordance with section
11-37-75.
Notes
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