Wash. Admin. Code § 16-310-100 - Data and record traceability
(1) During audits and when necessary, the
department will ask the lab to demonstrate data and record traceability with
documentation. To demonstrate this, a cannabis laboratory must:
(a) Be able to recreate sample results by
means of records in entirety, starting at receipt of the samples by the
laboratory and ending at the final report or certificate of analysis, known as
a data pack;
(b) Document
validation of any chemical, reagent, and/or media used by an analytical
method;
(c) Document storage of
samples as required by the specific analytical method and
regulations;
(d) Document that all
temperature-based equipment such as a refrigerator, oven, or incubator is
within control at the time of testing. When electronic recordkeeping equipment
is used, these records must be monitored by lab personnel to verify that
temperatures meet relevant method and regulatory requirements;
(e) Keep a log for all instruments, including
documentation of installation, setup, maintenance, and removal from service;
and
(f) Document preparation and
quality control (QC) of chemicals, reagents, and media used in support of the
analyses.
(2) When
records are handwritten, they must be in indelible ink and comply with the
relevant method requirements and include the date, technician's initials, and
temperature when relevant. Any changes to handwritten records should be single
line crossed out, initialed, and dated.
(3) Unmonitored use of continuous
data-loggers is not an acceptable substitute when methods and regulations
require temperature checks. Use of electronic recordkeeping equipment is
allowed when:
(a) The equipment can
demonstrate the accuracy and precision required by the applicable method and
regulations;
(b) It includes the
date and time the record was captured, using a fully traceable and secure
format; and
(c) It is reviewed for
failure each day instrument or equipment is used.
(4)
(a)
Certificates of analysis must be consistent with laboratory data.
(b) Reference labs must be named on the
certificate of analysis when used.
Notes
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