Section 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.Wash. Admin. Code § 16-310-100
Adopted by WSR 24-13-102, Filed 6/18/2024, effective 7/1/2024