Washington Administrative Code › Title 314 - Liquor and Cannabis Board › Chapter 314-55 - Cannabis licenses, application process, requirements, and reporting › Section 314-55-103 - Good laboratory practice checklist

Current through Register Vol. 24-14, July 15, 2024
A third-party testing lab must be certified by the WSLCB or its
				vendor as meeting the WSLCB's accreditation and other requirements prior to
				conducting required quality assurance tests. The following checklist will be
				used by the WSLCB or its vendor to certify third-party testing labs:
ORGANIZATION
Completed by:
Reviewed by:
Document Reference
Y
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NA
Comments
1. The laboratory or the organization of which it is a
						  part of shall be an entity that can be held legally responsible.
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2. The laboratory conducting third-party testing shall
						  have no financial interest in a licensed producer or processor for which
						  testing is being conducted.
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If the laboratory is part of an organization performing
						  activities other than testing, the responsibilities of key personnel in the
						  organization that have an involvement or influence on the testing activities of
						  the laboratory shall be defined in order to identify potential conflicts of
						  interest.
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3. The laboratory shall have policies and procedures to
						  ensure the protection of its client's confidential information and proprietary
						  rights, including procedures for protecting the electronic storage and
						  transmission of results.
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4. In every instance where the lab references
						  certification status they shall clearly indicate which tests they are currently
						  certified for.
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5. The laboratory is responsible for all costs of
						  initial certification and ongoing site assessments.
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6. The laboratory must agree to site assessments every
						  year for the first three years to maintain certification. Beginning year four
						  of certification, on-site assessments will occur every two years to maintain
						  certification.
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7. The laboratory must allow WSLCB staff or their
						  representative to conduct physical visits and check I-502 related laboratory
						  activities at any time.
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8. The laboratory must report all test results directly
						  into WSLCB's traceability system within twenty-four hours of completion. Labs
						  must also record in the traceability system an acknowledgment of the receipt of
						  samples from producers or processors and verify if any unused portion of the
						  sample was destroyed or returned to the customer.
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HUMAN RESOURCES
Completed by:
Reviewed by:
Document Reference
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Comments
9a. Job descriptions for owners and all employees. A
						  written and documented system detailing the qualifications of each member of
						  the staff including any specific training requirements applicable to analytical
						  methods.
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b. Specialized training such as by vendors, classes
						  granting CEUs, etc., shall be documented in each training file.
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10. Qualifications of owners and staff: CVs for staff
						  on file.
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a. Have technical management which has overall
						  responsibility for the technical operations and the provision of the resources
						  needed to ensure the required quality of laboratory operations.
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b. Documentation that the scientific director meets the
						  requirements of WSLCB rules.
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c. Chain of command, personnel organization/flow chart,
						  dated and signed by the laboratory director.
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d. Written documentation of delegation of
						  responsibilities in the absence of the scientific director and management staff
						  (assigned under chapter 314-55 WAC as related to quality assurance
						  testing).
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e. Documentation of employee competency (DOC): Prior to
						  independently analyzing samples, and on an annual, ongoing basis, testing
						  personnel must demonstrate acceptable performance on precision, accuracy,
						  specificity, reportable ranges, blanks, and unknown challenge samples
						  (proficiency samples or internally generated quality controls). Dated and
						  signed by the laboratory director.
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f. The laboratory management shall ensure the
						  competence of all who operate specific equipment, perform tests and/or
						  calibrations, evaluate results, and sign test reports and calibration
						  certificates.
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g. When using staff who are undergoing training,
						  appropriate supervision shall be provided.
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h. Personnel performing specific tasks shall be
						  qualified on the basis of appropriate education, training, experience and/or
						  demonstrated skills, as necessary.
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i. The management shall authorize specific personnel to
						  perform particular types of sampling, test and/or calibration, to issue test
						  reports and calibration certificates, to give opinions and interpretations and
						  to operate particular types of equipment.
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j. The laboratory shall maintain records of the
						  relevant authorization(s), competence, educational and professional
						  qualifications, training, skills and experience of all technical personnel,
						  including contracted personnel.
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k. Successful training (in-house courses are
						  acceptable) in specific methodologies used in the laboratory shall be
						  documented.
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l. Designate a quality manager (however named) who,
						  irrespective of other duties and responsibilities, shall have defined
						  responsibility and authority for ensuring that the quality system is
						  implemented and followed; the quality manager shall have direct access to the
						  highest level of management at which decisions are made on laboratory policy or
						  resources.
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m. The laboratory shall delegate responsibilities for
						  key managerial personnel to be acted upon in cases of absence or
						  unavailability.
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n. The laboratory shall provide adequate supervision of
						  testing staff, including trainees, by persons familiar with methods and
						  procedures, purpose of each test and/or calibration, and with the assessment of
						  the test or calibration results.
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11. Standard operating procedure for the
						  following:
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a. Instructions on regulatory inspection and
						  preparedness.
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b. Instruction on law enforcement interactions.
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c. Information on U.S. federal laws, regulations, and
						  policies relating to individuals employed in these operations, and the
						  implications of these for such employees.
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d. Written and documented system of employee training
						  on hazards (physical and health) of chemicals in the workplace, including
						  prominent location of MSDS or SDS sheets and the use of appropriate PPE.
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e. Written and documented system on the competency of
						  personnel on how to handle chemical spills and appropriate action; spill kit
						  on-site and well-labeled, all personnel know the location and procedure.
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f. Information on how employees can access medical
						  attention for chemical or other exposures, including follow-up examinations
						  without cost or loss of pay.
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g. Biosafety at a minimum covering sterilization and
						  disinfection procedures and sterile technique training.
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STANDARD OPERATING
						  PROCEDURES
Document Reference
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Comments
12. As appropriate, laboratory operations covered by
						  procedures shall include, but not be limited to, the following:
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a. Environmental, safety and health activities;
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b. Sample shipping and receipt;
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c. Laboratory sample chain of custody and material
						  control;
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d. Notebooks/logbooks;
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e. Sample storage;
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f. Sample preparation;
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g. Sample analysis;
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h. Standard preparation and handling;
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i. Postanalysis sample handling;
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j. Control of standards, reagents and water
						  quality;
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k. Cleaning of glassware;
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l. Waste minimization and disposition.
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13. The following information is required for
						  procedures as appropriate to the scope and complexity of the procedures or work
						  requested:
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a. Scope (e.g., parameters measured, range, matrix,
						  expected precision, and accuracy);
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b. Unique terminology used;
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c. Summary of method;
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d. Interferences/limitations;
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e. Approaches to address background corrections;
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f. Apparatus and instrumentation;
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g. Reagents and materials;
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h. Hazards and precautions;
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i. Sample preparation;
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j. Apparatus and instrumentation setup;
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k. Data acquisition system operation;
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l. Calibration and standardization;
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m. Procedural steps;
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n. QC parameters and criteria;
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o. Statistical methods used;
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p. Calculations;
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q. Assignment of uncertainty;
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r. Forms used in the context of the procedure.
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s. Document control with master list identifying the
						  current revision status of documents.
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FACILITIES AND
						  EQUIPMENT
Document Reference
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Comments
14. Allocation of space: Adequate for number of
						  personnel and appropriate separation of work areas.
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15. Arrangement of space.
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a. Allows for appropriate work flow, sampling, lab
						  space separate from office and break areas.
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b. Employee bathroom is separate from any laboratory
						  area.
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16. Adequate eyewash/safety showers/sink.
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17. Procurement controls.
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a. The laboratory shall have procedure(s) for the
						  selection and purchasing of services and supplies it uses that affect the
						  quality of the tests and/or calibrations. Procedures covering reagents and
						  laboratory consumables shall exist for the purchase, receipt, storage, and
						  disposition of expired materials.
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b. The laboratory shall ensure that purchased supplies
						  and reagents and consumable materials that affect the quality of tests and/or
						  calibrations are inspected or otherwise verified as complying with standard
						  specifications or requirements defined in the methods for the tests and/or
						  calibrations concerned.
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i. Reagents and standards shall be inspected, dated and
						  initialed upon receipt, and upon opening.
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ii. Calibration standards and analytical reagents shall
						  have an expiration or reevaluation date assigned.
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iii. Solutions shall be adequately identified to trace
						  back to preparation documentation.
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c. Prospective suppliers shall be evaluated and
						  selected on the basis of specified criteria.
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d. Processes to ensure that approved suppliers continue
						  to provide acceptable items and services shall be established and
						  implemented.
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18. Subcontracting.
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a. The laboratory shall advise the customer of the
						  subcontract arrangement in writing, including the subcontractors' accreditation
						  credentials under chapters 69.50 RCW and 314-55 WAC.
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b. The laboratory shall maintain a register of all
						  subcontractors that it uses for tests and/or calibrations and a record of the
						  evidence of compliance with chapter 314-55 WAC for the work in question.
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c. When there are indications that subcontractors
						  knowingly supplied items or services of substandard quality, this information
						  shall be forwarded to appropriate management for action.
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19. Utilities (items verified upon on-site
						  inspection).
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a. Electrical:
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i. Outlets: Adequate, unobstructed, single-use,
						  multiplug adaptors with surge control;
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ii. Single-use extension cords;
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iii. Ground fault circuit interrupters near wet
						  areas.
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b. Plumbing:
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i. Appropriateness of sink usage: Separate sinks for
						  work/ personal use;
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ii. Adequate drainage from sinks or floor
						  drains;
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iii. Hot and cold running water.
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c. Ventilation:
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i. Areas around solvent use or storage of solvents or
						  waste solvents;
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ii. Vented hood for any microbiological analysis -
						  Class II Type A biosafety cabinet as applicable.
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iii. Fume hood with appropriate ventilation.
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d. Vacuum: Appropriate utilities/traps for prevention
						  of contamination (as applicable).
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e. Shut-off controls: Located outside of the
						  laboratory.
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20. Waste disposal: Appropriate for the type of waste
						  and compliant with WAC
						  314-55-097
						  Cannabis waste disposal-Liquids and solids.
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21. Equipment. Equipment and/or systems requiring
						  periodic maintenance shall be identified and records of major equipment shall
						  include:
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a. Name;
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b. Serial number or unique identification from name
						  plate;
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c. Date received and placed in service;
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d. Current location;
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e. Condition at receipt;
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f. Manufacturer's instructions;
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g. Date of calibration or date of next
						  calibration;
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h. Maintenance;
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i. History of malfunction.
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22. Maintenance.
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a. Documented evidence of routine preventive
						  maintenance and calibration of equipment including, but not limited to:
						  Thermometer, pipette, analytical balances, and additional analytical
						  equipment.
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i. Calibration programs shall be established for key
						  quantities or values of the instruments where these properties have a
						  significant effect on the results.
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ii. Before being placed into service, equipment,
						  including equipment used for sampling, shall be calibrated or checked to
						  establish that it meets the laboratory's specification requirements and
						  complies with the relevant standard specifications.
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iii. Equipment that has been subjected to overloading
						  or mishandling, gives suspect results, or has been shown to be defective or
						  outside of specified limits, shall be taken out of service. Such equipment
						  shall be isolated to prevent its use or clearly labeled or marked as being
						  out-of-service until it has been repaired and shown by calibration or test to
						  perform correctly.
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b. Documentation of a maintenance schedule and reviewed
						  by the laboratory director.
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i. Calibration procedures shall specify frequency of
						  calibration checks.
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ii. Instruments that are routinely calibrated shall be
						  verified daily or prior to analyzing samples (as applicable).
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iii. Acceptance criteria shall be determined,
						  documented and used.
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iv. When possible, any external calibration service
						  (metrological laboratory) used shall be a calibration laboratory accredited to
						  ISO/IEC 17025:2005 by a recognized accreditation body.
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v. Laboratories shall demonstrate, when possible, that
						  calibrations of critical equipment and hence the measurement results generated
						  by that equipment, relevant to their scope of accreditation, are traceable to
						  the SI through an unbroken chain of calibrations.
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vi. External calibration services shall, wherever
						  possible, be obtained from providers accredited to one of the following:
						  ISO/IEC 17025, ISO Guide 34, an ILAC recognized signatory, a CIPM recognized
						  National Metrology Institute (NMI), or a state weights and measures facility
						  that is part of the NIST laboratory metrology program. Calibration certificates
						  shall be endorsed by a recognized accreditation body symbol or otherwise make
						  reference to accredited status by a specific, recognized accreditation body, or
						  contain endorsement by the NMI. Certificates shall indicate traceability to the
						  SI or reference standard and include the measurement result with the associated
						  uncertainty of measurement.
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vii. Where traceability to the SI is not technically
						  possible or reasonable, the laboratory shall use certified reference materials
						  provided by a competent supplier.
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viii. Calibrations performed in-house shall be
						  documented in a manner that demonstrates traceability via an unbroken chain of
						  calibrations regarding the reference standard/material used, allowing for an
						  overall uncertainty to be estimated for the in-house calibration.
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ix. Calibrations shall be repeated at appropriate
						  intervals, the length of which can be dependent on the uncertainty required,
						  the frequency of use and verification, the manner of use, stability of the
						  equipment, and risk of failure considerations.
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x. Periodic verifications shall be performed to
						  demonstrate the continued validity of the calibration at specified intervals
						  between calibrations. The frequency of verifications can be dependent on the
						  uncertainty required, the frequency of use, the manner of use, stability of the
						  equipment, and risk of failure considerations.
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c. Documentation of curative maintenance in logbook,
						  signed and dated by laboratory director.
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d. Evidence of temperature monitoring for equipment
						  requiring specific temperature ranges.
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e. Test and calibration equipment, including both
						  hardware and software, shall be safeguarded from adjustments which would
						  invalidate the test and/or calibration results.
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f. Decontamination and cleaning procedures for:
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i. Instruments;
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ii. Bench space; and
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iii. Ventilation hood/microbial hood.
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g. Documentation of adequacy of training of personnel
						  and responsibility for each maintenance task.
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h. The organization shall describe or reference how
						  periodic preventive and corrective maintenance of measurement or test equipment
						  shall be performed to ensure availability and satisfactory performance of the
						  systems.
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23. Computer systems (items verified upon on-site
						  inspection).
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a. Adequate for sample tracking.
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b. Adequate for analytical equipment software.
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c. Software control requirements applicable to both
						  commercial and laboratory developed software shall be developed, documented,
						  and implemented.
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d. In addition, procedures for software control shall
						  address the security systems for the protection of applicable software.
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e. For laboratory-developed software, a copy of the
						  original program code shall be:
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i. Maintained;
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ii. All changes shall include a description of the
						  change, authorization for the change;
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iii. Test data that validates the change.
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f. Software shall be acceptance tested when installed,
						  after changes, and periodically during use, as appropriate.
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g. Software testing shall include performing manual
						  calculations or checking against another software product that has been
						  previously tested, or by analysis of standards.
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h. The version and manufacturer of the software shall
						  be documented.
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i. Commercially available software may be accepted as
						  supplied by the vendor. For vendor supplied instrument control/data analysis
						  software, acceptance testing may be performed by the laboratory.
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24. Security.
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a. Written facility security procedures during
						  operating and nonworking hours.
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b. Roles of personnel in security.
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c. SOP for controlled access areas and personnel who
						  can access.
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25. Control of records.
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a. The laboratory shall establish and maintain
						  procedures for identification, collection, indexing, access, filing, storage,
						  maintenance and disposal of quality and technical records.
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b. All records shall be legible and shall be stored and
						  retained in such a way that they are readily retrievable in facilities that
						  provide a suitable environment to prevent damage or deterioration and to
						  prevent loss.
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c. Records must be retained for a period of three
						  years.
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d. All records shall be held secure and in
						  confidence.
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e. The laboratory shall have procedures to protect and
						  back-up records stored electronically and to prevent unauthorized access to or
						  amendment of these records.
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f. The laboratory shall retain records of original
						  observations, derived data and sufficient information to establish an audit
						  trail, calibration records, staff records and a copy of each test report or
						  calibration certificate issued, for a defined period.
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g. The records for each test or calibration shall
						  contain sufficient information to facilitate, if possible, identification of
						  factors affecting the uncertainty and to enable the test or calibration to be
						  repeated under conditions as close as possible to the original.
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h. The records shall include the identity of personnel
						  responsible for the sampling, performance of each test and/or calibration and
						  checking of results.
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i. Observations, data and calculations shall be
						  recorded at the time they are made and shall be identifiable to the specific
						  task.
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j. When mistakes occur in records, each mistake shall
						  be lined out, not erased or made illegible or deleted, and the correct value
						  entered alongside.
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k. All such alterations or corrections to records shall
						  be signed or initialed and dated by the person making the correction.
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l. In the case of records stored electronically,
						  equivalent measures shall be taken to avoid loss or change of original
						  data.
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m. All entries to hard copy laboratory records shall be
						  made using indelible ink. No correction fluid may be used on original
						  laboratory data records.
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n. Laboratories shall establish and maintain a data
						  review process beginning at sample receipt and extending through the report
						  process. The data review process shall be an independent review, conducted by a
						  qualified individual other than the analyst.
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o. The review process shall be documented before data
						  are reported.
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26. Storage.
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a. Appropriate and adequate for sample storage over
						  time. The laboratory shall monitor, control and record environmental conditions
						  as required by the relevant specifications, methods and procedures or where
						  they influence the quality of the results. Due attention shall be paid, for
						  example, to biological sterility, dust, electromagnetic disturbances, humidity,
						  electrical supply, temperature, and sound and vibration levels, as appropriate
						  to the technical activities concerned.
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b. Adequate storage of chemical reference
						  standards.
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c. Appropriate storage of any reagents: Fireproof
						  cabinet, separate cabinet for storage of any acids.
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d. Appropriate safe and secure storage of documents
						  etc., archiving, retrieval of, maintenance of and security of data for a period
						  of three years.
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QA PROGRAM AND
						  TESTING
Document Reference
Y
N
NA
Comments
27. Sampling/sample protocols must be consistent with
						  chapter 314-55 WAC, written and approved by the laboratory director, and must
						  include documented training.
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a. Demonstrate adequacy of the chain-of-custody,
						  including: Tracking upon receipt of sample including all personnel handling the
						  sample and documenting condition of the sample through a macroscopic and
						  foreign matter inspection.
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b. Macroscopic and foreign matter inspection - Fit for
						  purpose test. Scientifically valid testing methodology: Either AHP monograph
						  compliant or other third-party validation.
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c. Failed inspection of product: Tracking and
						  reporting.
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d. Return of failed product documentation and
						  tracking.
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e. Disposal of used/unused samples
						  documentation.
-
-
-
-
-
f. Sample preparation, extraction and dilution
						  SOP.
-
-
-
-
-
g. Demonstration of recovery for samples in various
						  matrices (SOPs):
-
-
-
-
-
i. Plant material - Flower;
-
-
-
-
-
ii. Edibles (solid and liquid meant to be consumed
						  orally);
-
-
-
-
-
iii. Topical;
-
-
-
-
-
iv. Concentrates.
-
-
-
-
-
28. Data protocols.
-
-
-
-
-
a. Calculations for quantification of cannabinoid
						  content in various matrices - SOPs.
-
-
-
-
-
b. Determination of the range for reporting the
						  quantity (LOD/ LOQ) data review or generation.
-
-
-
-
-
c. Reporting of data: Certificates of analysis (CA) -
						  Clear and standardized format for consumer reporting.
-
-
-
-
-
d. Each test report shall include at least the
						  following information, unless the laboratory has valid reasons for not doing
						  so:
-
-
-
-
-
i. A title (e.g., "Test Report" or "Certificate of
						  Analysis");
-
-
-
-
-
ii. The name and address of the laboratory, and the
						  location where the tests were carried out, if different from the address of the
						  laboratory;
-
-
-
-
-
iii. Unique identification of the test report
						  certificate (such as the serial number), and on each page an identification in
						  order to ensure that the page is recognized as a part of the test report or
						  calibration certificate, and a clear identification of the end of the test
						  report or calibration certificate;
-
-
-
-
-
iv. The name and address of the customer;
-
-
-
-
-
v. Identification of the method used;
-
-
-
-
-
vi. A description of, the condition of, and unambiguous
						  identification of the item(s) tested;
-
-
-
-
-
vii. The date of receipt of the test item(s) where this
						  is critical to the validity and application of the results, and the date(s) of
						  performance of the test or calibration;
-
-
-
-
-
viii. Reference to the sampling plan and procedures
						  used by the laboratory or other bodies where these are relevant to the validity
						  or application of the results;
-
-
-
-
-
ix. The test results with, where appropriate, the units
						  of measurement;
-
-
-
-
-
x. The name(s), function(s) and signature(s) or
						  equivalent identification of person(s) authorizing the test report or
						  certificate; and
-
-
-
-
-
xi. Where relevant, a statement to the effect that the
						  results relate only to the items tested or calibrated.
-
-
-
-
-
e. Material amendments to a test report or calibration
						  certificate after issue shall be made only in the form of a further document,
						  or data transfer, which includes the statement: "Supplement to Test Report (or
						  Calibration Certificate), serial number... (or as otherwise identified)," or an
						  equivalent form of wording.
-
-
-
-
-
f. When it is necessary to issue a complete new test
						  report or calibration certificate, this shall be uniquely identified and shall
						  contain a reference to the original that it replaces.
-
-
-
-
-
g. If the laboratory chooses to include a reference to
						  their I-502 certification on their test report, any test results not covered
						  under I-502 certification shall be clearly identified on the report.
-
-
-
-
-
h. Documentation that the value reported in the CA is
						  within the range and limitations of the analytical method.
-
-
-
-
-
i. Documentation that qualitative results (those below
						  the LOQ but above the LOD) are reported as "trace," or with a nonspecific
						  (numerical) designation.
-
-
-
-
-
j. Documentation that the methodology has the
						  specificity for the degree of quantitation reported. Final reports are not
						  quantitative to any tenths or hundredths of a percent.
-
-
-
-
-
k. Use of appropriate "controls": Documentation of
						  daily use of positive and negative controls that challenge the linearity of the
						  curve; and/or an appropriate "matrix blank" and control with documentation of
						  the performance for each calibration run.
-
-
-
-
-
29. Chemical assay procedure/methodology.
-
-
-
-
-
30. Quality Control (QC):
-
-
-
-
-
a. Documentation of use of an appropriate internal
						  standard for any quantitative measurements as applicable to the method.
-
-
-
-
-
b. Appropriate reference standards for quantification
						  of analytes, performing and documenting a calibration curve with each
						  analysis.
-
-
-
-
-
i. Reference materials shall, where possible, be
						  traceable to SI units of measurement, or to certified reference materials.
						  Internal reference materials shall be checked for accuracy as far as is
						  technically and economically practicable.
-
-
-
-
-
ii. The laboratory shall create and follow procedures
						  for safe handling, transport, storage and use of reference standards and
						  reference materials in order to prevent contamination or deterioration and in
						  order to protect their integrity.
-
-
-
-
-
iii. Reference materials shall have a certificate of
						  analysis that documents traceability to a primary standard or certified
						  reference material and associated uncertainty, when possible. When applicable,
						  the certificate must document the specific NIST SRM or NMI certified reference
						  material used for traceability.
-
-
-
-
-
c. Demonstration of calibration curve
						  r2 value of no less than 0.995 with a minimum of
						  four points which bracket the expected sample concentration range.
-
-
-
-
-
i. The calibration curve shall be verified by preparing
						  an independently prepared calibration standard (from neat materials) or with a
						  standard from an independent source. Acceptance criteria for the standard
						  calibration curve and the independent calibration verification standard shall
						  be documented.
-
-
-
-
-
ii. Instrument calibration/standardization shall be
						  verified each 24-hour period of use, or at each instrument start-up if the
						  instrument is restarted during the 24-hour period, by analysis of a continuing
						  calibration verification standard. Acceptance criteria shall be
						  documented.
-
-
-
-
-
iii. Calibration or working quantification ranges shall
						  encompass the concentrations reported by the laboratory. Continuing calibration
						  verification standards and continuing calibration blanks shall be analyzed in
						  accordance with the specified test methods. Acceptance criteria shall be
						  documented.
-
-
-
-
-
d. Assuring the quality of test results.
-
-
-
-
-
i. The laboratory shall have quality control procedures
						  for monitoring the validity of tests and calibrations undertaken.
-
-
-
-
-
ii. The resulting data shall be recorded in such a way
						  that trends are detectable and, where practicable, statistical techniques shall
						  be applied to the reviewing of the results.
-
-
-
-
-
iii. This monitoring shall be planned and reviewed and
						  may include, but not be limited to, the following:
-
-
-
-
-
A. Regular use of certified reference materials and/or
						  internal quality control using secondary reference materials;
-
-
-
-
-
B. Participation in interlaboratory comparison or
						  proficiency-testing programs;
-
-
-
-
-
C. Replicate tests or calibrations using the same or
						  different methods;
-
-
-
-
-
D. Retesting or recalibration of retained items;
-
-
-
-
-
E. Correlation of results for different characteristics
						  of an item.
-
-
-
-
-
iv. Quality control data shall be analyzed and, where
						  they are found to be outside predefined criteria, planned actions shall be
						  taken to correct the problem and to prevent incorrect results from
						  occurring.
-
-
-
-
-
v. The laboratory shall determine, where feasible, the
						  accuracy and precision of all analyses performed.
-
-
-
-
-
vi. Acceptance limits for each method shall be
						  established based on statistical evaluation of the data generated by the
						  analysis of quality control check samples, unless specific acceptance limits
						  are established by the method.
-
-
-
-
-
vii. Control charts or quality control data bases shall
						  be used to record quality control data and compare them with acceptance
						  limits.
-
-
-
-
-
viii. Procedures shall be used to monitor trends and
						  the validity of test results.
-
-
-
-
-
31. Proficiency.
-
-
-
-
-
a. Participation in approved PT programs for each field
						  of testing.
-
-
-
-
-
b. Passing PT results for two consecutive PTs.
-
-
-
-
-
c. Documentation of investigation for all failed
						  PTs.
-
-
-
-
-
32. Method validation: Scientifically valid testing
						  methodology: AHP monograph compliant, other third-party validation
or
the current version of a standard method. The following
						  requirements are applied to other third-party validation:
-
-
-
-
-
a. The laboratory shall validate nonstandard methods,
						  laboratory-designed/developed methods, standard methods used outside their
						  intended scope, and amplifications and modifications of standard methods to
						  confirm that the methods are fit for the intended use.
-
-
-
-
-
b. The validation shall be as extensive as is necessary
						  to meet the needs of a given application or field of application.
-
-
-
-
-
c. The laboratory shall record the results obtained,
						  the procedure used for the validation, and a statement as to whether the method
						  is fit for the intended use.
-
-
-
-
-
d. The customer shall be informed as to the method
						  chosen.
-
-
-
-
-
e. The laboratory shall confirm that it can properly
						  operate standard methods before introducing the tests or calibrations. If the
						  standard method changes, the confirmation shall be repeated.
-
-
-
-
-
f. Deviation from test and calibration methods shall
						  occur only if the deviation has been documented, technically justified,
						  authorized, and accepted by the customer.
-
-
-
-
-
g. Validation shall be documented and include the
						  following elements as applicable:
-
-
-
-
-
i. Minimum acceptance criteria;
-
-
-
-
-
ii. Analyte specificity;
-
-
-
-
-
iii. Linearity;
-
-
-
-
-
iv. Range;
-
-
-
-
-
v. Accuracy;
-
-
-
-
-
vi. Precision;
-
-
-
-
-
vii. Detection limit;
-
-
-
-
-
viii. Quantification limit;
-
-
-
-
-
ix. Stability of samples and reagents interlaboratory
						  precision;
-
-
-
-
-
x. Analysis robustness;
-
-
-
-
-
xi. Presence of QC samples;
-
-
-
-
-
xii. Use of appropriate internal reference
						  standard;
-
-
-
-
-
xiii. Daily monitoring of the response of the
						  instrument;
-
-
-
-
-
h. Validation shall be performed for matrix extensions
						  for each type of product tested, including data review of recovery for:
-
-
-
-
-
i. Solvent-based extract;
-
-
-
-
-
ii. CO2 extraction or other
						  "hash oil";
-
-
-
-
-
iii. Extract made with food grade ethanol;
-
-
-
-
-
iv. Extract made with food grade glycerin or propylene
						  glycol;
-
-
-
-
-
v. Infused liquids;
-
-
-
-
-
vi. Infused solids;
-
-
-
-
-
vii. Infused topical preparations;
-
-
-
-
-
viii. Other oils, butter or fats.
-
-
-
-
-
33. Estimation of uncertainty of measurement.
-
-
-
-
-
a. Testing laboratories shall have and shall apply
						  procedures for estimating uncertainty of measurement. The laboratory shall at
						  least attempt to identify all the components of uncertainty and make a
						  reasonable estimation, and shall ensure that the form of reporting of the
						  result does not give a wrong impression of the uncertainty. Reasonable
						  estimation shall be based on knowledge of the performance of the method and on
						  the measurement scope and shall make use of, for example, previous experience
						  and validation data.
-
-
-
-
-
b. In those cases where a well-recognized test method
						  specifies limits to the values of the major sources of uncertainty of
						  measurement and specifies the form of presentation of calculated results, the
						  laboratory is considered to have satisfied this clause by following the test
						  method and reporting instructions.
-
-
-
-
-
c. When estimating the uncertainty of measurement, all
						  uncertainty components which are of importance in the given situation shall be
						  taken into account using appropriate methods of analysis.
-
-
-
-
-
d. Sources contributing to the uncertainty include, but
						  are not necessarily limited to, the reference standards and reference materials
						  used, methods and equipment used, environmental conditions, properties and
						  condition of the item being tested or calibrated, and the operator.
-
-
-
-
-
e. Test methods are classified as either qualitative or
						  quantitative. Qualitative tests are defined as having nonnumerical results.
						  Although estimation of measurement uncertainty is not needed for these tests,
						  laboratories are expected to have an understanding of the contributors to
						  variability of the results. For quantitative tests, laboratories shall
						  determine measurement uncertainty using appropriate statistical
						  techniques.
-
-
-
-
-
f. Laboratories shall make independent estimations of
						  uncertainty for tests performed on samples with significantly different
						  matrices.
-
-
-
-
-
g. Laboratories are required to re-estimate measurement
						  uncertainty when changes to their operations are made that may affect sources
						  of uncertainty.
-
-
-
-
-
h. When reporting measurement uncertainty, the test
						  report shall include the coverage factor and confidence level used in the
						  estimations (typically k = approximately 2 at the 95% confidence level).
-
-
-
-
-
34. Other methods.
-
-
-
-
-
a. Validated microbiological methods fit for
						  purpose.
-
-
-
-
-
b. Microbial contaminants within limits as directed by
						  WSLCB.
-
-
-
-
-
c. Moisture content testing fit for purpose.
						  Scientifically valid testing methodology: AHP monograph compliant, or other
						  third-party validation.
-
-
-
-
-
d. Solvent residuals testing fit for purpose; solvent
						  extracted products made with class 3 or other solvents used are not to exceed
						  500 parts per million (PPM) per one gram of solvent based product and are to be
						  tested.
-
-
-
-
-
e. Any other QA/QC methods is proven to be fit for
						  purpose.
-
-
-
-
-
35. Laboratory records.
-
-
-
-
-
a. Legible and in ink (or computerized system).
-
-
-
-
-
b. Signed and dated.
-
-
-
-
-
c. Changes initialed and dated.
-
-
-
-
-
d. Evidence of periodic review and signed by a
						  management representative.
-
-
-
-
-
36. Preventive/corrective action.
-
-
-
-
-
The laboratory shall establish a policy and procedure
						  and shall designate appropriate authorities for implementing corrective action
						  when nonconforming work or departures from the policies and procedures in the
						  management system or technical operations are identified.
-
-
-
-
-
a. The procedure for corrective action shall start with
						  an investigation to determine the root cause(s) of the problem.
-
-
-
-
-
b. Where corrective action is needed, the laboratory
						  shall identify potential corrective actions. It shall select and implement the
						  action(s) most likely to eliminate the problem and to prevent
						  recurrence.
-
-
-
-
-
c. The laboratory shall document and implement any
						  required changes resulting from corrective action investigations.
-
-
-
-
-
d. Any PT round that leads to the nonproficient status
						  of a laboratory shall be addressed by the corrective action process.
-
-
-
-
-
e. The laboratory shall monitor the results to ensure
						  that the corrective actions taken have been effective.
-
-
-
-
-
f. When improvement opportunities are identified or if
						  preventive action is required, action plans shall be developed, implemented and
						  monitored to reduce the likelihood of the occurrence of such nonconformities
						  and to take advantage of the opportunities for improvement.
-
-
-
-
-
37. Complaints.
-
-
-
-
-
a. The laboratory shall have a policy and procedure for
						  the resolution of complaints received from customers or other parties.
-
-
-
-
-
b. Records shall be maintained of all complaints and of
						  the investigations and corrective actions taken by the laboratory.
-
-
-
-
-
c. Test reports.
-
-
-
-
-
d. Each test report or calibration certificate shall
						  include at least the following information, unless otherwise justified:
-
-
-
-
-
i. A title (e.g., "Test Report" or "Calibration
						  Certificate");
-
-
-
-
-
ii. The name and address of the laboratory, and the
						  location where the tests and/or calibrations were carried out, if different
						  from the address of the laboratory;
-
-
-
-
-
iii. Unique identification of the test report or
						  calibration certificate (such as the serial number), and on each page an
						  identification in order to ensure that the page is recognized as a part of the
						  test report or calibration certificate, and a clear identification of the end
						  of the test report or calibration certificate;
-
-
-
-
-
iv. The name and address of the customer;
-
-
-
-
-
v. Identification of the method used;
-
-
-
-
-
vi. A description of, the condition of, and unambiguous
						  identification of the item(s) tested or calibrated;
-
-
-
-
-
vii. The date of receipt of the test or calibration
						  item(s) where this is critical to the validity and application of the results,
						  and the date(s) of performance of the test or calibration;
-
-
-
-
-
viii. Reference to the sampling plan and procedures
						  used by the laboratory or other bodies where these are relevant to the validity
						  or application of the results;
-
-
-
-
-
ix. The test or calibration results with, where
						  appropriate, the units of measurement;
-
-
-
-
-
x. The name(s), function(s) and signature(s) or
						  equivalent identification of person(s) authorizing the test report or
						  calibration certificate; and
-
-
-
-
-
xi. Where relevant, a statement to the effect that the
						  results relate only to the items tested or calibrated.
-
-
-
-
-
38. Periodic management review and internal
						  audit.
-
-
-
-
-
a. Laboratory management shall annually review its
						  quality system and associated procedures to evaluate continued adequacy. This
						  review shall be documented.
-
-
-
-
-
b. Periodically and in accordance with a predetermined
						  schedule perform an internal audit of laboratory operations to verify
						  compliance to the GLP checklist.
-
-
-
-
-