Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis
Section 216-RICR-60-05-6.11 - Quality Assurance and Quality Control Programs

Universal Citation: 216 RI Code of Rules 60 05 6.11

Current through September 18, 2024

A. The laboratory must have a quality assurance plan that details the quality assurance system of quality control requirements in its standard operating procedures and document that all personnel review the quality assurance plan annually. The analytical laboratory must follow all applicable quality control activities described in its quality assurance plan as approved by the RIDOH. Analytical laboratories must review their quality assurance plan annually and provide a copy of the updated quality assurance plan to the RIDOH with the annual renewal application.

B. Each laboratory must have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results. These quality controls must consider such factors as preventative maintenance, periodic inspection, testing for proper validation of methods, evaluation of reagents and volumetric equipment, surveillance of results, remedial action taken to correct deficiencies and quality control failures and other factors as may be deemed necessary.

C. The laboratory must perform all analyses using methods that are currently approved by the RIDOH, as described in § 6.21 of this Part.

D. The laboratory's quality assurance plan must be accessible to all personnel in the laboratory. It must include, but not be limited to:

1. Laboratory sampling plan for collecting representative samples of finished cannabis products;

2. Laboratory sample handling procedures;

3. Emergency sampling and handling plan;

4. Laboratory glassware, plastic ware and equipment washing and sterilizing procedures;

5. Instrument calibration procedures;

6. A list of detailed analytical procedures or analytical references;

7. Data reduction, validation, and reporting procedures including non-compliance action plan;

8. Types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);

9. Internal audit procedures and frequency;

10. Preventative maintenance procedures and schedules;

11. Procedures for determining accuracy and precision and method detection limits of all analytes and specified frequency;

12. Control limits and corrective action policies;

13. Laboratory organization, staff, and responsibilities;

14. Procedures for laboratory and managerial data review;

15. Detection limits (DL) for cannabinoids, and contaminant analytes specified in these regulations must be determined by DL studies prior to placing new methods in service and annually thereafter. The resulting detection limits must be less than half of the Upper Limit concentration criteria specified in these regulations. If the laboratory cannot meet a DL that is less than half of the Upper Limit for an analyte, a request for a variance must be submitted;

16. The applicable quality control procedures required for methodologies described by the FDA, AOAC, AHP or USP.

Disclaimer: These regulations may not be the most recent version. Rhode Island may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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