Cal. Code Regs. Tit. 4, § 15729 - Laboratory Quality Assurance (LQA) Program

(a) The licensed laboratory shall develop and implement a LQA program to assure the reliability and validity of the analytical data produced by the laboratory. The LQA program shall, at minimum, include a written LQA manual that addresses the following:

(1) Quality control procedures;

(2) Laboratory organization and employee training and responsibilities, including good laboratory practice (GLP);

(3) LQA objectives for measurement data;

(4) Traceability of data and analytical results;

(5) Instrument maintenance, calibration procedures, and frequency;

(6) Performance and system audits;

(7) Corrective action procedures;

(8) Steps to change processes when necessary;

(9) Record retention and document control;

(10) Test procedure standardization; and

(11) Method validation.

(b) The supervisory or management laboratory employee shall annually review, amend if necessary, and approve the LQA program and manual both when they are created and when there is a change in methods, laboratory equipment, or the supervisory or management laboratory employee.

Notes

Cal. Code Regs. Tit. 4, § 15729

1. Change without regulatory effect relocating article 7 from title 16, division 42, chapter 6 and renumbering former title 16, section 5729 to new title 4, section 15729 filed 7-14-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 29). For prior history of title 16, division 42, see Register 2019, No. 3.
2. Amendment of subsection (a) filed 9-27-2021 as an emergency; operative 9-27-2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
3. Amendment of subsection (a) refiled 3-28-2022 as an emergency; operative 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-28-2022 order transmitted to OAL 9-26-2022 and filed 11-7-2022 (Register 2022, No. 45).

Note: Authority cited: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

1. Change without regulatory effect relocating article 7 from title 16, division 42, chapter 6 and renumbering former title 16, section 5729 to new title 4, section 15729 filed 7-14-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 29). For prior history of title 16, division 42, see Register 2019, No. 3.
2. Amendment of subsection (a) filed 9-27-2021 as an emergency; operative 9/27/2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
3. Amendment of subsection (a) refiled 3-28-2022 as an emergency; operative 3/28/2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-28-2022 order transmitted to OAL 9-26-2022 and filed 11/7/2022 (Register 2022, No. 45).