La. Admin. Code tit. 48 § V-8063

Current through Register Vol. 50, No. 11, November 20, 2024

Section V-8063 - Management Systems General Requirements

A. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses shall establish, implement and maintain a management system. The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality assurance plan (however named). The quality assurance plan shall include all the requirements in the USEPA Manual for the Certification of Laboratories Analyzing Drinking Water. The quality assurance plan shall be made available to all laboratory personnel.

B. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses shall establish and maintain a documented data integrity system. There are four elements within a data integrity system. These are:

1. data integrity training;

2. signed data integrity documentation for all laboratory employees;

3. in-depth, periodic monitoring of data integrity; and

4. data integrity procedure documentation.

C. The procedures of the data integrity system required under Subsection B of this Section shall be signed by top management.

D. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses, shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints and all analytical methods. All quality control data and records required by this Section shall be retained by the laboratory for a minimum of 10 years and shall be made available for inspection by the department. Such retained data shall include, but shall not be limited to, the results of and raw data generated by PT analyses.

E. Control of Nonconforming Environmental Testing Work. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses shall meet the requirements for the control of nonconforming environmental testing pursuant to the USEPA Manual for the Certification of Laboratories Analyzing Drinking Water.

F. Laboratory Improvement, Corrective Action and Preventive Action. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses shall meet the requirements for improving the laboratory, and implementing corrective and preventive actions pursuant to the USEPA Manual for the Certification of Laboratories Analyzing Drinking Water.

G. Internal Audits. Laboratories which have received certification or are seeking certification to perform any of the required chemical analyses shall meet the requirements for establishing and conducting internal audits of laboratory activities pursuant to the USEPA Manual for the Certification of Laboratories Analyzing Drinking Water.

La. Admin. Code tit. 48, § V-8063

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 38:3227 (December 2012), Amended by the Department of Health, Office of Public Health, LR 461098 (8/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 36:254(B)(7).