La. Admin. Code tit. 33 § I-5101

Current through Register Vol. 50, No. 9, September 20, 2024

Section I-5101 - Inspection Procedures

A. The authorized representative(s) of the department shall schedule the initial on-site inspection with the applicant laboratory. The authorized representative(s) of the department may make an announced or unannounced inspection or examination of an accredited laboratory whenever the department, in its discretion, considers such an inspection or examination necessary to determine the extent of the laboratory's compliance with the conditions of its accreditation and these regulations. Any refusal to allow entry to this representative shall constitute a violation of a condition of accreditation and is grounds for discreditation. The laboratory shall provide appropriate safety equipment for the department representative(s) when required.

B. Additional inspections may be conducted when evaluations and submissions from the laboratory or its clients indicate significant technical changes in the capability of the laboratory have occurred.

C. The following shall be available for review at the laboratory:

1. quality assurance plan;

2. approved methodology manual;

3. quality assurance data; and

4. proficiency test data.

D. During inspections, consideration will be given to:

1. competence of the staff;

2. working conditions, including adequacy of space;

3. lighting, equipment, and supplies;

4. efficient organization of the laboratory;

5. testing or analytical methods used;

6. quality control procedures;

7. maintenance of all required records; and

8. compliance with all the requirements of these regulations.

E. Laboratory inspection will follow this general outline:

1. an entry briefing with laboratory management;

2. review of quality documentation, sample handling, and records, such as typical lab results and reports of test data;

3. interviews with technical staff;

4. demonstration of selected tests, as necessary;

5. examination of equipment and calibration records;

6. an exit briefing including the specific identification of any deficiencies; and

7. a written report of inspection findings to be forwarded to the laboratory within 60 working days after the on-site visit.

La. Admin. Code tit. 33, § I-5101

Promulgated by the Department of Environmental Quality, Office of the Secretary, LR 24:923 (May 1998).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2011.