La. Admin. Code tit. 33 § I-5301

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

Section I-5301 - Quality Assurance/Quality Control Requirements

A. Each laboratory seeking accreditation shall maintain their Quality Assurance/Quality Control (QA/QC) program using appropriate document control practices. The quality assurance manual, analytical methods, and administrative procedures necessary to meet requirements of these regulations shall be reviewed for accuracy and approved for release by the appropriate personnel, distributed, and controlled to ensure the use of the current approved version. Each laboratory seeking accreditation shall:

1. have documented quality control procedures in use for each analytical procedure;

2. comply with all quality control procedures required by applicable federal, state, or public health agencies when performing analyses; and

3. have procedures to be followed for feedback and corrective action whenever testing discrepancies are detected or departures from documented policies and procedures occur.

B. The laboratory shall operate an internal quality assurance program appropriate to the type, range, and volume of work performed. A person/persons having responsibility for quality assurance within the laboratory shall be designated by the laboratory management and have direct access to top management.

C. The quality assurance program shall be documented in a quality assurance manual that is available for use by the laboratory staff. The quality assurance manual shall be maintained by the quality assurance manager. The quality assurance manual shall contain information regarding:

1. the structure of the laboratory (organizational charts and generic position descriptions) including relationship between management, technical operations, support services, and quality systems;

2. the operational and functional duties and services pertaining to quality assurance, so that each person concerned knows the extent and the limits of his/her responsibility;

3. general quality assurance procedures;

4. procedures for feedback and corrective action whenever testing discrepancies are detected;

5. chain of custody procedures;

6. a quality policy statement, including objectives and commitments, by management;

7. references to procedures for the control and maintenance of documents, including document control of laboratory notebooks, instrument logbooks, standards logbooks, and records for data reduction, validation, storage, and reporting;

8. the laboratory's procedures for achieving traceability of measurements to NIST reference materials or other traceable commercial vendors;

9. the laboratory's scope of tests;

10. references to procedures for handling submitted samples;

11. references to major equipment, as well as the facilities and services used by the laboratory;

12. references to procedures for calibration, verification, and maintenance of equipment;

13. references to verification practices including interlaboratory comparisons, proficiency testing programs, use of reference materials, and internal quality control schemes;

14. the laboratory management arrangements for departures from documented policies and procedures or from standard specifications;

15. references to policy and procedures for the resolution of complaints received from clients or other parties. Records of the complaint and subsequent action shall be maintained;

16. references to procedures for protecting confidentiality and proprietary rights;

17. references to procedures for audit and review;

18. identification of the laboratory's approved signatories; at a minimum, the title page of the quality assurance manual must have the signed and dated concurrence (with appropriate titles) of all responsible parties, including the quality assurance officer(s), technical director, and the laboratory manager;

19. references to processes/procedures for educating and training personnel in their ethical and legal responsibilities, including potential punishment and penalties for improper, unethical, or illegal actions;

20. references to processes/procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and/or receive any needed training;

21. references to procedures for reporting analytical results; and

22. a table of contents and applicable lists of references, glossaries, and appendices.

D. The quality assurance system shall be reviewed annually by management to ensure its continued effectiveness. Such reviews shall be documented with details of any changes.

E. The laboratory shall conduct annual internal audits to verify the compliance with the laboratory's quality system. The quality assurance officer shall be responsible for planning and organizing audits. Personnel shall not audit their own activities.

F. Standard operating procedures (SOPs) shall be kept in a manual available to the analyst and the inspector. SOPs may be included as a part or section of the laboratory's quality assurance manual. The laboratory shall have clearly defined, written SOPs or an equivalent, addressing, at a minimum, and as appropriate:

1. methods of analysis:

a. identification of the test method;

b. applicable matrix or matrices;

c. detection limit;

d. scope and application, including components to be analyzed;

e. summary of test method;

f. definitions;

g. safety;

h. equipment and supplies;

i. reagents and standards;

j. sample collection, preservation, storage, handling, and chain of custody;

k. quality control;

l. calibration;

m. procedure;

n. calculations;

o. method performance;

p. pollution prevention;

q. data assessment and acceptance criteria for quality control measures;

r. corrective actions for out-of-control or unacceptable data;

s. contingencies for handling out-of-control or unacceptable data;

t. waste management;

u. references; and

v. any tables, diagrams, flowcharts, and validation data;

2. procurement and inventory procedures;

3. preventive maintenance;

4. recordkeeping and record storage (archives);

5. data reduction, validation, and reporting;

6. correcting erroneous reports;

7. management of laboratory wastes and hazardous materials; and

8. complaints registered against the laboratory's testing procedures, reporting procedures, and/or other general operating procedures.

G. Supervisory staff shall be responsible for quality assurance/quality control implementation and compliance.

H. The following general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (e.g., chemical, microbiological, radiological). The standards for any given test type shall assure that the following applicable principles are addressed:

1. all laboratories shall have protocols in place to monitor the following quality controls:

a. adequate controls to monitor tests such as blanks, spikes, or reference toxicants;

b. adequate tests to define the variability and/or reproducibility of the laboratory results such as duplicates;

c. measures to ensure the accuracy of the test data, including sufficient calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures;

d. measures to evaluate test performance, such as method detection limits, or range of applicability such as linearity;

e. selection of appropriate formulae to reduce raw data to final results such as linear regression, internal standards, or statistical packages;

f. selection and use of reagents and standards of appropriate quality; and

g. measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the method, such as temperature, humidity, light, or specific instrument conditions;

2. all quality control measures shall be assessed and evaluated on an ongoing basis, and quality control acceptance limits shall be used to determine the validity of the data. The acceptance/rejection criteria shall be updated at a frequency established by the method or by the department's standards;

3. the laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exists; and

4. the method-specified and/or method-recommended quality control protocols shall be followed. The essential standards shall be used if no protocols are written into the method or if the method protocols are less stringent.

La. Admin. Code tit. 33, § I-5301

Promulgated by the Department of Environmental Quality, Office of the Secretary, LR 24:925 (May 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:1437 (July 2000).

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