Contents

General Laboratory Quality Control

Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs

The quality control described below represents the basic laboratory systems associated with analytical operations and applies to all analyses. The use of substandard reagents, standards, materials, and equipment can result in less reliable and unreliable data. Contamination from laboratory sources such as water, gases, and reagents shall be monitored. This monitoring will consist of the evaluation of analytical and preparative blanks.

Reagent Water

High-purity water is generally defined as water that has been distilled, deionized, or any combination of distillation, deionization, reverse osmosis, activated carbon filtration, ion exchange, particulate filtration, or other polishing techniques. However, the water used for client data collection activities shall be of sufficient quality for the operation performed. At a minimum, water quality shall be regularly monitored via preparative and analytical blank performance. The concentration of target analytes or interferences in the blanks shall be at a level that will not impact the results when using a particular analytical method. A procedure that addresses control of water quality may be necessary if additional requirements are applicable to the preparative or analytical methods being employed (e.g., organic-free water).

Compressed Gases

Gases used shall be of the proper type and sufficient quality for the intended use. The laboratory shall monitor the quality of gases to ensure they are adequate for the operation being performed. At a minimum, this shall consist of monitoring system performance (e.g., for contribution to background and/or blanks from impurities). These gases shall be procured in accordance with the Purchase Orders/Subcontracts subject area.

Reagents

All reagents used during sample analysis shall be of sufficient grade (e.g., American Chemical Society reagent grade, Pesticide grade) to meet the requirements of the analysis for which they will be used. These reagents shall be procured in accordance with the Purchase Orders/Subcontracts subject area. At a minimum, reagent quality shall be regularly monitored via preparative and analytical blank performance. A procedure that addresses control of reagent quality may be necessary if additional requirements are applicable to the preparative or analytical methods being employed.

Reagent Labeling

Reagents purchased or obtained from an external source generally are labeled by the manufacturer according to specific regulations. The date the container is first opened and the initials of the person opening the container shall be documented on the container. For limited life reagents, if the manufacturer's label does not contain an expiration date, an expiration date shall be specified by the cognizant scientist and documented on the reagent container.

All reagents prepared internally shall be labeled to include the following information, at a minimum:

If physical conditions (e.g., use in a hot cell, special size, shape, or form of the container) prevent recording complete information on the container, a unique identifier on the label or container shall be traceable by cross-reference to a readily accessible data record (e.g., log book, benchsheet, or reagents record binder).

Reagent Storage

All storage containers used shall protect reagents from contamination by impurities and change in composition. Containers of reagents requiring special treatment because of chemical or physical instability shall be marked to indicate this requirement.

Labware

The laboratory shall purchase and use labware of sufficient quality to meet procedure and/or client requirements. Labware selected shall be compatible with the testing performed.

Labware Cleaning

Labware shall be purchased pre-cleaned or the cleaning shall be performed in a manner that minimizes sample contamination. The minimum requirement for ensuring control over cleanliness is to monitor analytical and preparative blanks for contamination. A procedure that addresses labware cleaning may be necessary if additional requirements are applicable to the preparative or analytical methods being employed.

Good Housekeeping

The laboratory shall maintain operational areas in a clean and organized manner to minimize environmental impacts on samples.