Contents

5. Quality Control

Effective Date: 08/06
Point of Contact: Quality Engineer for Regulatory Programs

Quality control (QC) is defined as the overall system that provides measures of the quality of an analytical result. QC data are evaluated against client requirements to measure how well the data meets the client's needs. Project QC is conducted with the objectives of demonstrating the performance capabilities and limitations for each analytical process and of confirming the degree to which the client's data quality requirements are met. This section provides the minimum QC necessary for evaluating an analytical result.

Project staff perform the following steps.

Step 1 For general laboratory quality control requirements (e.g. solvents, gases, reagents, water) applicable to all analyses, see General Laboratory Quality Control exhibit.

Step 2 For inorganic quality control, see the following exhibits for additional requirements:

• The Inorganic Quality Control exhibit describes preparative and analytical techniques.
• The Inorganic Preparative Quality Control Requirements exhibit provides frequency and acceptance criteria for inorganic preparative quality control.
• The Inorganic Analytical Quality Control Requirements exhibit provides frequency and acceptance criteria for inorganic analytical quality control.

Step 3 For organic quality control, see the following exhibits for additional requirements:

• The Organic Quality Control exhibit describes preparative and analytical techniques.
• The Preparative Requirements for Volatile, Semivolatile, and Gas Chromatrography Quality Control exhibit provides the frequency and acceptance criteria requirements for organic preparative quality control.
• The following exhibits provide frequency and acceptance criteria requirements for analytical quality control:
• Analytical Requirements for Gas Chromatography
• Analytical Requirements for Semivolatile (Gas Chromatography/Mass Spectrometry) Quality Control
• Analytical Requirements for Total Carbon, Total Inorganic Carbon, and Total Organic Compound Quality Control
• Analytical Requirements for Volatile (Gas Chromatography/Mass Spectrometry) Quality Control.

Step 4 For radiochemistry quality control, see the following exhibits for additional requirements:

• The Radiochemistry Quality Control exhibit describes preparative and analytical techniques.
• The Preparative and Analytical Requirements for Radiochemistry Quality Control exhibit provides frequency and acceptance criteria for radiochemistry quality control.

Step 5 For physical chemistry quality control, see the Physical Testing Quality Control (Differential Scanning Calorimetry, Thermogravimetric Analysis, and Differential Thermal Analysis/Thermogravimetric Analysis) exhibit for additional requirements.