Objectives of a QA Manual

1. To determine the accuracy and precision of data performed by each analyst.
2. To determine the accuracy and precision of analytical methods.
3. Identify training needs for analysis.
4. To determine instrument performance.
5. To improve the overall performance of the laboratory.
6. To improve laboratory credibility.

Suggested outline for a writing a QA Plan

1. Table of contents.
2. Organizational chart with description of personnel, including experience and education.
3. Standard Operating Practices.
4. Methods and equipment/maintenance of equipment with a list of methods and list of maintenance schedules.
5. Quality control procedures used to monitor accuracy and precision, which included control charts.
6. Standardization of reagents and instruments.
7. Standard Operating Procedures for sample tracking and reporting.

Standard Operating Procedures for Sample Preparation

1. Brief description of sample preparation - Goals.
2. Equipment used and cleaning techniques. List types of grinders.
3. Sample protocol - numbering of samples.
4. Sample preparation that describes the sample preparation of samples including drying, splitting, grinding and mixing.
5. Sample storage and disposal, which includes the length of time stored.
6. Written procedure for sample disposal.

Standard Operating Procedures for Sample Tracking, & Reporting

1. Explain the sample tracking in your laboratory. It may be by log book, numbering, worksheets, LIMS or some other computer program.
2. Explain how raw data from worksheets transferred to the reporting format.
3. Explain report storage, retrieval and elimination.

Standard Operating Procedures for Analytical Methods

1. Scope of Method
2. References used for method
3. Principle and definitions
4. Reagents, solutions and standards
5. Apparatus
6. Sampling
7. Procedures for weighing
8. Standardization process, which includes reagents, method, calculation and calibration with known reference standards (NIST)
9. Expression of results with calculations and formulas
10. Documents with QC charts and worksheets
11. Quality Assurance Plan which includes performance standards (repeatability, reproducibility, quantitative and analytical range), control points (critical points and acceptable range), readiness to perform (training requirements) and infra-laboratory check samples.

Other Requirements

1. A warning letter will be issued when the laboratory exceeds 1.5 standard deviations. The laboratory must investigate reason for exceeding the 1.5 standard deviation and send a letter to the committee explaining actions taken.
2. When a laboratory falls below 11/12 check samples within 2 std, the laboratory must request an additional check sample from the committee. The sample will be analyzed and reported back to the committee. It must be within 2 std. If the results fail the following must be analyzed: 1.) Analyze 3 additional check samples, 2.) Submit a report to the committee explaining the actions taken and 3.) All samples submitted must be within 2 std.