Laboratory quality assurance

Quality assurance is a set of operating principles that enable laboratories to produce defensible data of known accuracy and precision. These operating principles that form laboratory quality system are documented in the Laboratory QA Manual, in a set of laboratory SOPs, and in various laboratory records. 

Two elements of quality assurance are quality control and quality assessment. Quality control is a set of measures implemented within an analytical procedure to assure that the process is in control. A combination of these measures constitutes the laboratory QC program. A properly designed and executed QC program will result in a measurement system operating in a state of statistical control, which means that errors have been reduced to acceptable levels. An effective QC program includes the following elements  

Quality assessment is the process used by the laboratory to ensure that the QC measures are implemented correctly and that the quality of produced data is determined. Included 

Every member of laboratory operations is responsible for the implementation of the QC program, whereas QA oversight is conducted by the QA section staff and is independent of laboratory operations. 

A typical data user is only interested in those QC checks that determine the quality of a particular set of data. Internal laboratory processes, such as initial demonstration of capability or corrective action, are not a concern of a data user unless a gross analytical error has been discovered that casts doubt over the elfectiveness of the laboratory quality system. 

---

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

EPA Environmental Monitoring Systems Laboratory, Quality Assurance... 

Because of the status of the CAC described above, the work that it has carried out in the area of laboratory quality assurance must be carefully considered. One of the CAC Committees, the Codex Committee on Methods of Analysis and Sampling (CCMAS), has developed criteria for assessing the competence of testing laboratories involved in the official import and export control of foods. These were recommended by the Committee at its 21st Session in March 19979 and adopted by the Codex Alimentarius Commission at its 22nd Session in June 1997 10 they mirror the EU recommendations for laboratory quality standards and methods of analysis. The guidelines provide a framework for the implementation of quality assurance measures to ensure the competence of testing laboratories involved in the import and export control of foods. They are intended to assist countries in then-fair trade in foodstuffs and to protect consumers. 

Laboratory Quality Assurance Support -Generation of audit trails. 

Field and laboratory quality assurance/quality control... 

Table II. Evaluation of Laboratory Quality Assurance Unit...

B. Quality Assurance Program is the responsibility of a QA Officer who in turn is chairperson of a QA Committee. The elements of the QA Program are presented in the "Laboratory Quality Assurance Manual." August 1986. 

The Analytical Laboratory staff should become involved in implementing the entire contents of the "Laboratory Quality Assurance Manual," as written, or change those criteria that are impossible or of no value. 

T.A. Ratliff, The Laboratory Quality Assurance System A Manual of Quality Procedures and Forms, Van Nostrand Reinhold, New York, 1993. 

The Technical Services function of AOCS establishes, revises, and annually updates AOCS Methods, the Official Methods and Recommenced Practices of the American Oil Chemists Society22 for fats, oils, and soap technology Spanish AOCS Methods, a Spanish translation of the more commonly used AOCS Methods and Physical and Chemical Characteristics of Oils, Fats and Waxes. Leaders of the methods development committees coordinate closely with AOAC International (formerly the Association of Official Analytical Chemists). AOCS Methods are recognized as Official Methods in US FDA activities and when litigation becomes necessary in industry trade. Additionally, the Technical Services function operates a Laboratory Proficiency Program (formerly the Smalley Check Sample Program) and oversees distribution and statistical analysis of 30 different series of basic laboratory quality assur-ance/quality control test samples. Certification as AOCS Approved Chemists, or as AOCS... 

Point 1 is usually well covered in laboratory quality assurance procedures, point 2 is sometimes assessed in research publications that report sensitivity, specificity, predictive values and related parameters, but points 3 and 4 are often not formally evaluated at aU, despite being key to determining whether or not a test actually produces a benefit. 

Flowers RS, Gecan JS, Pusch DJ (1992) Laboratory quality assurance. 

This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions and require-... 

Unfortunately DG III and DG VI are following totally different approaches to legislation, laboratory quality assurance and test method or test result validation ... 

Laboratory quality assurance system for notification to the EC-Commission Yes, Art. 3 of Directive 93/99/EEC EN 45000 series, additional measures of OECD-GLP principles No... 

Different T3 immunoassays may show unexplained discrepancies between values for the same sera. Results from inter-laboratory quality assurance schemes also demonstrate a higher analytical variance for T3 than for T4 methods. Many factors have been suggested as accounting for these disparities, such as the lower quantity of T3 in sera, differences in antisera cross-reactivity, protein interferences, and different assay limits of detection. ... 

To have a real impact on the quality of the laboratory performance the participation in interlaboratory performance studies should be done on a regular basis and should be an integral part of the laboratory quality assurance and quality control system. The common project of lUPAC/AOAC/ISO, leading to a harmonised protocol [3] gives several indications and recommendations on the organisation and evaluation of such interlaboratory studies. 

ACassurance is the quality assurance expert system that will be used by the MANAGER and the ANALYST to assist in the execution of a laboratory quality assurance program. Incorporated into this expert system are modules that will be used to provide instruction and advice to the laboratory personnel in carrying out their tasks and completing the analysis procedures. ACanalyst, the quality control and process control expert system, will comprise five modules that will be used in methods selection, process control, analysis, fault diagnosis, and quality control. 

J. A. Lott and S. T. Patel, Assessment of Analytical Variability in Clinical Chemistry, in Laboratory Quality Assurance, (eds. P. J. HowanitzandJ. H. Howanitz), McGraw-Hill, New York,... 

---