Laboratory quality systems

The following recommendations represent integrated approaches to IQC that are suitable for many types of analysis and applications areas. Managers of laboratory quality systems will have to adapt the recommendations to the demands of their own particular requirements. Such adoption could be implemented, for example, by adjusting the number of duplicates and control material inserted into a run, or by the inclusion of any additional measures favoured in the particular application area. The procedure finally chosen and its accompanying decision rules must be... 

Different laboratories have different internal organizations, but all laboratories have two things in common the general process by which environmental samples are transformed into data, and a laboratory quality system. 

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. 

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. 

Before the designation, the laboratories developed their laboratory methods for testing, constructed and made operational their laboratory quality system and obtained its accreditation, and continued the participation and successful performance in the OPCW proficiency tests (PT). Analytical methods in particular and a certain level of quality assurance systems have existed in the laboratories, involved often in research, well before their designation. Participation in the international interlaboratory... 

This thus requires a sampling plan that reflects the data quality objectives and analytical measurement subjected to the laboratory quality system (Swyngedouw and Lessard, 2007). The measurement uncertainty can be controlled and evaluated (Eurachem, 2000). The sampling variance may contain systematic and random components of error from population representation and sampling protocol. Note that the errors are separate and additive. This means that the laboratory cannot compensate for sampling errors. 

The main similarities of GLP and other laboratory quality systems may be seen in their focus on apparatus and instrument suitability, maintenance and calibration, where the requirements of accreditation systems go beyond what GLP is regulating, since these issues are of the utmost importance for generating accurate, precise and reproducible results. Thus, it has to be possible in every case to trace back the calibrations to the respective national standards of measurement, and the quality control of the measurements has to ensure that trends to deviations form the precision required are detected already early on. 

Regardless of the standard on which it is based, some of the essential requirements for establishing a laboratory quality system are as follows ... 

A broad range of technical requirements is important in a laboratory quality system. These include aspects such as the selection of appropriately qualified and experienced personnel sampling, sample handling and preparation laboratory accommodation and environmental conditions equipment and reagents calibration reference standards and reference materials traceability (of standards and of samples) the selection or development, validation, and control of methods estimation of the uncertainty of measurements reporting of results and quality control and proficiency testing. 

Assessment of an analytical laboratory quality system may be made by the laboratory itself. It will have little or no value in the eyes of many customers, however, since it will be seen as a subjective and favorable assessment. However, internal audits and management reviews of the system, made as a requirement of a quality system standard, are self-assessments and are valuable, as explained in the previous section. 

Laboratory quality systems and related quality activities such as participation in proficiency-testing programs are being adopted increasingly. They have existed in the United Kingdom, certain other Western European nations, Canada, Australia, New Zealand, and the United States for many years. They are coming into increasing use in India and the Far East, South Africa, and Eastern Europe. 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

EPA Environmental Monitoring Systems Laboratory, Quality Assurance... 

Laboratory Accreditation and Quality Systems" Together these make laboratory managers look for added security in assuring data quality and thus invoke a desire in them to fall back on the best available standard. The result is that a CRM is often used instead of a working standard. This is a tendency that is supported and encouraged by some RM providers but discouraged by others. 

The backbone of the laboratory control system rests on the philosophy used to establish sound and appropriate specifications, standards, and test procedures to ensure drug product quality. Some of the components of this section of the law are as follows ... 

To appreciate the inputs necessary for a laboratory to conduct a quality system review. 

In large laboratories, where dozens or even hundreds of different types of analyses are carried out, an additional internal process to test the quality system is particularly important. An external assessment team can only hope to observe and assess in detail a relatively small number of the analyses during each visit, so there may be years between any one of a laboratory s externally assessed analyses being re-examined in detail. Laboratories may not have entered all of the analyses that they carry out in their scope of external accreditation. If they wish to ensure quality is maintained in these other areas of their work, an internal... 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

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