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Staff training, laboratory quality

For all quality standards, staff working in a laboratory must be suitably trained. For laboratory workers a training record is a document used to record each analyst s training and the date when the analyst is deemed competent to... [Pg.63]

In addition to the mass spectral aspects of these assays, which are outlined below, there may also be extensive requirements to be met by the analyst with respect to compliance with good laboratory practice, which governs the operations of analytical laboratories and includes sampling regimes, assay validation procedures (e.g., limits of detection, limits of quantification, accuracy, reproducibility, and ruggedness), and laboratory accreditation (e.g., staff training, laboratory equipment, documentation, quality assurance, and quality control).142-145... [Pg.367]

Many tools are in the hands of the analyst and management to adapt the laboratory to his task. Figure 1.3 shows that they are of various types. They have to be included in the entire management of the laboratory, e.g. training of staff and motivation must be planned and built in the lifestyle and the lifetime of the laboratory. Quality always pays or as W. Edwards Deming preached cheaper is not always better, better is always cheaper . It may appear to be expensive and time consuming, but it is the only way to cope with unexpected situations, e.g. absence of staff, sudden unexpected workload etc. It is out of the scope of this book to discuss all infrastructure and management aspects necessary to set up a quality system within a laboratory. [Pg.4]

Quality assurance (QA) refers to the planned and systematic actions and measures that the laboratory uses to ensure the quality of its operations. These measures include, amongst others, implementation of a quality system, a suitable infrastructure and laboratory environment, appropriately trained and skilled staff, calibrated and well-maintained equipment, quality control procedures. [Pg.327]

Like the chef the laboratory manager has many constraints in moving forward he cannot merely add staff and cost to the kitchen, he cannot begin to deliver inconsistent product, his responsiveness may not decrease, he cannot achieve quality without well qualified, well trained staff. Instead, he must identify real efficiencies that can be derived from scale. [Pg.13]

The responsibilities for suitable validated analytical methods, however, do not rest solely in the analytical method development group. Today the analytical function uses new and sophisticated chromatographic and other instrumental techniques that require a high level of technical expertise. It is the responsibility of quality control management to ensure that its staff is adequately trained and its laboratories properly equipped so that new analytical methods can be properly transferred from an analytical methods group to the quality control department. A mutual understanding of each other s responsibilities and limitations is... [Pg.204]

It is now internationally recognized that for any laboratory to produce reliable data, an appropriate scheme of QA must be implemented. As a minimum, this must ensure that the laboratory is using methods that have been validated as fit for the purpose before their application to a specific task. These methods should be fully documented, staff should be trained, the laboratory infrastructure should be appropriate to the measurements to be made, and mechanisms ensuring that the procedure is under statistical control should be present. Implementation of appropriate QC measures ensures that the data produced and reported are of known quality and uncertainty. Last but not least, the laboratory should participate in PT schemes in order to demonstrate its competence.6... [Pg.391]

A QA system describes the overall measures that a laboratory uses to ensure the quality of its operation. Typical items include suitable equipment, trained and skilled staff, documented and validated methods, calibration requirements, standards and RMs, traceability, internal QC, PT, nonconformance management, internal audits, and statistical analysis. [Pg.392]

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. [Pg.159]

Academies of Federated Republics. Most of the federated republics of the Soviet Union have their own Academies of Sciences which, for the sake of convenience, will be referred to as republic academies. A republic academy usually starts out as a branch of the Akademiya Nauk SSSR. Its first task is to train research personnel from among the respective nationalities to staff the laboratories and institutes. As qualified personnel becomes available, it gradually takes over administrative and research duties. When the local staff is of such quality and quantity that it can initiate and carry out a research program on a proper level, and when its training program is developed to a point where it is assured of a continuous supply of scientific personnel, the branch is transformed into an independent academy. [Pg.147]

The main point about accreditation is that the laboratory must be able to satisfy an independent outside official body that the work it does is consistently of a quality appropriate for the purpose intended. So, a laboratory that is accredited for some or all of its work, is subject to regular inspections by the accreditation agency. The laboratory has to keep extensive documentation to show that all the requirements of the specifications for accreditation are met on a continuous basis. For example, it has to keep up to date evidence of staff competence and training, performance of equipment and the test results for reference samples (see the UKAS website http Iwww.ukas.com). [Pg.73]

Unfortunately, the GCP guidelines are not always applied to other biomedical research and rarely to independent studies on marketed products initiated by clinicians without support from the manufacturer. There is still a double standard in therapeutic research and therefore in published papers arising from them. Editors and reviewers do not see the full documentation of non-sponsored biomedical research, whereas the regulatory authorities and their expert advisers will expect to see all data in the support of new medicines. The extent of the differences in standards is recognised when a potential investigating site is visited and one realises that there are no SOPs, that documentation of laboratory procedures is suboptimal and that staff are not properly trained. These facets are mentioned because the training that clinicians, scientists and technicians receive from company-based staff before and during a sponsored clinical trial adds considerably to the quality standards. [Pg.347]

At present there is no universally accepted Standard Method for Preparation of Samples from Contaminated Sites and few laboratories operate strictly comparable sample preparation methods. So it is important that the methods used for initial sample preparation are verifiably/// for their analytical purpose and applied by trained staff under an appropriate level of quality control. The design of sample preparation methods is generally constrained by the need to produce powders or finished samples with uniform physical characteristics by the most rapid method, whilst preventing the loss or alteration of any part of the sample by contamination, cross-contamination or chemical reaction. [Pg.59]

Each country has its own accreditation body for laboratories. In the United States, NIST is administering the National Voluntary Laboratory Accreditation Program (NVLAP) [109]. The criteria for accreditation used by NVLAP is consistent with ISO Guide 25, which involves the following items (1) quality system, (2) staff competence and training, (3) facilities and equipment, (4) calibration and traceability, (5) test methods and procedures, (6) recordkeeping, and (7) test reports. [Pg.1215]

In order to achieve reliable results, Quality Control laboratories should have sufficient resources and appropriate facilities, with properly trained, managed and motivated staff, and adopt good quality control laboratory practices. Materials and products should not be released for use or supply until their quality has been judged satisfactory. Quality Control should be independent from Production. Quality Control should adopt procedures necessary to ensure that the relevant tests and checks are carried out... [Pg.607]

All Production, Quality Control and Laboratory personnel and all other personnel (e.g. maintenance, service and cleaning staff) whose duties take them into manufacturing areas, or which bear upon manufacturing activities, should be trained in the principles of Good Manufacturing Practice and in the practice (and the relevant theory) of the tasks assigned to them. [Pg.674]

The concept of total quality management (TQM) recognizes the importance of the contributions of all departments and individuals to the quality of the service provided and supports and cultivates a one team approach. In order to optimize the quality of outputs, staff must be adequately trained, involved in their tasks in such a way that they can contribute their skills and ideas, and must be provided with the necessary resources to do their job effectively and efficiently. All employees, from top management to technicians and support staff, must know the mission of the laboratory, including the role they play and their specific tasks, and must work in harmony with each other and with the laboratory s clients to achieve the organizational objectives. [Pg.329]

Assurance of competent staff begins by preparing position descriptions that specify the educational requirements, operational experience, and duties of the laboratory personnel. The qualifications of the supervisors, analysts, and instrument operators who are hired must match these descriptions. Each staff position should have a set of core training specifications (e.g., radiation safety, chemical safety, waste minimization and disposal, quality assurance) plus specific training in its area of responsibility. Table 13.3 provides suggested position titles, educational requirements, and general responsibilities for the optimal laboratory staff. [Pg.279]


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See also in sourсe #XX -- [ Pg.181 ]




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