Assurance of an adequate handling of test items in the laboratory in charge of the tritium analyses in Havana, Cuba

Full text: One of the technical requirements of the ISO/IEC 17025 is the handling of test items. For this reason the laboratories whose design of Quality Management System (QMS) is based on this norm, should guarantee the satisfaction of this requirement. The QMS of the Environmental Radiological Surveillance Laboratory, belonging to the Center for Radiation Protection and Hygiene at Havana, Cuba, have implemented, among many other aspects, those related with the guarantee of traceability of its test items, since its reception in the Laboratory until the issue of the reporting the results. In a general way, in the Quality Manual of the Laboratory is declared how this requirement is complied, and reference is made to the procedures, from the Laboratory and from the institution, that regulate the actions to carry out in this sense. With the objective of guaranteeing the unequivocal pursuit of the samples that receive the Laboratory, they are coded according to the 'Procedure for the reception and storage of samples' (PR/LVRA/01). The responsible for the storage of the samples in the Laboratory is the person in charge of executing this operation. To guarantee the pursuit of the time in that the assays are executed and in attention to the customer's possible complaints, the Laboratory established an official model of services request, annexed to the PR/LVRA/01. This service request accompanies to each sample that Laboratory receives and is kept in the Record of service requests (RNP/LVRA/05). All samples that Laboratory receives undergoes inspection to determine whether it meets the established requirements for their later assay, so any nonconformity with the requirements to the samples, that conspires against the quality, can be detected. In the PR/LVRA/01 the necessary steps for the inspection and the storage of samples that the Laboratory receives and the elements of process control are described. This procedure applies to all the test items. The responsible for the storage of samples in the Laboratory is in charge of executing this procedure, informing to the quality manager about any found anomaly so that can be taken the corresponding correctives actions. All nonconformity and correctives actions are written in the Record of nonconformity of the Laboratory (RNP/LVRA/12). In the Quality Manual of the Laboratory is declared that the laboratory witness samples will be handled according to that exposed in the PR/LVRA/01 and that it is necessary to guarantee appropriate storage conditions for these samples, according to the requirements of assay. In this case, it is also the responsible for the storage of the samples in the Laboratory the person in charge of fulfilling these functions. In the General Procedure of the Laboratory (PR/LVRA/02) the whole journey of the samples in the Laboratory for its assay, as well as the accompanying records and the quality controls to carry out in each step of the process, is described. At last, the standardized model in the laboratory for report the results establishes that the same entrance identification code of samples should appear. In the same way, in the Record of samples (RNP/LVRA/01) appear the code of the report the result, corresponding to the assay that is carried out to each sample. The established process diagrams at Laboratory in order to guarantee an adequate handling of test items are exposed in a detailed way in this work. (author)