Thanks to SHAPYPRO team, you can check your technical competence if your lab working in biocidal efficacy testing area.
VALIDATION TEST
Validation of a test method implies that its basic characteristics (bias, precision, linearity, etc.) have been evaluated under different conditions.
Fitness-for-purpose implies that the quality of the measurement performed is adequate so that, taking into account the needs of each sector, correct decisions can be made based on the test results. In other words, fitness-for-purpose does not necessarily represent the best quality that the test methods can give, as this approach could involve unnecessary expense in carrying out the tests. unnecessary expense in performing the measurements (e.g. with too small a bias and precision, which may not be useful). small bias and precision, which may not be of practical use).
ASSESSMENT COMPLIANCE
The assessment of compliance with the requirements set out in the method validation requires the use of different tools, such as use of different tools, such as: participation in intercomparison testing, regular use of reference materials or the regular use of reference materials or implementation of other internal quality control tools, which serve to assess different aspects of the method validation. tools, which are used to evaluate different aspects of the test process (from receipt of the item to reporting). to reporting).
On the other hand, the routine implementation of external control through proficiency testing allows checking that the factors determining the magnitude of the uncertainty have not changed since the validation process demonstrated the adequacy of the method. Thus, laboratories that do not have an external reference can work for long periods with significant biases without being aware of this problem.
Therefore, intercomparisons are an appropriate means to ensure that intra-laboratory activities (validation, use of reference materials and quality control) are working satisfactorily and, if unexpected sources of error are detected, to initiate corrective actions.
Regular participation in intercomparison testing also allows comparison of results. In addition, SHAPYPRO offers personalised advice after the competence assessment and helps to implement satisfactory mitigation measures.
Intercomparisons can cover different objectives, such as:
- evaluation of the performance of laboratories.
- identification of problems in laboratories
- Establishment of efficiency and comparability of tests or measurement methods.
- identification of differences between laboratories
- characterisation of methods
- education of technical staff
FRECUENCY OF PARTICIPATION
Laboratory shall establish a frequency of participation taking into account at least the following aspects at least the following aspects:
- Complexity of the method: in cases where the test involves a long process, complex and with a large number of intermediate steps before the final result is issued, a higher frequency of participation should be considered. In such cases, a higher frequency of participation should be considered, as these are usually the cases, subject to a higher probability of error.
- Variability in the type of matrices or the possibility of interferences that are difficult to control in validation.
- Volume of activity: it should be avoided to consider that the infrequent performance of a given test may be associated with a low/low frequency of participation, as there may be situations where greater participation is necessary in order to assess the maintenance of requirements established in the validation.
- History of intercomparisons: in those cases where the laboratory has previous participations, the results obtained should be taken into account in order to establish an appropriate frequency.
Our programs cover the full scope of the biocidal efficacy standards within 5 years, as stated in ISO/IEC 17025.
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