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Technical requirements  Sampling  Analysis  Reporting of the results.

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Presentation on theme: "Technical requirements  Sampling  Analysis  Reporting of the results."— Presentation transcript:

1 Technical requirements  Sampling  Analysis  Reporting of the results

2  Selecting analytical procedures suitable for answering the analytical questions (good science)  Performing the selected tests in a traceable manner, according to clear and transparent procedures under proper conditions (good QA system) Quality

3 The Laboratory Process Laboratory Report Sample

4 Intermezzo  Participant discussion on critical aspects after receipt of the sample, prior to analysis Sample

5 The Laboratory Process: Sampling Registration Labelling Identification Storage Temperature control Receipt Disposal Protection

6 Sampling ( ISO 17025:2005, 5.7, 5.8 ) Sampling plan and procedures:  Statistically based appropriate  Deviations required by customer are recorded and reported  Recording data as sampling procedure, identification of sampler, sampling location, statistics as appropriate  Abnormalities of samples are recorded  Secure storage -> further investigations or return to service

7 Laboratory Process Laboratory  Participant discussion the analytical process Sample


9 Analyzing the laboratory Equipment Reference standards Quality Control Uncertainty of measurement Calibration Method validation SOP Traceability

10 Equipment - 1 (ISO 17025:2005, 5.5)  Identification  Maintenance plan  Calibration according to plan and use  Records are maintained from checks, calibration, maintenance, defects


12 Equipment - 2 (ISO 17025:2005, 5.5)  Adequate equipment is required for the correct performance of tests, meets specifications (IQ, PQ, OQ)  Equipment is operated by authorized personnel  Up-to-date instructions are present for use and maintenance

13 Equipment - 3 (ISO 17025:2005, 5.5)  Equipment out of laboratory or calibrated is tested first for correct functioning before returning to service  Calibration state is controlled and if verification checks of calibration are needed they are carried out

14 Equipment - 4 (ISO 17025:2005, 5.5)  Handling of defect equipment  If calibration results in correction factors procedures are available to ensure that copies (computer software) are correctly updated  Safeguarding from adjustments (hardware and software) which invalidates results

15 Test and calibration methods and method validation -1 (ISO 17025:2005, 5.4)  Use of appropriate methods within its scope (handling samples and estimation measerements uncertainty)  Preferably use of methods published in international, regional or national standards  Appropriate method is chosen/advised by laboratory

16 Test and calibration methods, method validation - 2 (ISO17025:2005, 5.4)  Laboratory–developed methods are planned activities and assigned to qualified personel with adequate resources  Plans are updated and communicated as development proceeds  Validation of non-standard methods is required

17 Test and calibration methods, method validation – 3 (ISO17025:2005, 5.4)  Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled  Validation is required for non-standard methods, standard method used outside their scope or modified methods

18 Test and calibration methods, method validation - 4 (ISO17025:2005, 5.4)  Validation items:  Uncertainty of results, detection limit, selectivity, linearity, limit of repeatability, reproducibility, robustness against external influences, interference from the matrix of the sample object  Validation shall be relevant for the customer needs

19 Test and calibration methods, method validation – 5 (ISO17025:2005, 5.4)  A procedure has to be applied to estimate the uncertainty of measurements for calibrations: reference is Guide to the Expression of Uncertainty of Measurement  Use knowledge and experimental data (validation,quality controls, profiency tests)

20 Assuring the quality of test/calibration results (ISO 17025:2005, 5.10) Resulting data are recorded and trend analysis (if practicable by statistics) carried out:  regular use of reference materials/and or internal quality control  Interlaboratory comparison (profiency tests)  Replicate tests using the same or different methods  Retesting of retained items  Correlation of results for different characteristics of an item  Planned action is undertaken when data are OOS, correction of problem and prevention being reported

21 Uncertainty of measurement Random effects:  Short term fluctuations, temperature, pressure, humidity  Variability of measurer Systematic effects:  Offset measuring instrument  Drift between calibrations  Personal bias reading analogue scale  Uncertainty value reference standard

22 Intermezzo  Participant discussion  Closing the books, critical points for reporting data Report Laboratory Sample

23 The Laboratory Process Certificate

24 Reporting results -1 (ISO 17025:2005, 5.10)  The laboratory has to report all requested information to the customer  Results are reported with complete information about laboratory, customer, sample data, used method, authorizing personnel  A simplified report is allowed for internal customers or if agreed with the customer

25 Reporting results - 2 (ISO 17025:2005, 5.10)  Where necessary for interpretation of results deviations are given  Where relevant compliance or non- compliance statement is given  If applicable estimated uncertainty of measurement  Identification of results from subcontractors

26 Reporting results - 3 (ISO 17025:2005, 5.10)  Electronical transmission of results is allowed  Opinions and interpretations are out of accreditation, clearly marked and the basis has to be documented  Admendments are marked as supplement to original test report, or if a new report is necessary shall refer to the original report

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