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ILC_PT.ppt

  1. INTER-LAB COMPARISON / PROFICIENCY TESTING AND ESTIMATION OF SCORES
  2. Measurements by labs  Trillions of measurements daily worldwide  Aspects of measurement  Quality  Repeatability and reproducibility  Consistency  Customer’s specification  And many more
  3. Measurement Results  Lab A measurement results  x  x + µ  x - µ …..  Results are consistent, repeatable & reproducible  Lab B measurement results  y  y + ∂  y - ∂ …..  Results are consistent, repeatable & reproducible  Although the results of the same sample, the results of Lab A or Lab B may or may not be consistent with each other, even if measured by same operator in the lab.  The results of Lab A or Lab B may or may not be consistent with each other, if measured by different operators in the lab.  More so, the results of Lab A or Lab B may or may not be consistent with each other when compared with each other.
  4. Why ILC/ PT ? © Anuj Bhatnagar 4  First: To ensure that a single operator / analyst within a laboratory is able to consistently reproduce the same result on the same sample.  Second: The result produced by this operator/ analyst should reflect the result that would have come from any other analyst in the laboratory.  Third: Any results from the laboratory as a whole should reflect the results that are agreed upon by many other laboratories.
  5. Inter-Lab Comparison /Proficiency Testing  It is one of the techniques by which the data produced by a lab/ method/ software/ procedure is validated.  It is means of quality control for objectively assessing the quality control procedures of a lab.  Objective means of assessing the reliability of data they are producing.  It is method to check a lab’s testing / calibration performance.  Performance within its own lab and with other labs.  Provide additional confidence to the lab’s customers.  It is pre Accreditation activity.
  6. Users of ILC/ PT  Participant laboratories, Accreditation bodies,  Regulatory authorities,  Clients of the labs  Self evaluation of labs  Values to CRMs  ILAC/ APLAC/ EA MRA partners  Standards Bodies
  7. PT provider/ Coordinator Accreditation Bodies Professional Bodies ILAC/ APLAC MRA Partners Laboratories Ref. Material Producers Indirect Customers (Regulators) Direct Customers (Users) Users of ILC/ PT
  8. ILAC Policy (ILAC P-9) “Accreditation bodies seeking to sign or seeking to maintain the status as signatory to the ILAC MRA need to demonstrate the technical competence of their accredited calibration and testing laboratories. One of the elements by which accredited calibration and testing laboratories demonstrate technical competence is by satisfactory participation in PT activities where such activities are available”.  Recommended minimum appropriate PT activities per laboratory is:- one activity prior to gaining accreditation - one activity relating to each major sub discipline of a labs scope of accreditation with in four years.
  9. Inter-Lab Comparisons Widely used for a number of purposes Typical purposes for inter-laboratory comparisons include: 1. Evaluation of the performance of laboratories for specific tests or measurements and monitoring laboratories' continuing performance; 2. Identification of problems in laboratories and initiation of actions for improvement which, for example, may be related to inadequate test or measurement procedures, effectiveness of staff training and supervision, or calibration of equipment; 3. Establishment of the effectiveness and comparability of test or measurement methods; 4. Provision of additional confidence to laboratory customers;
  10. 5. Identification of inter-laboratory differences; 6. Education of participating laboratories based on the outcomes of such comparisons; 7. Validation of uncertainty claims; 8. Evaluation of the performance characteristics of a method – often described as collaborative trials; 9. Assignment of values to reference materials and assessment of their suitability for use in specific test or measurement procedures; and 10. Support for statements of the equivalence of measurements of National Metrology Institutes through “key comparisons” and supplementary comparisons conducted on behalf of the International Bureau of Weights and Measurement (BIPM) and associated regional metrology organizations. Inter-Lab Comparisons
  11. Proficiency Testing Proficiency testing involves the use of inter-laboratory comparisons for the determination of performance of the laboratory and that of its testing personnel/ analysts/ operators, as listed in 1) to 7) above. Proficiency testing does not usually address 8), 9) and 10) because laboratory competence is assumed in these applications, but these applications can be used to provide independent demonstrations of laboratory competence. However, the requirements of International Standard ISO 17043 can be applied to many of the technical planning and operational activities for 8), 9) and 10).
  12. Proficiency Testing © Anuj Bhatnagar 12  The precise way is not prescribed in ISO/IEC 17025, although it refers to the use of proficiency testing at couple of places.  The process is clearly defined/ explained in detail in some other international standards  International Standards used for this purpose:  ISO 17043  Guides made by various Accreditation Bodies available on internet
  13. Clause 5.4.5 of ISO/IEC 17025 © Anuj Bhatnagar 13 (Cl 5.4.5.2): Lab Should Validate….  Non-standard methods,  Lab designed/developed methods,  Standard methods used outside of their intended scope,  Amplification and modification of standard methods,  Procedure for sampling, handling and transportation.
  14. © Anuj Bhatnagar 14 By use of:  Calibration using Ref standards or Ref material  Comparison of results achieved with other methods  Inter-laboratory comparison or Proficiency Testing  Systematic assessment of factors influencing result  Assessment of the uncertainty of results based on scientific understanding of the theoretical principles and practical experience.
  15. Clause 5.9 of ISO/IEC 17025 © Anuj Bhatnagar 15  Assuring the Quality of Test and Calibration results: …. This monitoring shall be planned and may include, but not limited to: (b) participation in interlaboratory comparison or proficiency-testing programmes
  16. ISO/IEC 17043 © Anuj Bhatnagar 16 ISO/IEC 17043 is the new international standard to determine the competence of organizations that provide proficiency testing. ISO/IEC 17043 is published in 2010 Replaces ISO/IEC Guide 43-1 and 43-2, but preserves and updates the principles for the operation of proficiency testing described in ISO/IEC Guides.
  17. © Anuj Bhatnagar 17  …directed to the providers of proficiency testing schemes who wish, on a voluntary basis, to demonstrate their competence, for the purpose of accreditation or other recognition…  …. Only to the use of inter-laboratory comparisons for the purpose of proficiency testing…
  18. Till date, we had © Anuj Bhatnagar 18  ISO/IEC Guide 43-1 Proficiency Testing by Inter-laboratory Comparisons. Part 1: Development and operation of proficiency testing schemes International Organization for Standardization Geneva, First Edition 1997  ILAC- G13 Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes ILAC Technical Accreditation Issues Committee, 2007 (latest revised issue)
  19. Actual work on standardization for accreditation of proficiency test providers is mainly focused on these two documents © Anuj Bhatnagar 19 ISO /IEC Guide 43-1 ILAC – G13 ISO/IEC 17043
  20. ISO/IEC 17043 © Anuj Bhatnagar 20  Content Structure: 1. Scope 2. References 3. Terms and Conditions 4. Technical requirements 5. Management Requirements 6. Appendix Unlike ISO/IEC 17025, technical requirements get priority over management requirements in ISO/IEC 17043.
  21. ISO/IEC 17043 © Anuj Bhatnagar 21  New Topics and additions: 4. Technical Requirements 4.4.5 Assigned Values 4.7 Data analysis and interpretation of proficiency testing scheme results Annex A: Types of proficiency testing schemes Annex C: Selection and use of proficiency testing schemes
  22. Other documents useful in PT © Anuj Bhatnagar 22  Eurachem Guide : 2010 (for PTs in food sector) Selection, use and interpretation of proficiency testing (PT) by laboratories  Eurachem Guide (2011) on Selection, Use and Interpretation of Proficiency Testing (PT) Schemes For methods for evaluation of proficiency testing  ISO 13528  Statistical methods for use in proficiency testing by inter-laboratory comparisons  ISO 5725: 1 to 6  Accuracy (trueness and precision) of measurement methods
  23. Terms and Definitions © Anuj Bhatnagar 23  Assigned value: value attributed to a particular quantity and accepted, sometimes by convention, as having and uncertainty appropriate for a given purpose  Accepted reference value: a value that serves as an agreed upon reference for comparison and which is derived as (i) a theoretical or established value, based on scientific principles, (ii) an assigned value, based on experimental work of some national or international organization, and (iii) a consensus value, based on collaborative experimental work under the auspices of a scientific or engineering group.
  24. Accuracy and precision The dictionary definition of both ‘accuracy’ and ‘precision’ are roughly the same, indicating that these words may be used synonymously. However in ‘Analytical Science’ they have two separate meanings, the difference between them is best illustrated by using target diagrams Poor precision poor accuracy Good precision poor accuracy Good mean accuracy poor precision Good accuracy good precision
  25. Accuracy and precision (2) You saw from the previous slide, a set of results can be either accurate and/or precise or can be neither accurate nor precise. Thus accuracy may be defined as: The closeness of the mean value from a replicate set of results to the true or accepted value Precision may be defined as: The spread of results from a replicate set of measurements
  26. © Anuj Bhatnagar 26  Reference laboratory: laboratory that provides reference values on a test item.  Reference material (RM): Material or substance, one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of measurement method, or for assigning values to the materials.
  27. © Anuj Bhatnagar 27  Certified reference material: reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.  Laboratory Bias: The difference between the population mean of the test result and an reference value.
  28. © Anuj Bhatnagar 28  Inter-laboratory comparisons: organizations of performance and evaluation of tests on the same or similar test items by two or more laboratories in accordance with predetermined conditions.  Coordinator: organization (or person) with responsibility for coordinating all of the activities involved in the operation of a proficiency testing scheme.  Customer: organization or individual for which a proficiency scheme is provided through a contractual arrangement.
  29. © Anuj Bhatnagar 29  Participant: laboratory, organization or individual that receives proficiency test items and submits results for review by the proficiency test provider  Proficiency testing: evaluation of participant’s performance against pre established criteria by means of interlaboratory comparisons.  Proficiency test item: sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing
  30. © Anuj Bhatnagar 30  Proficiency testing provider: organization which takes responsibility for all tasks in the development and operation of proficiency testing scheme.  Proficiency testing round: single complete sequence of distribution of proficiency test items, and the evaluation and reporting of results to the participants  Proficiency testing scheme: proficiency testing designed and operated in one or more rounds of a specified area of testing, measurement, calibration or inspection
  31. © Anuj Bhatnagar 31  Outlier: member of a set of values which is inconsistent with the other members of that set.  Extreme results: outliers and other values which are grossly inconsistent with other members of the data set.  Robust statistical techniques: techniques to minimize the influence that extreme results can have on estimates of the mean and standard deviation.  Variance: A measure of dispersion, which is the sum of the squared deviations of observations from their average divided by one less that the number of observations.
  32. © Anuj Bhatnagar 32  Standard deviations: The positive square root of the variance.  Subcontractor: organization or individual engaged by the proficiency test provider to perform activities (on behalf of the provider) that effect the quality of proficiency testing scheme.  Uncertainty of measurement: parameter associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.
  33. © Anuj Bhatnagar 33  Random error: result of a measurement minus the mean that would result from an infinite number measurements of the same measurand carried out under repeatability conditions. Random error is equal to error minus systematic error. It is possible to determine only an estimate of random error as only a finite number of measurements can be made.  Systematic error: Mean that would result from an infinite number of measurements of the same measurand carried out under repeatability conditions minus a true value of the measurand. Systematic error is equal to error minus random error. Systematic error and its causes cannot be completely known.
  34. © Anuj Bhatnagar 34  Repeatability: closeness of agreement between the results of successive measurements of the same measurand carried out under repeatability conditions. The repeatability conditions are: - the same measurement procedure - the same observer - the same measuring instrument, used under same conditions - the same location - repetition over a short period of time.
  35. © Anuj Bhatnagar 35  Reproducibility: Closeness of agreement between the results of the measurements of the same measurand carried out under changed conditions of measurement. A valid statement of reproducibility requires specification of the conditions changed. A changed condition include: - principle of measurement - method of measurement - observer - measuring instrument - reference standard - location - conditions of use - time
  36.  Metrological Traceability The property of a measurement whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. © Anuj Bhatnagar 36
  37. Case 1 One of the labs (Accredited lab) is testing PVC insulated cables as per IS 694:1990. In the Insulation Resistance test (IR), a sample of 3 m is kept immersed in water and IR is calculated. The lab had been doing this test for quite some time. When the lab participated in the PT program for cable test, its score was unsatisfactory in this particular test. On examining it was observed that the lab was taking only 3m and immersing it in water with both ends (app.10cm) kept out of water. Effective immersion is then about 2.8 m and not 3 m as required. PT test in this case helped the lab in finding out this discrepancy.
  38. Case 2 In the PT test conducted by an Accredited Lab for testing of electric Irons as per IS 366, one of the participating lab reported very high values for the temperature rise of the knob. This lab had an unsatisfactory score and on examination, it was observed that the temperature rise of the knob was being taken by this lab after removal of the knob, which is actually not permitted. The lab was informed about this and later it modified its procedures for conducting this test.
  39. Case 3 One of the oil company in the public sector was using a method of testing Lube Oil (determining impurities of Lube Oil) which was actually developed by Shell. The oil company wished to use this method after making some modifications in the original method developed by Shell, owing to the different ambient conditions prevailing in India. The company made the modifications in the original procedure and used inter-lab comparison program involving 20 labs for validating this procedure. The method / procedure was validated using PT techniques and now the company is using this procedure for their purpose. It has also obtained NABL accreditation for their labs in India and this method.
  40. Case 4 One of the accredited laboratory participated in PT organized by APLAC and received a sample of small transformed. The lab tested the transformer for certain tests. When the report was received, it came out that the lab’s result was unsatisfactory (i.e. more than 3). It was required to take corrective action and inform the country’s Accreditation Body. It did so but the corrective action was not found to be very effective by APLAC. This resulting in the accreditation of the lab withdrawn by the Accreditation body.
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