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Requirements for the Competence of Providers of Proficiency Testing Schemes

Requirements for the Competence of Providers of Proficiency Testing Schemes. ILAC Guide 13:2000 – supplementing ISO Guides 43-1 and 43-2. ILAC Guide 13:2000 Preamble. directed to the providers of PT schemes (voluntary basis),

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Requirements for the Competence of Providers of Proficiency Testing Schemes

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  1. Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC Guide 13:2000 – supplementing ISO Guides 43-1 and 43-2

  2. ILAC Guide 13:2000Preamble • directed to the providers of PT schemes (voluntary basis), • a basis for recognising the competence of providers of PT schemes by formal compliance with a set of internationally acceptable requirements for PT planning and implementation, • based on ISO Guide 43-1 and on relevant elements of ISO/IEC 17025:2000,  applicable to the characterisation, homogeneity and stablility of the PT test material, • the responsible organisation for coordinating and providing a PT scheme should ensure compentent performance (whether carried out by itself or by collaborators).

  3. ILAC Guide 13:2000Preamble • Relevant elements of ISO 9000 are included (to eliminate the need for separate recognition for compliance with ISO 9000), accordingly comprising: • Management System Requirements • Technical Requirements but: • ILAC Guide 13:2000 is applicable only for interlaboratory comparisons for the purpose of PT

  4. Management System Requirements • The provider of a PT scheme shall: • establish, implement and maintain a QM system appropriate to its scope of activities (incl. type, range, volume of PT schemes provided); • define and document policy, objectives, commitment to ensuring and maintaining the quality of all PT aspects, i.e.: • homogeneity, stability, equipment calibration, method validation, statistical procedures, performance evaluation, storage & transport, reporting ...

  5. Management System Requirements • The provider of a PT scheme shall have a Quality System covering: • aims, scope statistical design, format; • operational procedures, preparation and issuing of reports; • policies on confidential and ethical procedures, handling of complaints; • computing and information systems; • collaboration & subcontracting; • participation fees; • use of scheme results; • role and responsibilities of Technical & Quality Manager & PT coordinator.

  6. Organisation and Management • Requirements for providers of PT schemes: • managerial & technical personnel with the resources needed; • management and personnel free from commercial or other pressures; • policies and procedures to ensure the protection of confidential information and proprietary rights; • policies and procedures to avoid involvement in activities that might diminish confidence in competence, impartiality, judgement, integrity.

  7. Organisation and Management • Requirements for providers of PT schemes: • define organisation and management structure, inter-institutional relations, etc.; • specify responsibilities, authorities, have a technical management, appointed Quality & Technical Manager (deputy, if applicable)

  8. Document Control • establish and maintain procedures tocontrol all documents: • approval and issue; • unique identification; • authorised editions available where essential; • periodical document review and withdrawal of obsolete documents • review of document changes; • request, tender, contract review; • records of reviews

  9. Use of collaborators • PT provider shall have procedures for evaluating and selecting collaborators. Procurement of services and supplies • PT provider shall have procedures for the selection of services and supplies; • to use adequate services and supplies; • equipment, consumables not to be used until inspected, calibrated, verified for compliance.

  10. Control of non-conforming activities • procedures shall ensure: • designated responsibilities; • actions in case of nonconformities; • evaluation of significance; • work halted, if necessary; • remedial action; • complete records maintenance of nonconformities; • corrective actions promptly followed.

  11. Corrective actions • policies and procedures shall ensure: • appropriate personnel for implementing corrective actions; • appropriate corrective actions to eliminate causes; • document and implement any required changes to operational procedures.

  12. Corrective actions • identification of QM system problems: • client complaints, • quality control, • test material checking, • statistical evaluation, • observations / supervision, • management reviews, • internal / external audits,

  13. Corrective actions • should include: • cause analysis, • monitoring of corrective actions, • protective action to reduce the likelihood of nonconformances.

  14. Records • PT provider shall establish and maintain procedures for: • identification, collection, indexing, access, storage, maintenance, disposal, retention, quality and technical records, including: • legibility, retrievability, suitable environment for storage, prevention of damage, deterioration, loss.

  15. Technical records • PT provider shall establish and maintain a records system for: • measurent observations, • appropriate calculations, • derived data (statistical treatments, uncertainty budgets), • results from participants, • scheme reports.

  16. Internal audits • PT provider shall conduct internal audits: • with a predetermined schedule and procedure, • addressing all elements of the QM system, including the test item preparation, • at the responsibility of the technical manager to plan and organise, • by trained and qualified personnel who are independent of the activity to be audited (if ever feasible).

  17. Management reviews • Senior management shall periodically conduct a review of the PT provider‘s QM system and PT scheme procedures. • The review should take account of: • reports of management and supervisory personnel, • outcome of recent internal audits and assessments by external bodies, • feedback from participants, • other relevant factors.

  18. Technical requirements - Management, Staffing, Training • coordination and conduct of PT schemes only be undertaken if respective experience in interlaboratory comparisons and the type of test items is in place, • competence in the measurement of the properties to be determined (assignment of values, homogeneity, stability). • Note: • laboratory accreditation to ISO/IEC 17025 for appropriate tests will satisfy the requirement of competence, • if no laboratory accreditation is in place other factors should be considered (e.g. own laboratory performance in appropriate PT schemes).

  19. Technical requirements -Management, Staffing, Training • appropriate managerial personnel, • measurement of the properties of interest to be supervised by a technically competent manager, • levels of qualification for the key positions defined, • sufficient personnel with the necessary education, training, experience, • staff be sufficiently trained, • maintenance of up-to-date training records.

  20. Technical requirements - collaborators / subcontractors: • the PT provider is required: • to demonstrate that the collaborators technical competence is sufficient for the assigned tasks, • that work be placed with a competent laboratory, • that the competence of the collaborator is assessed, • that details of the methodology, results, outcomes of monitoring are available and appropriately maintained.

  21. Organisation and design - planning: • before commencement, a documented plan should be in place, including: • name and address of the PT provider, coordinator, collaborators and other personnel involved, • nature and purpose of the scheme, • procedure for selection (if applicable) and the number and identity of expected participants, • the manner in which test items are to be obtained, checked, distributed,

  22. Organisation and design - planning: • before commencement, a documented plan should be in place, including: • description of the information to be supplied to participants (pre-notification) and the time schedule for the various phases, • target dates / deadlines, • frequency / dates upon which test items are to be distributed (for ongoing schemes), • information on methods / procedures needed to perform the tests, • outline of the statistical analysis to be used, including determination of assigned values and outlier detection techniques,

  23. Organisation and design - planning: • before commencement, a documented plan should be in place, including: • a description of the data or information to be returned by the participants, • the basis of performance evaluation, • the extent to which test results / conclusions based on the outcome of the scheme are to be made public.

  24. Organisation and design - planning: • The PT provider should: • establish an advisory group of technical specialists with detailed experience in the relevant field; the responsibilities should include the complete design and arrangements of the PT scheme, • have (or have access to) a statistician to design and implement a PT scheme and analyse submitted results.

  25. Organisation and design – preparation of test items: • The PT provider should provide procedures and resources for: • material selection, • maintaining a suitable environment for preparation and testing of test material, • material preparation, measuring, testing, equipment calibration, measurement methods, • assessing material homogeneity / stability, • adequate storage facilities and conditions, • adequate packaging / labelling / transport / distribution,

  26. Organisation and design - preparation of test items • The PT provider should provide procedures and resources for: • statistical analysis of test results and assigning values of measurands / associated uncertainties, • adequate reporting service to participants.

  27. Organisation and design - homogeneity and stability testing • The PT provider shall: • use a random selection of samples to assess the homogeneity of the PT material, • have a documented assessment procedure in accordance with an acceptable statistical design (e.g. analysis of variance under repeatability conditions), • assess homogeneity after the test material has been packed, and before distribution to participants (as far as applicable), • determine PT values periodically (over a range of applicable storage conditions), • demonstrate that test material is sufficiently stable without significant changes throughout the PT scheme.

  28. Organisation and design - statistical design: • The PT provider shall: • document the statistical model and data analysis techniques to be used, • describe the reasons for the model selection,, • ensure that the statistical treatment is carried out in accordance with the prescribed procedures (i.e. ISO Guide 43-1), • give careful consideration to: trueness, precision, assigned value, confidence level, outliers, homogeneity, stability.

  29. Organisation and design - choice of method / procedure: • The PT participants shall normally be permitted to use the test method of their choice (consistent with routine procedures). • Details of the methods used should be requested from the participants, to permit comparisons and comments on the results obtained by different test methods.

  30. Conduct of PT schemes -instruction to the participants • The PT provider shall: • inform participants in due time about the intention to conduct a PT scheme, • give detailed documented instructions to all participants (influencing factors, storage conditions, test procedure, timing, etc.), • give specific instructions on recording and reporting of results (units, number of significant figures, e.g. based on dry weight or as received, etc.), • instruct participants to treat PT samples in the same manner as routine samples.

  31. Conduct of PT schemes - materials handling and storage • The PT provider / collaborator shall: • identify, preserve, segregate all test material and test items to avoid contamination, • ensure adequate packaging and secure storage, • assess conditions of stored / stocked items and materials at specified intervals during storage.

  32. Conduct of PT schemes - packaging, labelling, distribution • The PT provider shall: • control packaging and marking processes, • ensure that labels are securely attached to the packaging and remain legible and intact within the period of use.

  33. Data analysis and interpretation of PT scheme results • Appropriate data analysis and records require: • adequate data processing equipment, • a description of all data processing equipment established and maintained, • the role and responsibility of a person designated for the effective operation of the data processing system, • data processing equipment and software be validated according to documented procedures before use,

  34. Data analysis and interpretation of PT scheme results • Appropriate data analysis and records require: • received results be promptly recorded and analysed by appropriate documented statistical procedures, • documented criteria and procedures for dealing with results inappropriate for statistical evaluation, • documented criteria for determining whether test items are not suitable for evaluation (inhomogeneity, instability, contamination).

  35. Data analysis and interpretation of PT scheme results • Evaluation of performance (if required): • overall performance against prior expectation, • variation within and between laboratories, • comparison with previous schemes or published precision data, • variation between methods / procedures, • possible sources of errors, • suggestions for improving performance, • comments, recommendations, conclusions.

  36. PT scheme reports • A PT report shall be comprehensive, clear with data on the distribution of the results of all participants, including: • name and address of the provider, persons involved in the design and conduct of the scheme, • date of issue of the report, • clear identifcation of the report, • description of items, materials, details of sample preparation, homogeneity testing, • participation codes and test results, • statistical data and summaries, assigned values, acceptability ranges, graphical displays, • traceability, uncertainty of assigned values.

  37. PT scheme reports • A PT report shall include (where appropriate): • comments on particpants‘ performance by the provider and technical advisers, • details / reference to the scheme protocol, • advice on the interpretation of statistical results. • Report shall be made available to the participants within a specified time table.

  38. Communication with participants • The PT provider shall provide detailed information to potential partipants (form of scheme protocol, how to apply, scope, fees, policies). • Prompt advices in writing in the case of changes in scheme design and operation. • Feedback from particpants be encouraged for the active contribution to the development of the scheme.

  39. Confidentiality • The identity of the PT participants shall be confidential. • All information supplied by the participant to the provider shall be treated as confidential. • Note: PT schemes should be designed to ensure that there is little opportunity for collusion and falsification of results.

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