Requirements for the Competence of Providers of Proficiency Testing Schemes - PowerPoint PPT Presentation

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Requirements for the Competence of Providers of Proficiency Testing Schemes

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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 ... – PowerPoint PPT presentation

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Title: Requirements for the Competence of Providers of Proficiency Testing Schemes


1
Requirements for the Competence of Providers of
Proficiency Testing Schemes
  • ILAC Guide 132000
  • supplementing ISO Guides 43-1 and 43-2

2
ILAC Guide 132000Preamble
  • 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 170252000, ? 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 132000Preamble
  • 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 132000 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 to control 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 providers 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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