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    CookBook 20 Planning of Activities To Ensure The Validity of Test Results - 10-2018

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    Jacek Sobczyk
    The document discusses planning activities to ensure the validity of test results in accordance with accreditation standards. It recommends laboratories develop a strategy and plan that considers all validity activities, not just proficiency testing. The plan should group tests into sub-disciplines and assess risk to determine required frequency of activities. It provides examples of issues the strategy and plan should address and specifics that could be included in the plan, such as activity, test method, sub-discipline, risks, and results.

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    CookBook 20 Planning of Activities To Ensure The Validity of Test Results - 10-2018

    Uploaded by

    Jacek Sobczyk
    53 views4 pages
    The document discusses planning activities to ensure the validity of test results in accordance with accreditation standards. It recommends laboratories develop a strategy and plan that considers all validity activities, not just proficiency testing. The plan should group tests into sub-disciplines and assess risk to determine required frequency of activities. It provides examples of issues the strategy and plan should address and specifics that could be included in the plan, such as activity, test method, sub-discipline, risks, and results.

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    Eurolab Cook Book

    Original Title

    CookBook 20 Planning of Activities to Ensure the Validity of Test Results_10-2018

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    The document discusses planning activities to ensure the validity of test results in accordance with accreditation standards. It recommends laboratories develop a strategy and plan that considers all validity activities, not just proficiency testing. The plan should group tests into sub-disciplines and assess risk to determine required frequency of activities. It provides examples of issues the strategy and plan should address and specifics that could be included in the plan, such as activity, test method, sub-discipline, risks, and results.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    53 views4 pages

    CookBook 20 Planning of Activities To Ensure The Validity of Test Results - 10-2018

    Uploaded by

    Jacek Sobczyk
    The document discusses planning activities to ensure the validity of test results in accordance with accreditation standards. It recommends laboratories develop a strategy and plan that considers all validity activities, not just proficiency testing. The plan should group tests into sub-disciplines and assess risk to determine required frequency of activities. It provides examples of issues the strategy and plan should address and specifics that could be included in the plan, such as activity, test method, sub-discipline, risks, and results.

    Copyright:

    © All Rights Reserved
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    of 4

    EUROLAB “Cook Book” – Doc No.

    20

    PLANNING OF ACTIVITIES TO ENSURE THE VALIDITY OF TEST RESULTS

    INTRODUCTION

    A laboratory shall have a procedure for monitoring the validity of the results it produces. In
    ISO/IEC 17025:2017 [1] different ways of carrying out this monitoring are mentioned, such as
    the use of CRM, intralaboratory comparisons and retesting of retained test items. There are
    several other possibilities, some of them are mentioned in ISOIEC 17025:2017. The standard
    also states: “The laboratory shall monitor its performance by comparison with results of other
    laboratories, where available and appropriate”. Such monitoring shall be planned and
    reviewed and include participation in proficiency testing and/or participation in interlaboratory
    comparisons other than proficiency testing.
    There are also other documents that deal with ensuring the validity of test results, two of
    them for accredited laboratories are ILAC P9 [2] and EA-4/18 [3] which both focus on
    PT/ILCs and include requirements (it is possible that these two documents will be revised,
    but the main part will probably remain unchanged).

    In order to avoid unnecessary work, but also to save costs, it is important for laboratories to
    implement these requirements pragmatically. It is best to create a strategy and a plan for
    activities to ensure the validity of test results that address these issues in a “smart” way.

    STRATEGY

    The laboratory shall plan its activities to ensure the validity of its test results. There are
    requirements from accreditation for the participation in PTs [2, 3]. However, it is better that
    this plan/strategy encompasses all activities to ensure the validity of the results and is not
    limited to PT/ILC participation. The strategy/plan should preferably address the following
    issues:

    - The laboratory’s overall view on the validity of the test results, e.g. how the laboratory
    handles the risk associated with the laboratory’s activities,
    - How the risks of different tests should be assessed and how to minimize them,
    - The interaction between the different activities and determine in general under which
    circumstances one activity can replace another,
    - How different tests can be grouped into sub-disciplines,
    - Where relevant, justification for the different decisions of the laboratory.

    The strategy should be decided in the management review.

    PLANNING

    ISO/IEC 17025, ILAC P9 and EA/4-18 all mention the need for planning the participation in
    proficiency tests (PT). But it is better to plan all activities to ensure the validity in one
    document. The plan may have both a long perspective (one accreditation cycle) and a short
    perspective (one year). One reason is the possibility to point to activities that were or will be
    performed in a year other than the current one.

    In EA-4/18 INF:2010, the term “sub-discipline” is defined as follows:

    1
    2018
    EUROLAB “Cook Book” – Doc No. 20

    “An area of technical competence defined by a minimum of one Measurement Technique,


    Property and Product, which are related. “

    Laboratories are required to identify ”groups of sets of measurement techniques, properties


    and products on which the outcome of a PT for one of these sets can be directly correlated to
    the other sets of measurement techniques, properties and products contained within the
    group. These groups of sets of measurement techniques, properties and products are
    termed a sub-discipline.”

    An activity to validate one test method is valid for the whole sub-discipline, this is not only
    valid for PTs. Examples of sub-disciplines are tensile testing of metallic materials or fire
    testing construction elements in furnaces.

    The risks associated with different tests may be mentioned in the plan as justification for the
    participation frequency. In areas of low risks, the frequency of activities in terms of validity
    may be lower than in areas where the use of the test results involves high risk. Previous
    results of validity activities may also serve as a justification for the frequency of participation,
    especially if the risk has decreased. The risk may be affected, for example, by:

    - the number of tests/calibrations/measurements,


    - the turnover of technical staff,
    - experience and knowledge of technical staff,
    - the sources of traceability (e.g., availability of reference materials, national standards,
    etc.),
    - the significance and final use of the test/calibration data (e.g., forensic science is an
    area requiring a high level of assurance).

    Specifically, the plan could include at least the following:

    - the activity, such as participation in proficiency tests (PT), comparison with computer
    calculation etc.,
    - the test method, such as European method for tensile testing of steel (if the activity is
    planned well in advance) and EN ISO 5178:2011 Destructive tests on welds in
    metallic materials – Longitudinal tensile test on weld metal in fusion welded joints
    (ISO 5178:2001) (if the activity is lined up next),
    - the sub-discipline to which the activity belongs, e.g. Tensile testing of metals,
    - the risk associated with the sub-discipline,
    - the date of activity. The closer the date is, the more detailed information is needed,
    e.g. if the activity is planned several years in advance, often the year or the quarter
    are sufficient,
    - previous activities or other activities performed in the context of the sub-discipline and
    the result, in particular successful participation,
    - the result of the activity, after it has been performed.

    When an activity is performed to ensure the validity of the laboratory’s test results, it shall be
    documented, and the results shall be analysed. A decision on whether urgent measures are
    required will be taken after the analyses. If no immediate action is needed, the results of
    several activities can be analysed in a group to identify trends etc. The result of these
    activities shall be discussed in the management review.

    2
    2018
    EUROLAB “Cook Book” – Doc No. 20

    When the accreditation body carries out an on-site surveillance visit the laboratory shall
    justify the frequency of participation. Arguments in this discussion can be:

    - good performance in previous activities,


    - low risk when using the test results,
    - activities performed on using other similar methods,
    - other activities performed, justifying non-participation in proficiency tests.

    In any case, it should be recognised, however, that the activities to ensure the validity of the
    test results are carried out primarily not for the accreditation body, but for the customers of
    the laboratory and the laboratory itself.

    References

    [1] ISO/IEC 17025:2017 General requirements for the competence of testing and calibration
    laboratories
    [2] ILAC P9:06/2014 – ILAC Policy for Participation in Proficiency Testing Activities
    [3] EA-4/18 INF:2010 Guidance on the level and frequency of proficiency testing participation

    3
    2018
    EUROLAB “Cook Book” – Doc No. 20

    Annex 1: Exemplary plan

    Note that the same activities may appear in both plans

    Example of a plan (short term)

    Date Activity Method Sub- Risks Previous Result of Comment


    discipline result of the activity
    this
    activity
    or other
    activities
    2018-10- Proficiency SS-EN ISO Tensile Medium No
    10/20 Test (PT) 5178:2011 test of risks previous
    Destructive metals (see risk results
    tests on welds analysis) available
    in metallic
    materials –
    Longitudinal
    tensile test on
    weld metal in
    fusion welded
    joints

    Example of a plan (long term)

    Date Activity Method Sub- Risks Previous Result of Comment


    discipline result of the activity
    this
    activity
    or other
    activities
    2018 Q3 Interlaboratory Not yet Tensile Medium
    Comparison decided test of risk (see
    (ILC) metallic risk
    analysis)

    4
    2018

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