AIHA-LAP, LLC Webinar

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AIHA-LAP, LLC Webinar

• Measurement Uncertainty and
• Traceability Policies Review
• Friday, April 30, 2010

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Webinar Outline

• Introduction of Presenters/Moderators
• Ground Rules
• Background
• Whats New
• Basis of the new Policies
• Policy Review - Section by Section
• Discussion of guidance and examples
• What to Expect Beginning April 1
• Questions and Answers

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Webinar Speakers

• Speakers
• Margie Breida
• Ronald Peters (MU)
• Maureen Hamilton (Traceability)
• Moderator
• Sage Morgante

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Ground Rules

• All phone lines will be muted during the
  presentation.
• Speakers will present information in the slides.
• Questions can be be typed in the chat box during
  the presentation. Participants should type in
  their name/laboratory and a question.
• When the speaker thinks it is appropriate to take
  questions, he/she will pause and the moderator
  will read the questions.
• We will answer as many questions as we can, but
  not all questions will be answered.

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Ground Rules (contd)

• If you experience technical problems or you
  cannot connect to the call, please contact us at
  [phone].

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Background

• AIHA-LAP, LLC evaluation for international
  recognition (APLAC/IAAC)
• MU and traceability changes needed so that we are
  more aligned with other accreditation bodies
• New policies, guidance and examples replace
  previous guidance.
• New MU and traceability documents posted on web
  site on February 18, 2010.
• Became effective April 1, 2010.
• All assessments are now being conducted against
  these new policies.

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Whats New?

• Follow links to the 2010 AIHA-LAP, LLC Policy
  Modules
• Appendix G
• Policy on the Estimation of Uncertainty of
  Measurement (Rev. 0, effect. April 1, 2010) 
• Guidance on the Estimation of Uncertainty of
  Measurement (Rev. 1, 2/17/10)
• Guidance on Statistical Analysis of EMLAP QC 
  (Rev. 1, 2/17/10)

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Whats New?

• Appendix H
• Policy on Traceability of  Measurement (Rev. 0,
  effect. April 1, 2010)
• Guidance on Traceability of Measurement (Rev. 1,
  2/17/10)

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Whats New?

• Example Excel Workbooks
• CALA Example Internal Calibration Workbook
• Example Chemistry Measurement Uncertainty
  Calculations
• Example Microbiology Measurement Uncertainty
  Calculations

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Important to Remember!

• Policy Documents Include Requirements
• Guidance Documents Include guidance and
  recommendations These are NOT Requirements but
  include acceptable approaches

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Policy on the Estimation of Uncertainty of
Measurement

• (MU Policy)
• 1. Scope
• 2. References
• 3. Terms and Definitions
• 4. Background
• 5. AIHA-LAP, LLC Uncertainty Policy
• 6. Assessment for Accreditation
• 7. Guidance and Examples

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Basis of MU Policy/Guidance

• References
• ISO/IEC 170252005 - General Requirements for
  the Competence of Testing and Calibration
  Laboratories
• Guide to the Uncertainty of Measurement (GUM)
  published by ISO, IEC, CIPM, BIPM, Eurachem, etc
• Quantifying Uncertainty in Analytical
  Measurement, 2nd Edition, 2000, Eurachem/CITAC
• APLAC TC 005 (2006) Interpretation and Guidance
  on the Estimation of Uncertainty of Measurement
  in Testing, Asia-Pacific Laboratory Cooperation
• ILAC Guide 17 Introducing the Concept of
  Uncertainty of Measurement in Testing in
  Association with the Application of the Standard
  ISO/IEC 17025. 2002, ILAC Rhodes, NSW,
  Australia.
• CALA P19 CALA Policy on the Estimation of
  Uncertainty of Measurement in Environmental
  Testing.

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Basis of MU Policy

• REQUIREMENTS
• ISO/IEC 17025 Section 5.4.6.2 Testing
  laboratories shall have and shall apply
  procedures for estimating uncertainty of
  measurement.
• ISO/IEC 17025 Section 5.4.6.3 When estimating
  the uncertainty of measurement, all uncertainty
  components which are of importance in the given
  situation shall be taken into account using
  appropriate methods of analysis.

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• uncertainty of measurement (VIM 2.26 JCGM
  2002008) non-negative parameter characterizing
  the dispersion of the quantity values being
  attributed to a measurand, based on the
  information used
• NOTE 1 Measurement uncertainty includes
  components arising from systematic effects, such
  as components associated with corrections and the
  assigned quantity values of measurement
  standards, as well as the definitional
  uncertainty. Sometimes estimated systematic
  effects are not corrected for but, instead,
  associated measurement uncertainty components are
  incorporated.
• NOTE 2 The parameter may be, for example, a
  standard deviation called standard measurement
  uncertainty (or a specified multiple of it), or
  the half-width of an interval having a stated
  coverage probability.

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• uncertainty of measurement (VIM 2.26 JCGM
  2002008)
• NOTE 3 Measurement uncertainty comprises, in
  general, many components. Some of these may be
  evaluated by Type A evaluation of measurement
  uncertainty from the statistical distribution of
  the quantity values from series of measurements
  and can be characterized by standard deviations.
  The other components, which may be evaluated by
  Type B evaluation of measurement uncertainty, can
  also be characterized by standard deviations,
  evaluated from probability density functions
  based on experience or other information.
• NOTE 4 In general, for a given set of
  information, it is understood that the
  measurement uncertainty is associated with a
  stated quantity value attributed to the
  measurand. A modification of this value results
  in a modification of the associated uncertainty.

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Basis of MU Policy

• REQUIREMENTS
• ISO/IEC 17025 Section 5.10.3.1 In addition to
  the requirements listed in 5.10.2, test reports
  shall, where necessary for the interpretation of
  the test results, include the following
• c) where applicable, a statement on the
  estimated uncertainty of measurement
  information on uncertainty is needed in test
  reports when it is relevant to the validity or
  application of the test results, when a
  customer's instruction so requires, or when the
  uncertainty affects compliance to a
  specification limit

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5.0 AIHA-LAP, LLC Uncertainty Policy

• The requirement which underlies this policy is
  given in ISO/IEC 17025, Clauses 5.4.6 and
  5.10.3.1 c).
• Laboratories accredited under the AIHA-LAP, LLC
  Accreditation Program shall fulfil the following
  requirements with respect to the estimation of
  uncertainty of measurement for tests associated
  with their scope of accreditation

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AIHA-LAP, LLC Uncertainty Policy

• 5.1 Laboratories shall be able to demonstrate
  their ability to estimate measurement uncertainty
  for all accredited quantitative test methods. In
  those cases where a rigorous estimation is not
  possible, the laboratory must make a reasonable
  attempt to estimate the uncertainty of test
  results. All approaches that provide a reasonable
  and valid estimation of uncertainty are equally
  acceptable.

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AIHA-LAP, LLC Uncertainty Policy

• 5.2 Laboratories shall make independent
  estimations of uncertainty for tests performed on
  samples with significantly different matrices.
  For example, estimations made for filter samples
  cannot be applied to bulk samples.
• 5.3 Estimations of measurement uncertainty are
  not needed where the reported test results are
  qualitative. Laboratories are, however, expected
  to have an understanding of the contributors to
  variability of test results. Examples of such
  tests are those that report only organism
  identifications or presence/absence.

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AIHA-LAP, LLC Uncertainty Policy

• 5.4 Laboratories shall have a written procedure
  describing the process used to estimate
  measurement uncertainty, including at a minimum
• 5.4.1 Definition of the measurand.

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• measurand (VIM 2.3 JCGM 2002008) quantity
  intended to be measured
• NOTE The specification of a measurand requires
  knowledge of the kind of quantity, description of
  the state of the phenomenon, body, or substance
  carrying the quantity, including any relevant
  component, and the chemical entities involved.
• NOTE In chemistry, analyte, or the name of a
  substance or compound, are terms sometimes used
  for measurand. This usage is erroneous because
  these terms do not refer to quantities

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AIHA-LAP, LLC Uncertainty Policy

• 5.4 Laboratories shall have a written procedure
  describing the process used to estimate
  measurement uncertainty, including at a minimum
• 5.4.1 Definition of the measurand.
• 5.4.2 Identification of the contributors to
  uncertainly.

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MU Guidance Document

• Consider the following categories or processes
  as listed by CALA and ILAC Guide 17
• Sampling or sub-sampling in-house sub-sampling
  typically applies only to bulk samples tested in
  AIHA-LAP, LLC laboratories. Note that field
  sampling is most often outside the
  responsibilities of the laboratory. In such
  cases, the laboratory should clearly state that
  any estimates of uncertainty reported with
  samples relate only to analytical uncertainty.
• Transportation, storage and handling of samples
• Preparation of samples -all steps of the sample
  procedure prior to analysis. This can include
  variations in drying, grinding, filtering,
  weighings, dispensing of materials, extractant
  backgrounds, etc.

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MU Guidance Document

• Consider the following categories or processes
  as listed by CALA and ILAC Guide 17
• Environmental and measurement conditions - those
  conditions that can impact some test results
  (e.g., gravimetry, microbiology) when they vary
  (e.g., temperature or humidity of the balance
  room, seasonal changes in microbiological
  background of micro labs, etc.).
• The personnel carrying out the tests -This is
  especially important with subjective tests such
  as microscopy and organism identification.
• Variations in the test procedure - for example,
  different recoveries for different batches of
  media, impurities in reagent lots, the effect of
  different extraction, digestion or incubation
  times and temperatures, percentages of
  microscopic samples read, etc.

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AIHA-LAP, LLC Uncertainty Policy

• Consider the following categories or processes
  as listed by CALA and ILAC Guide 17
• The measuring instruments - variations in
  baseline drift, day to day calibration
  differences, carry over effects, interferences
  specific to the test method, microscope
  magnification used, etc.
• Calibration standards or reference materials -
  uncertainty related to reference materials or due
  to preparation differences, etc. Uncertainty
  estimates may come from certificates of analysis
  or estimations based on provider claims.
• Methods of generating test results - uncertainty
  due to data interpretation (e.g., peak
  integration, baseline manipulation, etc.), blank
  corrections, differences in how the software was
  used, other data manipulations, etc.
• Corrections for systematic effects - if test
  results are corrected for bias, include the
  uncertainty of the correction.

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AIHA-LAP, LLC Uncertainty Policy

• 5.4 Laboratories shall have a written procedure
  describing the process used to estimate
  measurement uncertainty, including at a minimum
• 5.4.1 Definition of the measurand.
• 5.4.2 Identification of the contributors to
  uncertainly.
• 5.4.3 Details of the approaches used for
  estimating measurement uncertainty, such as Type
  A and/or Type B.

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• type A evaluation of measurement uncertainty (VIM
  2.28 JCGM 2002008) evaluation of a component of
  measurement uncertainty by a statistical analysis
  of measured quantity values obtained under
  defined measurement conditions
• NOTE 1 For various types of measurement
  conditions, see repeatability condition of
  measurement, intermediate precision condition of
  measurement, and reproducibility condition of
  measurement.
• type B evaluation of measurement uncertainty (VIM
  2.29 JCGM 2002008) evaluation of a component of
  measurement uncertainty determined by means other
  than a Type A evaluation of measurement
  uncertainty
• EXAMPLES Evaluation based on information
• associated with authoritative published
  quantity values,
• associated with the quantity value of a
  certified reference material,
• obtained from a calibration certificate,
• about drift,
• obtained from the accuracy class of a verified
  measuring instrument,
• obtained from limits deduced through personal
  experience.

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AIHA-LAP, LLC Uncertainty Policy

• When using the Type A approach, laboratories
  shall utilize one or more of the following
  options. These options are generally considered
  from 1) most suitable, to 4) least suitable
• 1) Uncertainty specified within a standard
  method. In those cases where a well-recognized
  test method (such as a peer-reviewed AOAC, NIOSH,
  OSHA, ASTM, etc. method), specifies limits to the
  values of the major sources of uncertainty of
  measurement and specifies the form of
  presentation of calculated results, laboratories
  need not do anything more than follow the
  reporting instructions as long as they can
  demonstrate they follow the reference method
  without modification and can meet the specified
  reliability.

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AIHA-LAP, LLC Uncertainty Policy

• 2) Laboratory Control Samples (LCS) and Matrix
  Spikes. In cases where matrix specific LCS (CRM
  or media spikes) and/or matrix spike data are
  available, include uncertainty estimated from the
  standard deviation of long term data collected
  from routine sample runs for existing test
  methods or from the standard deviation of the LCS
  or matrix spike data for method
  validation/verification studies for new test
  methods.

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AIHA-LAP, LLC Uncertainty Policy

• 3) Duplicate Data. In cases where sub-sampling
  occurs and there are data over the reporting
  limit, include uncertainty estimated from long
  term duplicate data collected from routine sample
  runs for existing test methods or method
  validation/verification studies for new test
  methods.
• 4) Proficiency Testing (PT) Sample Data. In cases
  where the previous options are not available and
  where PT samples are analyzed with sufficient
  data above the reporting limit, pooled PT sample
  data can be used to estimate uncertainty.

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AIHA-LAP, LLC Uncertainty Policy

• 5.4 Laboratories shall have a written procedure
  describing the process used to estimate
  measurement uncertainty, including at a minimum
• 5.4.4 Identification of the contributors of
  variability for qualitative test methods.
• 5.4.5 All calculations used to estimate
  measurement uncertainty and bias.
• 5.4.6 The reporting procedure.

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AIHA-LAP, LLC Uncertainty Policy

• 5.5 Laboratories are required to re-estimate
  measurement uncertainty when changes to their
  operations are made that may affect sources of
  uncertainty.
• 5.6 Laboratories shall report the expanded
  measurement uncertainty, along with the reported
  analyte concentration, in the same units as
  analyte concentration, when
• it is relevant to the validity or application
  of the test results, or
• a customer's instructions so requires, or
• the uncertainty affects compliance to a
  specification limit.

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AIHA-LAP, LLC Uncertainty Policy

• 5.7 When reporting measurement uncertainty, the
  test report shall include the coverage factor and
  confidence level used in the estimations
  (typically k approximately 2 at the 95
  confidence level).
• 5.8 When the test method has a known and
  uncorrected systematic bias, it shall be reported
  separately from the test result and uncertainty
  estimation, as a probable bias value

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• Expanded uncertainty (VIM 2.35 JCGM 2002008)
  product of a combined standard measurement
  uncertainty and a factor larger than the number
  one
• NOTE 1 The factor depends upon the type of
  probability distribution of the output quantity
  in a measurement model and on the selected
  coverage probability.
• NOTE 2 The term factor in this definition
  refers to a coverage factor.
• NOTE 3 Expanded measurement uncertainty is termed
  overall uncertainty in paragraph 5 of
  Recommendation INC-1 (1980) (see the GUM) and
  simply uncertainty in IEC documents.
• combined standard uncertainty (VIM 2.31 JCGM
  2002008) standard measurement uncertainty that
  is obtained using the individual standard
  measurement uncertainties associated with the
  input quantities in a measurement model

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Basis of MU Policy/Guidance

• Key Terms and Definitions
• coverage factor (VIM 2.38 JCGM 2002008) number
  larger than one by which a combined standard
  measurement uncertainty is multiplied to obtain
  an expanded measurement uncertainty
• NOTE A coverage factor, k, is typically in the
  range of 2 to 3.
• standard uncertainty (VIM 2.30 JCGM 2002008)
  measurement uncertainty expressed as a standard
  deviation

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Summary of Guidance Document Steps

• Review and identify the contributors
• Determine if contributors are accounted for with
  existing QC data
• Compile the applicable QC data and any other
  contributors and perform calculation of combined
  uncertainty

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Summary of Guidance Document Steps

• Combined uncertainty
• SDc v SD12 SD22 SDn2
• It may be beneficial to use RSD instead of SD as
  it allows for the concentration dependence of SD.
  
• NOTE Sources that have an SD of less than 1/3
  of the largest SD can be eliminated

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Summary of Guidance Document Steps

• Calculate the expanded uncertainty
• Apply the appropriate coverage factor 'k'.
  Calculate the expanded uncertainty by multiplying
  the combined standard uncertainty by the
  appropriate coverage factor (k) to give an
  expanded uncertainty with the desired confidence
  level. The factor k is the confidence interval
  Student distribution t-factor for n-1 degrees of
  freedom. For a confidence level of 95, k is
  approximately 2 for a data set of 30 points or
  more, for normally distributed data sets.
• Expanded measurement uncertainty k x SDc

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Summary of Guidance Document Steps

• Reporting test results with the expanded
  measurement uncertainty
• Total benzene concentration of 88 ug/sample 11
  ug/sample at the 95 confidence level (k2).
• Where bias is present, report it along with the
  uncertainty as a probable bias in a manner such
  as the following example
• Total lead concentration of 78 ug/sample 12
  ug/filter at the 95 confidence level (k2). This
  method has an average recovery of 94, or at this
  level, a probable bias of -5 ug/filter.
• Alternate forms of reporting uncertainty and bias
  are acceptable as long as required information is
  clearly presented.

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6. ASSESSMENT FOR ACCREDITATION

• During assessment and surveillance of a
  laboratory, the assessor will evaluate the
  capability of the laboratory to estimate the
  measurement uncertainty for test methods included
  in the laboratorys scope of accreditation. The
  assessor will verify that the methods of
  estimation applied are valid, all significant
  contributors to uncertainty have been considered,
  and all the criteria of the AIHA-LAP, LLC policy
  are met.

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Guidance and Examples

• Refer to the AIHA-LAP, LLC Guidance on the
  Estimation of Uncertainty of Measurement for
  suggestions and examples for implementing the
  policies and helpful references.
• Example Excel spreadsheets also on the website

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Guidance and Examples

• Example Chemistry Measurement Uncertainty
  Calculations workbook includes
• Common Contributors to Measurement Uncertainty
• Example contributors and calculations for
  Chromatography
• Example contributors and calculations for Lead in
  Paint

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Guidance and Examples

• Example Microbiology Measurement Uncertainty
  Calculations workbook includes
• Example contributors and calculations for Direct
  Examination Air
• Example contributors and calculations for
  culturable analyses (fungal swabs)

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Summary of Requirements

• Section 5.1 requires laboratories to be able to
  calculate an estimated measurement uncertainty,
  when requested, for all quantitative test methods
  covered by their AIHA LAP, LLC accreditation.
• Section 5.2 requires laboratories to treat each
  significantly different matrix (e.g., filters vs.
  bulks) separately when estimating measurement
  uncertainty.

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Summary of Requirements

• Section 5.3 addresses qualitative test methods.
  For these methods, laboratories are only required
  to understand the contributors to variability of
  test results and attempt to minimize them.

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Summary of Requirements

• Section 5.4 requires laboratories to have a
  written procedure describing how they estimate
  measurement uncertainty.
• Procedures must define the measurand, identify
  contributors to uncertainty, detail the approach
  that will be used to make the measurement
  uncertainty estimation, identify the calculations
  to be used to estimate measurement uncertainty
  and bias, and define how the information will be
  reported when required.
• Types of QC data that may be used in making the
  estimates are identified.

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Summary of Requirements

• Section 5.5 identifies conditions that will
  require laboratories to re-estimate measurement
  uncertainty of a test method.
• Section 5.6 defines when and how measurement
  uncertainty, as expanded measurement uncertainty,
  shall be reported.

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Summary of Requirements

• Section 5.7 requires the coverage factor used and
  confidence level to be included when reporting
  measurement uncertainty.
• Section 5.8 identifies requirements for reporting
  bias when it is known and a correction for it has
  not been applied to the reported result.

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Beginning April 1, 2010

• Your procedures must include all elements in
  Section 5 of the AIHA-LAP,LLC measurement
  uncertainty policy.
• The procedures must be implemented.
• All contributors to MU must be considered and
  dealt with in a defensible manner.
• The calculations must make sense.
• Your lab must have the ability to report MU, even
  if the customer is currently not requesting it.

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Questions?

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Traceability Documents

• Appendix H
• Policy on Traceability of  Measurement (Rev. 0,
  effect. April 1, 2010)
• Guidance on Traceability of Measurement (Rev. 1,
  2/17/10)
• CALA Example Internal Calibration Workbook

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Policy on the Traceability of Measurement

• (Traceability Policy)
• 1. Scope
• 2. References
• 3. Terms and Definitions
• 4. Background
• 5. Policy
• 6. Guidance on Implementing this Policy

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Basis of Traceability Policy

• References
• ISO/IEC 170252005 - General Requirements for
  the Competence of Testing and Calibration
  Laboratories
• ILAC-P10 Policy on Traceability of Measurement
  Results
• ILAC-G24 Guidelines for the determination of
  calibration intervals of measuring instruments
• CALA A61 CALA Traceability Policy (CALA)

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4. BACKGROUND

• Traceability is characterized (in ILAC documents
  and the VIM) by 6 basic requirements
• (a) an unbroken chain of comparisons going back
  to stated references acceptable to the parties,
  usually a national or international standard
• (b) uncertainty of measurement the uncertainty
  of measurement for each step in the traceability
  chain must be calculated or estimated according
  to agreed methods and must be stated so that an
  overall uncertainty for the whole chain may be
  calculated or estimated

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4. BACKGROUND

• Traceability is characterized (in ILAC documents
  and the VIM) by
• (c) documentation each step in the traceability
  chain must be performed according to documented
  and generally acknowledged procedures the
  results must be recorded
• (d) competence the laboratories or bodies
  performing one or more steps in the traceability
  chain must supply evidence for their technical
  competence (e.g. by demonstrating that they are
  accredited for that activity)

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4. BACKGROUND

• Traceability is characterized (in ILAC documents
  and the VIM) by
• (e) reference to SI units the chain of
  comparisons must, where possible, end at primary
  standards for the realization of the SI units
• (f) calibration intervals calibrations must be
  repeated at appropriate intervals the length of
  these intervals will depend on a number of
  variables (e.g. uncertainty required, frequency
  of use, way of use, stability of the equipment).

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4. BACKGROUND

• AIHA-LAP, LLC accredited laboratories must
  understand the following simple relationship. All
  three of these components must exist at every
  level in the traceability chain in order for the
  final test result to be traceable.
• Calibration (1) with Uncertainty (2) produces a
  measurement result that is Traceable (3)

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Basis of Traceability Policy/Guidance

• Requirements
• ISO/IEC 17025, Clause 5.6
• 5.6.1 All equipment used for tests and/or
  calibrations, including equipment for subsidiary
  measurements (e.g. for environmental conditions)
  having a significant effect on the accuracy or
  validity of the result of the test, calibration
  or sampling shall be calibrated before being put
  into service. The laboratory shall have an
  established programme and procedure for the
  calibration of its equipment.
• 5.6.2 specific requirements for calibration and
  testing
• 5.6.3 reference standards and reference
  materials

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• The requirement which underlies this policy is
  given in ISO/IEC 17025, Clause 5.6.
• 5.1 Laboratories accredited by AIHA-LAP, LLC
  shall demonstrate, when possible, that
  calibrations of critical equipment and hence the
  measurement results generated by that equipment,
  relevant to their scope of accreditation, are
  traceable to the SI through an unbroken chain of
  calibrations.

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.2 External calibration services shall, wherever
  possible, be obtained from providers accredited
  to ISO/IEC 17025 by an ILAC recognized signatory.
  Calibration certificates shall be endorsed by a
  recognized accreditation body symbol.
  Certificates shall indicate traceability to the
  SI or reference standard and include the
  measurement result with the associated
  uncertainty of measurement.

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.3 Where traceability to the SI is not
  technically possible or reasonable, the
  laboratory shall use certified reference
  materials provided by a competent supplier (refer
  to ISO/IEC 17025 4.6.4), or use specified methods
  and/or consensus standards that are clearly
  described and agreed to by all parties concerned.
  A competent supplier is an NMI or an accredited
  reference material provider (RMP) that conforms
  with ISO Guide 34 in combination with ISO/IEC
  17025, or ILAC Guidelines for the Competence of
  Reference Material Producers, ILAC G12.
  Conformance is demonstrated through accreditation
  by an ILAC recognized signatory.

62
5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• NOTE There are many gaps in the measurement
  traceability of the calibration infrastructure in
  the world and there are a relatively small number
  of accredited reference material providers. In
  recognition of this situation, AIHA-LAP, LLC will
  not require the use of accredited reference
  material providers, where applicable, until
  January 2012. AIHA-LAP, LLC assessors will, at
  present, note any nonconformity with this
  requirement of Section 5.3 of this policy as a
  suggestion for improvement.

63
5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.4 Reference materials shall have a certificate
  of analysis that documents traceability to a
  primary standard or certified reference material
  and associated uncertainty, when possible. When
  applicable, the certificate must document the
  specific NIST SRM or NMI certified reference
  material used for traceability.

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.5 Calibrations performed in-house shall be
  documented in a manner that demonstrates
  traceability via an unbroken chain of
  calibrations regarding the reference
  standard/material used, allowing for an overall
  uncertainty to be estimated for the in-house
  calibration.
• 5.6 Calibrations shall be repeated at appropriate
  intervals, the length of which can be dependant
  on the uncertainty required, the frequency of use
  and verification, the manner of use, stability of
  the equipment, and risk of failure
  considerations. Table 5-1 provides the minimum
  frequencies that are required.

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.7 Periodic verifications shall be performed to
  demonstrate the continued validity of the
  calibration at specified intervals between
  calibrations. The frequency of verifications can
  be dependent on the uncertainty required, the
  frequency of use, the manner of use, stability of
  the equipment, and risk of failure
  considerations. Table 5-1 provides the minimum
  frequencies that are required.

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5. AIHA-LAP, LLC TRACEABILITY OF MEASUREMENT
POLICY

• 5.8 The laboratory shall have procedures
  describing their external and internal
  calibration and verification activities and
  frequencies, and the actions to follow if the
  equipment is found to be out of acceptable
  specification.
• 5.9 Laboratory staff performing in-house
  calibrations and verifications shall have
  received documented training.

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Table 5-1 Minimum Calibration/Verification
Frequency Requirements for Common Reference
Standards and Support Equipment
Reference Standard / Equipment Calibration Frequency Verification Frequency
Reference Thermometer Initial and every 5 years Not applicable
Working Thermometer Initial and when verification fails Annually
Reference Masses Initial and every 5 years Not applicable
Working Masses NA Initial and then annually
Stage Micrometer Initial and if damaged Not applicable
Balance Initial and following service/repair or when verification fails Each day of use
Mechanical Pipettes Initial and when verification fails Annual
Volumetric Containers for critical functions (non-Class A) Not applicable Each lot prior to use

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Table 5-1 Minimum Calibration/Verification
Frequency Requirements for Common Reference
Standards and Support Equipment

• NOTE It is imperative laboratories understand
  that this table is not a list of recommended
  frequencies. Rather, they are the minimum
  frequencies that will be accepted by AIHA-LAP,
  LLC assessors. It is the laboratorys
  responsibility to establish a suitable schedule.

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Guidance Document and Examples

• Refer to the AIHA-LAP, LLC Guidance on the
  Traceability of Measurement for suggestions and
  examples for implementing the policies and
  helpful references.

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Guidance Document Includes

• Information to help determine what equipment
  needs calibration or verification and the
  frequency at which these are needed.
• Important considerations when purchasing
  reference standards and calibration services,
  including content of calibration certificates.

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Guidance Document Includes

• Considerations when performing in-house
  calibrations and verifications of various types
  of analytical instruments and support equipment.
• Tables listing Uncertainty Contributors when
  calibrating balances, thermometers and pipettes.

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Guidance Document and Examples
Uncertainty Contribution Table for Thermometers Uncertainty Contribution Table for Thermometers Uncertainty Contribution Table for Thermometers Uncertainty Contribution Table for Thermometers
Contribution (nomenclature) Contribution (nomenclature) Distribution Estimated Value
ur Standard uncertainty of the nominal values of the reference thermometer. Normal Expanded uncertainty on the calibration certificate of the reference thermometer divided by 2 (coverage factor k)
sp Standard deviation of the set of calibration readings Normal Standard deviation of the set of calibration measurements.
u1 Standard uncertainty of the readability and resolution of the working thermometer Uniform (Square) Smallest gradation of the working thermometer divided by v3. Use ONLY if Sp 0
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Guidance Document and Examples
Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes
Contribution (nomenclature) Contribution (nomenclature) Distribution Estimated Value
ur Standard uncertainty of the nominal values of the reference balance. Normal Expanded uncertainty on the calibration certificate of the reference balance divided by 2 (coverage factor k)
Sp Standard deviation of the set of calibration readings Normal Standard deviation of the set of calibration measurements.
ST Standard deviation of corrections caused by temperature (?T) when the temperature differs from standard temperature (20oC). The thermal coefficient of expansion of water is 0.00021 per 1 Celsius at 20 Celsius. Uniform (Square) Relative Standard Deviation (?T x 0.0002) / (v3) in millilitres per millilitre
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Guidance Document and Examples
Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes Uncertainty Contribution Table for Pipettes
Contribution (nomenclature) Contribution (nomenclature) Distribution Estimated Value
u1 Standard uncertainty of the readability and resolution of the working volumetric instrument Uniform (Square) Smallest gradation of the working volumetric instrument divided by v3. Use ONLY if Sp 0
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Additional Guidance Document Content

• Guidance on how to find an ILAC recognized
  accredited calibration laboratory.
• Guidance on selecting reference material
  providers, including sources for identifying
  those that are ILAC recognized.

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Guidance Document and Examples

• Example Excel calibration worksheets are also
  found on the AIHA website.
• Key concept to remember traceable calibration
  must also include uncertainty.
• Calculate the combined uncertainty
• SDc v SD12 SD22 SDn2
• Calculate the expanded uncertainty
• Apply a coverage factor 2'.

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Summary of Traceability Policy

• Section 5.1 requires laboratories to demonstrate,
  when possible, that their analytical results are
  traceable to the SI (International System of
  Units) through an unbroken chain of calibrations
  within the measuring system. This requirement can
  be met for weights (masses), balances,
  thermometers, volumetric ware (e.g., mechanical
  pipettes) and stage micrometers.
• Section 5.2 expands upon the required information
  that must be included in calibration certificates
  received from accredited external calibration
  services.

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Summary of Traceability Policy

• Section 5.3 details requirements for providing
  traceability of analytical results when
  traceability to the SI is not possible (most
  chemical and microbiological analyses). Included
  are requirements for providers of reference
  materials. Because there are currently only a few
  accredited reference material producers, use of
  these producers will be encouraged where
  available but not mandated until 2012.
  Traceability options using specified methods or
  consensus standards are also provided.

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Summary of Traceability Policy

• Section 5.4 requires certificates of analysis for
  reference materials and defines information that
  is required on the certificates.
• Section 5.5 addresses documentation required for
  in-house calibrations and requires these
  calibrations to include an estimation of the
  overall measurement uncertainty.
• Section 5.6 requires laboratories to establish
  the frequency at which calibrations will be
  repeated. A table of minimum calibration
  frequencies for reference standards and support
  equipment is included.

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Summary of Traceability Policy

• Section 5.7 requires laboratories to also
  establish a frequency for and perform calibration
  verifications to demonstrate the continued
  validity of the calibrations. A table of minimum
  verification frequencies is provided
• Section 5.8 requires laboratories to have
  procedures that describe internal and external
  calibration and verification activities and their
  frequencies. These procedures must also describe
  the actions to be taken if equipment is found to
  be performing outside of acceptable
  specifications.
• Section 5.9 requires laboratories to maintain
  documentation demonstrating that personnel who
  perform in-house calibrations and verifications
  have been trained to perform these activities.

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As of April 1, 2010

• Traceability procedure(s) must include all
  elements from the AIHA-LAP, LLC policy.
• The procedure(s) must be implemented.
• All equipment must be considered and those with a
  significant impact on test results should be
  dealt with in a defensible manner.
• The calculations used follow the MU policy

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Next Steps

• .25 CM points were granted for the March 11 MU
  and Traceability Webinar
• Will also apply for CM points this Webinar
• We are collecting questions from both Webinars
  with the goal of developing a FAQ to post on the
  AIHA-LAP, LLC website in late June.
• Thank you for participating!

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Questions?